Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Radiation: Radiation Therapy; Radiation: Prophylactic Cranial Irradiation

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT01055197

NCI-2011-02008 (Registry Identifier)

RTOG 0937

CDR0000663959

Details and patient eligibility

About

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.

PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.

Full description

OBJECTIVES:

Primary

• To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy.

Secondary

• To compare treatment-related adverse events in these patients.
• To evaluate patterns of failure in these patients.
• To compare the time to first failure in these patients.
• To evaluate the percentage of the planned radiotherapy dose given to each site.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.
• Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks.

After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) diagnosed within the past 6 months*

  • Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment with chemotherapy

• Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND meets the following criteria:

  • Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (if radiotherapy has been delivered to primary disease with chemotherapy, there must be complete or partial response in ≥ 1 of the sites that has not been treated with radiotherapy)
  • No progression in any site

• No limited stage SCLC, even if disease progressed

• No brain or central nervous system (CNS) metastases

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2

• Absolute neutrophil count (ANC) ≥ 1,000/mm^3

• Platelets ≥ 75,000/mm^3

• Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)

• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver)

• Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the liver)

• Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the kidneys)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No severe, active co-morbidity, defined as any of the following:

  • Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study registration

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy and alopecia])
• Thoracic radiotherapy administered concurrently with or before chemotherapy for the current diagnosis allowed (these patients will not receive mediastinal radiotherapy per protocol)
• No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
• No concurrent chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

PCI

Experimental group

Description:

Prophylactic Cranial Irradiation (PCI)

Treatment:

Radiation: Prophylactic Cranial Irradiation

PCI + Consolidation RT

Experimental group

Description:

Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease

Treatment:

Radiation: Prophylactic Cranial Irradiation

Radiation: Radiation Therapy