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Title Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

IRB RTOG0937

CC CC916

Hospital Fairview, Hillcrest, Independence, Main Campus, North Coast Cancer, Strongsville, Wooster

Stage N/A

Phase Phase 2

Disease Lung

Description

Primary Objective

• To determine the 1-year overall survival rate in patients with ED-SCLC with the administration of PCI alone versus PCI with consolidation extracranial RT following platinum based chemotherapy

Secondary Objectives

• To compare treatment-related adverse events;
• To evaluate patterns of failure;
• To compare the time to first failure;
• To evaluate the percentage of the planned radiation dose given to each site.

Inclusion Criteria

1. Pathologically (histologically or cytologically) proven diagnosis of extensive disease small cell lung cancer without brain metastases and with 1-4 metastatic lesions; Note: This does NOT include patients initially diagnosed with LD-SCLC who have progressed.
2. Patients must have completed 4-6 cycles of platinum-based chemotherapy.
3. Patients must be registered on study within 8 weeks of completing chemotherapy.
4. Prior to chemotherapy (at diagnosis), patients must have extensive stage disease with 1-4 extracranial metastatic lesions (no brain metastases). For example, the patient could have 2 lesions in the liver and 2 in the contralateral lung; or 1 in the bone, 1 in the contralateral lung, and 2 in the liver; or 3 liver lesions and 1 in the bone, etc. Lesion is not defined as "organ". The patient should have no clinical signs or symptoms of CNS metastases. Brain imaging is not
   required prior to chemotherapy if the patient is asymptomatic; however, brain imaging is
   required and must be negative for metastases prior to study entry. Extent of disease will be based on the following minimum diagnostic workup:
   • History/physical examination;
   • CT of the chest and abdomen with contrast or PET/CT.
5. After chemotherapy, patients will be restaged using the following diagnostic work up :
   • History/physical examination;
   • CT of the chest and abdomen with contrast (does not have to be done if the patient has had a PET/CT scan within 8 weeks prior to registration);
   • Bone scan (does not have to be done if the patient has had a PET scan within 8 weeks prior to registration);
   • MRI of the brain or CT with contrast of the brain, if MRI is contraindicated.
   Patients must have:
   • no CNS metastases;
   • radiographic partial or complete response to chemotherapy in a minimum of 1 site of disease using RECIST criteria (see Section 11.3.2); Note: if radiation has been delivered to primary disease with chemotherapy, there must be complete or partial response in at least 1 of the sites that has not been treated with radiation.
   • no progression in any site;
   • for the purposes of stratification, a response to treatment is only considered a “CR” if the patient has had a complete response in all sites of measurable disease.
6. Patients who have had thoracic radiation concurrently or prior to chemotherapy for the current diagnosis and meet all other eligibility criteria are eligible for the study but will not receive mediastinal radiation per protocol.
   • Measurements for all pre- and post-chemotherapy measurable disease must be submitted.
7. Zubrod Performance Status 0-2;
8. Age ≥ 18;
9. For patients who will be treated with radiation to the liver, adequate hepatic function, defined as follows:
   • Serum ALT and AST within 2.5 X ULN within 1 week prior to registration;
   • Serum bilirubin < 1.5 X ULN within 1 week prior to registration.
10. For patients who will be treated with radiation to the kidneys, adequate renal function defined as a serum creatinine < 1.5 X ULN within 1 week of registration;
11. CBC/differential obtained within 1 week prior to registration, with adequate bone marrow function defined as follows:
    • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm³;
    • Platelets ≥ 75,000 cells/mm³;
    • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.).
12. For women of childbearing potential, a negative serum pregnancy test within 1 week of registration;
13. All toxicities related to chemotherapy must be resolved to < grade 1 prior to initiation of study therapy (with the exception of neuropathy and alopecia, which may take a longer period to recover). Laboratory abnormalities, with the exception of those specified in Sections 3.1.9, 3.1.10, and 3.1.11, are allowed if they are not deemed clinically significant.
14. Patients must provide study-specific informed consent prior to study entry.

Exclusion Criteria

1. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields (see Section 3.1.6 for exception);
2. Limited stage disease at diagnosis;
3. Central nervous metastases;
4. Severe, active co-morbidity, defined as follows:
   • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
   • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
5. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.