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Status:

TERMINATED

Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief 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 suf...

Detailed 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 overa...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Mixed histology allowed if all components are consistent with NSCLC
  • Squamous cell histology allowed
  • Stage IV disease
  • 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
  • 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
  • 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
  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2010

    Estimated Enrollment :

    3 Patients enrolled

    Trial Details

    Trial ID

    NCT00776100

    Start Date

    October 1 2008

    End Date

    September 1 2010

    Last Update

    March 6 2017

    Active Locations (168)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 42 (168 locations)

    1

    Mayo Clinic Scottsdale

    Scottsdale, Arizona, United States, 85259-5499

    2

    Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, United States, 06105

    3

    Mayo Clinic - Jacksonville

    Jacksonville, Florida, United States, 32224

    4

    Illinois CancerCare - Bloomington

    Bloomington, Illinois, United States, 61701