Enrollment complete
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
NCT No.: NCT00632853
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym:
Official Title
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
Purpose
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide 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.
Detailed Description
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.
Age Limit
18 years & older
Eligibility Criteria
Inclusion Criteria
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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
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Exclusion Criteria
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Please contact the study team for exclusion criteria.
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Keywords and/or Specific Medical Conditions
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Antineoplastic Agents, Phytogenic
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Physiological Effects of Drugs
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Radiation-Sensitizing Agents
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Respiratory Tract Diseases
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Respiratory Tract Neoplasms
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Small Cell Lung Carcinoma
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Sponsors
- Alliance for Clinical Trials in Oncology
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- Cancer and Leukemia Group B
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- Eastern Cooperative Oncology Group
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- National Cancer Institute (NCI)
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- North Central Cancer Treatment Group
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- Radiation Therapy Oncology Group
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