Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery
Status: | Recruiting |
---|---|
Conditions: | Cervical Cancer, Cancer, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/25/2017 |
Start Date: | April 12, 2010 |
Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy
This randomized phase III trial studies radiation therapy with chemotherapy to see how well
it works compared to radiation therapy alone in treating patients with stage I or stage II
cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays
to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. It is not yet known whether giving radiation therapy together with chemotherapy is
more effective than radiation therapy alone in treating patients with cervical cancer.
it works compared to radiation therapy alone in treating patients with stage I or stage II
cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays
to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. It is not yet known whether giving radiation therapy together with chemotherapy is
more effective than radiation therapy alone in treating patients with cervical cancer.
PRIMARY OBJECTIVES:
I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly
improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage
I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical
hysterectomy.
SECONDARY OBJECTIVES:
I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when
compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors
after treatment with radical hysterectomy.
II. To assess differences (across treatment arms) in incidence and severity of
therapy-attributed adverse events utilizing the active version of Common Terminology Criteria
for Adverse Events (CTCAE).
III. To provide assessment of patient risk vs benefit (positive study only). IV. To determine
whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL)
(compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix
(FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular
focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual
adverse events).
TERTIARY OBJECTIVES:
I. To bank archival tumor tissue for research studies, including studies that evaluate the
association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in
patients randomized to post-operative adjuvant CRT compared to RT alone.
II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including
studies that evaluate associations between single nucleotide polymorphisms (SNPs), and
measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to
post-operative adjuvant CRT compared to RT alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated
radiation therapy (IMRT) 5 days a week for 5.5 weeks.
ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in
Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly
improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage
I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical
hysterectomy.
SECONDARY OBJECTIVES:
I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when
compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors
after treatment with radical hysterectomy.
II. To assess differences (across treatment arms) in incidence and severity of
therapy-attributed adverse events utilizing the active version of Common Terminology Criteria
for Adverse Events (CTCAE).
III. To provide assessment of patient risk vs benefit (positive study only). IV. To determine
whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL)
(compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix
(FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular
focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual
adverse events).
TERTIARY OBJECTIVES:
I. To bank archival tumor tissue for research studies, including studies that evaluate the
association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in
patients randomized to post-operative adjuvant CRT compared to RT alone.
II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including
studies that evaluate associations between single nucleotide polymorphisms (SNPs), and
measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to
post-operative adjuvant CRT compared to RT alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated
radiation therapy (IMRT) 5 days a week for 5.5 weeks.
ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in
Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
Inclusion Criteria:
- Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma,
adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical
hysterectomy with pelvic lymphadenectomy
- Patients with the following characteristics (depth of stromal invasion and
lymphovascular space involvement to be pathologically confirmed):
- Positive capillary-lymphovascular space involvement and one of the following:
- Deep third penetration
- Middle third penetration, clinical tumor >/=2 cm
- Superficial third penetration, clinical tumor >/=5 cm
- Negative capillary-lymphatic space involvement
- Middle or deep third penetration, clinical tumor >/= 4 cm
- Absolute neutrophil count (ANC) >/= 1,500/mcl
- Platelets >/= 100,000/mcl
- Creatinine = upper limit of normal (ULN) or calculated creatinine clearance >/= 60
mL/min
- Bilirubin = 1.5 times normal
- Alkaline phosphate = 3 times normal
- Serum glutamic oxaloacetic transaminase (SGOT) ? 3 times normal
- Gynecologic Oncology Group (GOG) performance status 0, 1, 2
- Patients should not be randomized less than 3 weeks post-surgery but will not be
acceptable for randomization more than 8 weeks post-surgery
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting
release of personal health information
Exclusion Criteria:
- Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine
site or with positive surgical margins
- Patients with septicemia or severe infection
- Patients with intestinal obstruction or gastrointestinal bleeding
- Patients with postoperative fistula
- Patients with cervix cancer who have received any previous radiation or chemotherapy
- Patients whose circumstances do not permit completion of the study or the required
follow-up
- Patients with renal abnormalities requiring modification of radiation field (pelvic
kidney, renal transplant, etc.)
- Patients with GOG performance status of 3 or 4
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years; patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy
We found this trial at
613
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Nampa, Idaho 83686
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946

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Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1201 Camino de Salud Northeast
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Albuquerque, New Mexico 87131
(505) 272-4946

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2545 Schoenersville Rd
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Bethlehem, Pennsylvania 18017
(484) 884-2200

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Phone: 208-367-7954
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1 Hurley Plaza
Flint, Michigan 48503
Flint, Michigan 48503
(810) 262-9000

Principal Investigator: J. R. Liu
Phone: 208-367-7954
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301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011

Principal Investigator: Lyuba Levine
Phone: 713-792-3245
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000

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Phone: 601-815-6700
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 382-2500

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Phone: 616-391-1230
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Portland, Oregon 97213
(503) 215-1111

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620 John Paul Jones Cir
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Portsmouth, Virginia 23708
(757) 953-5008

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401 College Street
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Richmond, Virginia 23298
(804) 828-0450

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60 Crittenden Blvd # 70
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Rochester, New York 14642
(585) 275-2121

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Phone: 585-341-8113
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Phone: 907-212-6871
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000

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Phone: 425-899-3181
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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825 Eastlake Ave E
Seattle, Washington 98109
Seattle, Washington 98109
(206) 288-7222

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Phone: 425-899-3181
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
(605) 322-4700

