Status:
UNKNOWN
Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, eithe...
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 per...
Eligibility Criteria
Inclusion
- Documentation of Disease
- Histologically or cytologically documented small cell lung cancer (SCLC)
- 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
- 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
- Prior Treatment
- 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.
- 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.
- Additionally, these patients also must have met all of the eligibility criteria in the protocol prior to receiving the first cycle of chemotherapy.
- Registration to CALGB 30610 must take place within 14-21 days after the start of the non-protocol therapy.
- Failing to do all of the above will make the patient NOT eligible for CALGB 30610.
- No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC
- No prior mediastinal or thoracic radiotherapy
- Patients with complete surgical resection of disease are not eligible
- Age Requirement ≥ 18 years of age
- ECOG Performance Status 0-2
- Non-pregnant and non-nursing - No patients that are known to be pregnant or nursing
- Required Initial Laboratory Values
- Granulocytes ≥ 1,500/µl
- Platelet count ≥ 100,000/µl
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST (SGOT) ≤ 2.0 times ULN
- Serum creatinine ≤ 1.5 times ULN OR Calculated creatinine clearance ≥ 70 mL/min
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
731 Patients enrolled
Trial Details
Trial ID
NCT00632853
Start Date
March 1 2008
Last Update
June 12 2023
Active Locations (934)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35243
3
Providence Hospital
Mobile, Alabama, United States, 36608
4
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States, 98508