Phase 2 N=97 Randomized Treatment

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

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01055197 ↗

Enrolled (actual)

Serious AEs

8.1%

Results posted

Oct 2016

Primary outcome: Primary: Overall Survival (12-month Rate Reported) — 60.1; 50.8 percentage of participants — p=0.2103

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Prophylactic Cranial Irradiation (Radiation); Radiation Therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Radiation Therapy Oncology Group
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival (12-month Rate Reported)	60.1; 50.8	0.2103
SECONDARY Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event	24; 36	0.24
SECONDARY Patterns of Failure - Number of Patients With Failure by Site	25; 13; 20; 8; 0; 6	—
SECONDARY First Failure (12-month Rate Reported)	79.6; 75.0	0.0102 sig
SECONDARY Percentage of Planned Radiotherapy Dose (All Sites) That Was Delivered	100; 100	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01055197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.