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Phone: 888-634-7268
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601 South Sherman Street
Spokane, Washington 99202
Spokane, Washington 99202
(509) 228-1000

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Phone: 425-899-3181
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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808 North 39th Avenue
Yakima, Washington 98902
Yakima, Washington 98902
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Phone: 503-215-6412
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Aberdeen, Washington 98520
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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1200 Old York Road
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
(215) 481–2000

Principal Investigator: Joel I. Sorosky
Phone: 215-481-2402
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Akron General Medical Center It
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Akron, Ohio 44304
Principal Investigator: Stephen J. Andrews
Phone: 330-615-4132
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Albany, New York 12208
Principal Investigator: Daniel C. Kredentser
Phone: 518-458-1390
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Albuquerque, New Mexico 87106
Principal Investigator: Carolyn Y. Muller
Phone: 505-925-0366
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Albuquerque, New Mexico 87102
Principal Investigator: Carolyn Y. Muller
Phone: 505-925-0366
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4650 Jefferson Lane Northeast
Albuquerque, New Mexico 87109
Albuquerque, New Mexico 87109
Principal Investigator: Carolyn Y. Muller
Phone: 505-925-0366
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Allentown, Pennsylvania 18103
Principal Investigator: J. R. Liu
Phone: 208-367-7954
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170 North 1100 East
American Fork, Utah 84003
American Fork, Utah 84003
Principal Investigator: R. J. Lee
Phone: 801-408-1347
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Principal Investigator: Joseph J. Merchant
Phone: 515-239-2621
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1111 Duff Ave
Ames, Iowa 50010
Ames, Iowa 50010
(866) 972-5477

Principal Investigator: Joseph J. Merchant
Phone: 515-239-2621
McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
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Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anacortes, Washington 98221
Principal Investigator: Paul G. Montgomery
Phone: 208-381-3376
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Anchorage, Alaska 99508
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Keith S. Lanier
Phone: 503-215-6412
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Anchorage, Alaska 99508
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Anchorage, Alaska 99504
Principal Investigator: Keith S. Lanier
Phone: 503-215-6412
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Anchorage, Alaska 98508
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456

Principal Investigator: J. R. Liu
Phone: 208-367-7954
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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364 White Oak St
Asheboro, North Carolina 27203
Asheboro, North Carolina 27203
(336) 625-5151

Principal Investigator: James M. Granfortuna
Phone: 336-832-0821
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001

Principal Investigator: Thomas E. Seay
Phone: 404-303-3355
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(404) 851-8000

Principal Investigator: Guilherme Henrique C. Cantuaria
Phone: 404-303-3355
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Auburn, California 95602
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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Auburn, California 95603
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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Principal Investigator: John A. Keech
Phone: 907-458-5380
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Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
Phone: 888-785-6789
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1501 S Potomac St
Aurora, Colorado 80012
Aurora, Colorado 80012
(303) 695-2600

Principal Investigator: Keren Sturtz
Phone: 888-785-6789
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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2000 Ogden Ave
Aurora, Illinois 60504
Aurora, Illinois 60504
(630) 978-6200

Principal Investigator: Sinisa Stanic
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Austin, Texas 78702
Principal Investigator: James S. Ferriss
Phone: 215-728-2983
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Austin, Texas 78758
Principal Investigator: James S. Ferriss
Phone: 215-728-2983
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1500 Red River Street
Austin, Texas 78701
Austin, Texas 78701
Principal Investigator: James S. Ferriss
Phone: 215-728-2983
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Bainbridge Island, Washington 98110
Principal Investigator: John A. Keech
Phone: 907-458-5380
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
Principal Investigator: J. R. Liu
Phone: 208-367-7954
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Principal Investigator: Mario M. Leitao
Phone: 212-639-7202
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Principal Investigator: Mindy W. Bowie
Phone: 412-339-5294
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Principal Investigator: Patricia S. Braly
Phone: 225-215-1353
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Principal Investigator: John A. Keech
Phone: 907-458-5380
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Principal Investigator: Keith S. Lanier
Phone: 503-215-6412
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Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417

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Phone: 614-566-3275
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Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Berkeley, California 94704
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000

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Phone: 301-319-2100
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Principal Investigator: Nicholas P. Taylor
Phone: 610-954-3582
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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1233 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-237-7000

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Phone: 800-648-6274
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102

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Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Principal Investigator: James L. Wade
Phone: 217-876-4740
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100 E Idaho St
Boise, Idaho 83712
Boise, Idaho 83712
(208) 381-2711

Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Principal Investigator: J. R. Liu
Phone: 208-367-7954
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1501 North Oakland Drive
Bolivar, Missouri 65613
Bolivar, Missouri 65613
417-326-7200

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Phone: 888-221-4849
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Bonne Terre, Missouri 63628
Principal Investigator: James L. Wade
Phone: 309-243-3605
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Principal Investigator: Joseph J. Merchant
Phone: 515-239-2621
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1100 Balsam Ave
Boulder, Colorado 80304
Boulder, Colorado 80304
(303) 440-2273

Principal Investigator: Keren Sturtz
Phone: 888-785-6789
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Principal Investigator: Keren Sturtz
Phone: 888-785-6789
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000

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Phone: 406-969-6060
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Branson, Missouri 65616
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
Phone: 208-367-7954
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Brooklyn, New York 11203
Principal Investigator: Ovadia Abulafia
Phone: 718-613-8324
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263 7th Avenue
Brooklyn, New York 11215
Brooklyn, New York 11215
Principal Investigator: Katherine Economos
Phone: 718-780-3677
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Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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