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

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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.

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.

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 /= 60
mL/min

- Bilirubin
- Alkaline phosphate
- 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
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100 North Academy Avenue
Danville, Pennsylvania 17822
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1201 Camino de Salud Northeast
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
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1 Hurley Plaza
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301 University Blvd
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2500 N State St
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8700 Beverly Blvd # 8211
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4805 Northeast Glisan Street
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620 John Paul Jones Cir
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60 Crittenden Blvd # 70
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Seattle, Washington 98104
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1100 Fairview Avenue North
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5301 McAuley Drive
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1501 S Potomac St
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6701 N Charles St
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800 Farson Street
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1233 North 30th Street
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100 E Idaho St
Boise, Idaho 83712
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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1501 North Oakland Drive
Bolivar, Missouri 65613
417-326-7200
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915 Highland Blvd
Bozeman, Montana 59715
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
Phone: 208-367-7954
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Brighton, MI
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
Phone: 208-367-7954
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Brighton, MI
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Brooklyn, New York 11203
Principal Investigator: Ovadia Abulafia
Phone: 718-613-8324
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Brooklyn, NY
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263 7th Avenue
Brooklyn, New York 11215
Principal Investigator: Katherine Economos
Phone: 718-780-3677
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Brooklyn, NY
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Burbank, California
Principal Investigator: Benjamin B. Bridges
Phone: 907-212-6871
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Burbank, CA
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