Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00776100 |
Recruitment Status :
Terminated
(Study was terminated prematurely due to slow accrual.)
First Posted : October 20, 2008
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
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Lung Cancer | Other: clinical observation Radiation: radiation therapy | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase II Study of Oligometastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) Treated With Systemic Therapy Plus Either Radiotherapy to All Sites of Gross Residual Disease or No Radiotherapy |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
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Arm I
Patients undergo observation for 6 weeks.
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Other: clinical observation
Patients undergo observation for 6 weeks. |
Experimental: Arm II
Patients undergo radiotherapy 5 days a week for 6 weeks to all sites of gross disease.
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Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week for 6 weeks. |
- Overall Survival [ Time Frame: Time from registration to death or last follow-up (up to 5 years) ]Overall survival was defined as the time from registration to the date of death or last follow-up
- Response Rate [ Time Frame: Up to 5 years ]A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.
- Progression-free Survival [ Time Frame: Time from registration to disease progression or death (up to 5 years) ]Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.
- Time to Disease Progression [ Time Frame: Time from registration to disease progression (up to 5 years) ]Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
- Time to Treatment Failure [ Time Frame: Up to 5 years ]Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.
- Duration of Response [ Time Frame: Up to 5 years ]Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Mixed histology allowed if all components are consistent with NSCLC
- Squamous cell histology allowed
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Stage IV disease
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Oligometastatic disease (M1 with 1-3 metastases)
- Patients with M1 disease that involves intrapulmonary metastases are eligible provided ≤ 40% of the total lung volume receives ≥ 20 Gy of radiotherapy
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- Previously untreated disease OR achieved stable disease or partial response within 8 weeks after completion of 2-6 courses of standard platinum-based chemotherapy (administered every 3-4 weeks)
- Pleural effusion allowed provided it is minimal
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No history of or current brain metastases
- Patients who have had up to 3 brain metastases allowed provided they have been treated with not signs of progression
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- Platelet count ≥ 100,00/mm^3
- Hemoglobin ≥ 9 g/dL
- WBC ≥ 2,000/mm^3
- Creatinine ≤ 2 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to undergo radiotherapy, based on radiation oncology consultation
- Willing and able to comply with study treatment
- FEV_1 ≥ 1 L
- No requirement for daily supplemental oxygen
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No second primary malignancy, except for any of the following:
- Carcinoma in situ of the cervix
- Nonmelanoma skin cancer
- History of low-grade (Gleason score ≤ 6) localized prostate cancer, even if diagnosed within the past 5 years
- Stage I breast cancer that was treated within the past 5 years
- Other malignancy that was diagnosed and definitely treated ≥ 5 years ago with no subsequent evidence of recurrence
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No concurrent severe and/or uncontrolled medical condition, including any of the following:
- Angina pectoris
- Congestive heart failure within the past 3 months, unless LVEF > 40%
- Myocardial infarction within the past 6 months
- Cardiac arrhythmia
- No clinically significant infection
- No psychiatric illness or social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior therapy for this cancer other than 2-6 courses of standard platinum-based chemotherapy with or without bevacizumab
- No prior radiotherapy to the treatment sites (e.g., primary lesion, clinically involved nodes, or metastatic lesions)
- No bevacizumab during and for 4 weeks after completion of radiotherapy
- No concurrent systemic chemotherapy
- No other maintenance systemic therapy during radiotherapy
- No other concurrent investigational agents for the primary neoplasm
- No concurrent intensity modulated radiotherapy
- No concurrent prophylactic nodal radiotherapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776100

Study Chair: | Steven E. Schild, MD | Mayo Clinic |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00776100 |
Other Study ID Numbers: |
NCCTG-N0724 NCI-2009-00664 ( Registry Identifier: CTRP (Clinical Trials Reporting System) ) CDR0000616868 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | October 20, 2008 Key Record Dates |
Results First Posted: | March 6, 2017 |
Last Update Posted: | March 6, 2017 |
Last Verified: | January 2017 |
stage IV non-small cell lung cancer adenosquamous cell lung cancer squamous cell lung cancer |
large cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |