Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | March 2008 |
Contact: | Jeffrey A. Bogart, MD |
Phone: | 315 464-5276 |
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as etoposide, carboplatin and 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 which radiation therapy regimen is more effective when given together with chemotherapy
in treating patients with limited-stage small cell lung cancer. This randomized phase III
trial is comparing different chest radiation therapy regimens to see how well they work in
treating patients with limited-stage small cell lung cancer.
such as etoposide, carboplatin and 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 which radiation therapy regimen is more effective when given together with chemotherapy
in treating patients with limited-stage small cell lung cancer. This randomized phase III
trial is comparing different chest radiation therapy regimens to see how well they work in
treating patients with limited-stage small cell lung cancer.
OUTLINE: This is a 2-part, multicenter, randomized study. Patients are stratified according
to gender, weight loss 6 months prior to study entry (≤ 5% of body weight vs > 5% of body
weight), ECOG performance status (0 vs 1 vs 2), radiotherapy technique (intensity-modulated
radiotherapy vs 3-dimensional conformal radiotherapy), radiotherapy start time (at first
cycle of protocol chemotherapy, after one cycle of prior non-protocol chemotherapy vs at
first cycle of protocol chemotherapy, without prior non-protocol chemotherapy vs at second
cycle of protocol chemotherapy, without prior non-protocol chemotherapy) and chemotherapy
backbone: carboplatin vs cisplatin.
OBJECTIVES:
Primary Objective
To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily
over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9
days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3
weeks) in patients with limited stage small cell lung cancer.
Secondary Objectives
1. To compare treatment related toxic effects of thoracic radiotherapy regimens in patients
with limited stage small cell lung cancer
2. To compare response rates, failure-free survival and toxicity of thoracic radiotherapy
regimens in patients with limited stage small cell lung cancer
3. To compare rates of local relapse, distant metastases and brain metastases with these
regimens
4. To compare patients' quality of life between these treatment regimens in terms of their
physical symptoms, physical functioning and psychological state
5. To describe the patterns of use of thoracic intensity modulated radiation therapy (IMRT)
in patients with limited stage small cell lung cancer
6. To examine blood-based biomarkers of response and resistance to cisplatin (or
carboplatin) and etoposide
7. To evaluate the correspondence between increases in plasma ProGRP concentrations and
disease progression/recurrence
8. To evaluate the potential for plasma ProGRP concentrations at baseline, after each cycle
of chemotherapy and at first evaluation following completion of chemotherapy to predict
PFS and OS
9. To evaluate the correspondence between longitudinal decreases in plasma ProGRP
concentrations and clinical response
Part 1: Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients undergo standard-dose (45 Gy given in 30 treatments) thoracic radiotherapy
twice daily, 5 days a week, for 3 weeks. Patients also receive cisplatin IV on day 1 or
carboplatin IV and etoposide IV on days 1, 2, and 3.
Arm II: Patients undergo higher-dose (70 Gy given in 35 treatments) thoracic radiotherapy
once daily, 5 days a week, for 7 weeks. Patients also receive cisplatin or carboplatin and
etoposide as in arm I.
Arm III: (discontinued as of 03/10/13) Patients undergo mid-dose (61.2 Gy given in 34
treatments) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days
(approximately 3 weeks) of treatment and then twice daily, 5 days a week, for the final 9
days (approximately 2 weeks) of treatment. Patients also receive cisplatin and etoposide.
In all arms, treatment with cisplatin and etoposide repeats every 21 days for 4 courses in
the absence of disease progression or unacceptable toxicity.
Part 2: An interim analysis was conducted after accrual of 30 patients per arm and one
experimental arm based upon a comparison of treatment-related toxicity was selected. The most
toxic experimental arm was discontinued, and the trial continues comparing standard therapy
(arm I) to the selected experimental regimen (arm II) as described in part 1. Please see the
Arms section for more information regarding Part 2.
Prophylactic cranial irradiotherapy (PCI): Within 3-6 weeks after completion of chemotherapy,
PCI should be offered to all patients with a complete tumor response (CR) or near complete
response (nCR) with only residual chest abnormalities of indeterminate nature following
completion of combined modality therapy.
After completion of study treatment, patients are followed up at least every 3 months for 2
years, every 6 months for 3 years, and then annually for 5 years or until disease
progression. At disease progression, patients are followed up every 6 months.
to gender, weight loss 6 months prior to study entry (≤ 5% of body weight vs > 5% of body
weight), ECOG performance status (0 vs 1 vs 2), radiotherapy technique (intensity-modulated
radiotherapy vs 3-dimensional conformal radiotherapy), radiotherapy start time (at first
cycle of protocol chemotherapy, after one cycle of prior non-protocol chemotherapy vs at
first cycle of protocol chemotherapy, without prior non-protocol chemotherapy vs at second
cycle of protocol chemotherapy, without prior non-protocol chemotherapy) and chemotherapy
backbone: carboplatin vs cisplatin.
