Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Sometimes, after chemotherapy, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation after chemotherapy in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared with observation after chemotherapy in treating patients with stage IV non-small cell lung cancer.
Description
OBJECTIVES:
Primary
- To assess whether the addition of radiotherapy to radiographically apparent residual disease after an initial course of standard chemotherapy results in an improvement in overall survival of patients with oligometastatic stage IV non-small cell lung cancer.
Secondary
- To compare the progression-free survival of patients treated with radiotherapy vs observation after standard chemotherapy.
- To compare the time to disease progression and time to treatment failure in these patients.
- To compare the confirmed response rate in these patients.
- To compare the duration of response in these patients.
- To compare the adverse events in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with bevacizumab during first-line chemotherapy (yes vs no), number of standard chemotherapy courses (2-3 vs 4-6), Linear Analog Self Assessment value (≤ 7 vs > 7), and histology (predominantly squamous cell vs not predominantly squamous cell). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo observation for 6 weeks.
- Arm II: Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
After completion of study therapy, patients are followed every 3-6 months for up to 5 years.
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Conditions
Lung Cancer
Intervention
clinical observation, radiation therapy
Location
Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00776100
- Information obtained from ClinicalTrials.gov on July 15, 2012
Medical and Biotech [MESH] Definitions
Neoadjuvant Therapy
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Chemotherapy, Adjuvant
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Carcinoma, Bronchogenic
Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.
Watchful Waiting
Clinical management approach wherein immediate therapy is not provided but there is a period of observation during which periodic tests monitor patient and the progression of the illness. (Driffield T, Smith PC Med Decis Making. 2007 Mar-Apr;27(2):178-88)
Organs At Risk
Organs which might be damaged during exposure to a toxin or to some form of therapy. It most frequently refers to healthy organs located in the radiation field during radiation therapy.
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