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Clinical Trial 19077

Cancer Type:
Interventions:Paraplatin (carboplatin); carboplatin; cisplatin; etoposide

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Thomas Dilling

Overview

Study Title

Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin or Carboplatin and Etoposide

Summary

The purpose of this study is to compare the effects, good and/or bad, of two different ways to give radiation therapy. One of the ways is experimental, while one of them is standard. The experimental way of giving the radiation therapy is once a day with a high dose of radiation for 7 weeks. The standard way of giving the radiation therapy is to give it twice a day for 3 weeks.

Objective

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.

Inclusion Criteria

  • 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
  • Participants 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: 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. No prior mediastinal or thoracic radiotherapy. Additional criteria may apply.
  • Age Requirement ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Not pregnant or nursing
  • Meet Required Initial Laboratory Values

    • Exclusion Criteria

  • Patients with complete surgical resection of disease are not eligible
  • Patients with complete surgical resection of disease are not eligible
  • 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

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