OBJECTIVES:
Primary Objective
To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily
over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice-daily for 9
days), will improve median and 2-year survival compared with 45 Gy (1.5 Gy twice-daily over 3
weeks) in patients with limited stage small cell lung cancer.
Secondary Objectives
1. To compare treatment related toxic effects of thoracic radiotherapy regimens in patients
with limited stage small cell lung cancer
2. To compare response rates, failure-free survival and toxicity of thoracic radiotherapy
regimens in patients with limited stage small cell lung cancer
3. To compare rates of local relapse, distant metastases and brain metastases with these
regimens
4. To compare patients' quality of life between these treatment regimens in terms of their
physical symptoms, physical functioning and psychological state
5. To describe the patterns of use of thoracic intensity modulated radiation therapy (IMRT)
in patients with limited stage small cell lung cancer
6. To examine blood-based biomarkers of response and resistance to cisplatin (or
carboplatin) and etoposide
7. To evaluate the correspondence between increases in plasma ProGRP concentrations and
disease progression/recurrence
8. To evaluate the potential for plasma ProGRP concentrations at baseline, after each cycle
of chemotherapy and at first evaluation following completion of chemotherapy to predict
PFS and OS
9. To evaluate the correspondence between longitudinal decreases in plasma ProGRP
concentrations and clinical response
Part 1: Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients undergo standard-dose (45 Gy given in 30 treatments) thoracic radiotherapy
twice daily, 5 days a week, for 3 weeks. Patients also receive cisplatin IV on day 1 or
carboplatin IV and etoposide IV on days 1, 2, and 3.
Arm II: Patients undergo higher-dose (70 Gy given in 35 treatments) thoracic radiotherapy
once daily, 5 days a week, for 7 weeks. Patients also receive cisplatin or carboplatin and
etoposide as in arm I.
Arm III: (discontinued as of 03/10/13) Patients undergo mid-dose (61.2 Gy given in 34
treatments) thoracic radiotherapy once daily, 5 days a week, during the initial 16 days
(approximately 3 weeks) of treatment and then twice daily, 5 days a week, for the final 9
days (approximately 2 weeks) of treatment. Patients also receive cisplatin and etoposide.
In all arms, treatment with cisplatin and etoposide repeats every 21 days for 4 courses in
the absence of disease progression or unacceptable toxicity.
Part 2: An interim analysis was conducted after accrual of 30 patients per arm and one
experimental arm based upon a comparison of treatment-related toxicity was selected. The most
toxic experimental arm was discontinued, and the trial continues comparing standard therapy
(arm I) to the selected experimental regimen (arm II) as described in part 1. Please see the
Arms section for more information regarding Part 2.
Prophylactic cranial irradiotherapy (PCI): Within 3-6 weeks after completion of chemotherapy,
PCI should be offered to all patients with a complete tumor response (CR) or near complete
response (nCR) with only residual chest abnormalities of indeterminate nature following
completion of combined modality therapy.
After completion of study treatment, patients are followed up at least every 3 months for 2
years, every 6 months for 3 years, and then annually for 5 years or until disease
progression. At disease progression, patients are followed up every 6 months.
1. Documentation of Disease
1. Histologically or cytologically documented small cell lung cancer (SCLC)
2. Limited-stage disease patients with disease restricted to one hemithorax with
regional lymph node metastases, including ipsilateral hilar, ipsilateral and
contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
- Patients with disease involvement of the contralateral hilar or
supraclavicular lymph nodes are not eligible
- Patients with pleural effusions that are visible on plain chest radiographs,
whether cytologically positive or not are not eligible unless they have a
negative thoracentesis
- Patients with cytologically positive pleural or pericardial fluid,
regardless of the appearance on plain x-ray are not eligible
2. Measurable disease - Patients must have measurable disease, which includes lesions
that can be accurately measured in at least one dimension (longest diameter to be
recorded) as ≥ 2 cm with conventional techniques OR ≥ 1 cm by spiral CT scan
3. Prior Treatment
1. Patients may have received one and only one cycle of chemotherapy prior to
enrolling on CALGB 30610, which must have included carboplatin or cisplatin and
etoposide.
2. If a patient has had one cycle of cisplatin or carboplatin/etoposide prior to
registration, the patient must have had all of it prior to registration tests as
outlined in the protocol and prior to starting their first cycle of chemotherapy.
3. Additionally, these patients also must have met all of the eligibility criteria
in the protocol prior to receiving the first cycle of chemotherapy.
4. Registration to CALGB 30610 must take place within 14-21 days after the start of
the non-protocol therapy.
5. Failing to do all of the above will make the patient NOT eligible for CALGB
30610.
