Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Standard Radiation Dose Therapy; cisplatin; etoposide; High Radiation Dose Therapy; carboplatin
Intervention description: 45 Gy; IV; IV; 70 Gy; IV
Intervention MeSH terms: Carboplatin; Etoposide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 731.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: limited stage small cell lung cancer

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, 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.
    

Eligibility criteria:

        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