6. No prior radiotherapy or chemotherapy (except for the chemotherapy described in
the bullet above) for SCLC
7. No prior mediastinal or thoracic radiotherapy
8. Patients with complete surgical resection of disease are not eligible
4. Age Requirement ≥ 18 years of age
5. ECOG Performance Status 0-2
6. Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing
7. Required Initial Laboratory Values
1. Granulocytes ≥ 1,500/µl
2. Platelet count ≥ 100,000/µl
3. Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
4. AST (SGOT) ≤ 2.0 times ULN
5. Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min
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1501 S Potomac St
Aurora, Colorado 80012
Aurora, Colorado 80012
(303) 695-2600
![Medical Center of Aurora](/wp-content/uploads/logos/medical-center-of-aurora.jpg)
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
![University of Colorado Hospital](/wp-content/uploads/logos/university-of-colorado-hospital-site.jpg)
Principal Investigator: Brian D. Kavanagh
Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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2000 Ogden Ave
Aurora, Illinois 60504
Aurora, Illinois 60504
(630) 978-6200
![Rush - Copley Medical Center](/wp-content/uploads/logos/rush---copley-medical-center.png)
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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Aventura, Florida 33180
Principal Investigator: Michael A. Schwartz
Phone: 305-674-2625
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Bakersfield, California 93301
Principal Investigator: David R. Gandara
Phone: 661-323-4673
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Baltimore, Maryland 21229
Principal Investigator: Richard S. Hudes
Phone: 410-368-2910
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2401 W Belvedere Ave
Baltimore, Maryland 21215
Baltimore, Maryland 21215
(410) 601-9000
![Sinai Hospital of Baltimore](/wp-content/uploads/logos/sinai-hospital-of-baltimore.jpg)
Principal Investigator: Jeanette A. Linder
Phone: 410-601-6120
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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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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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
![University of Maryland Greenebaum Cancer Center](/wp-content/uploads/logos/university-of-maryland-greenebaum-cancer-center.jpg)
Principal Investigator: Pranshu Mohindra
Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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Basking Ridge, New Jersey 07920
Principal Investigator: Andreas Rimner
Phone: 212-639-5007
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Baton Rouge, Louisiana 70806
Principal Investigator: William R. Robinson
Phone: 225-381-6451
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70809
Principal Investigator: Augusto C. Ochoa
Phone: 225-215-1353
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Baton Rouge, Louisiana 70805
Principal Investigator: Augusto C. Ochoa
Phone: 504-568-2428
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4950 Essen Lane
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Principal Investigator: Augusto C. Ochoa
Phone: 225-757-0343
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Beachwood, Ohio 44122
Principal Investigator: Min Yao
Phone: 800-641-2422
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Beaumont, Texas 77701
Principal Investigator: Ernest Hymel
Phone: 409-212-5956
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Beaver, Pennsylvania 15009
Principal Investigator: Liza C. Villaruz
Phone: 724-773-7616
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Bellingham, Washington 98225
Principal Investigator: Alison K. Conlin
Phone: 360-715-4133
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417
![Strecker Cancer Center-Belpre](/wp-content/uploads/logos/strecker-cancer-center-belpre.jpg)
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Bend, Oregon 97701
Principal Investigator: Alison K. Conlin
Phone: 541-706-2909
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
![Walter Reed National Military Medical Center](/wp-content/uploads/logos/walter-reed-national-military-medical-center.jpg)
Principal Investigator: Stephen L. Lewis
Phone: 773-702-9171
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bettendorf, Iowa 52722
Principal Investigator: David M. Spector
Phone: 563-359-9876
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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1233 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-237-7000
![Saint Vincent Healthcare](/wp-content/uploads/logos/saint-vincent-healthcare.png)
Principal Investigator: Keren Sturtz
Phone: 406-969-6060
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Birmingham, Alabama 35243
Principal Investigator: Michael C. Dobelbower
Phone: 205-934-0220
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Birmingham, Alabama 35233
Principal Investigator: Michael C. Dobelbower
Phone: 205-934-0220
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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Saint Alexius Medical Center St. Alexius Medical Center is a 306-bed, full-service, acute care medical...
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300 N. Seventh St.
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
(701) 323-6000
![Sanford Bismarck Medical Center](/wp-content/uploads/logos/sanford-bismarck-medical-center.jpg)
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102
![Illinois CancerCare-Bloomington](/wp-content/uploads/logos/illinois-cancercare-bloomington.gif)
Principal Investigator: Bryan A. Faller
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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Bloomington, Illinois 61701
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
![Saint Luke's Mountain States Tumor Institute](/wp-content/uploads/logos/saint-luke-s-mountain-states-tumor-institute.gif)
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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55 Fruit St
Boston, Massachusetts 02114
Boston, Massachusetts 02114
(617) 724-4000
![Massachusetts General Hospital Cancer Center](/wp-content/uploads/logos/massachusetts-general-hospital-cancer-center.jpg)
Principal Investigator: David E. Kozono
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
![Dana-Farber Cancer Institute](/wp-content/uploads/logos/dana-farber-cancer-institute.gif)
Principal Investigator: David E. Kozono
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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