Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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
Lung Cancer Other: clinical observation Radiation: radiation therapy Phase 2

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 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Arm I
Patients undergo observation for 6 weeks.
 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.
 Radiation: radiation therapy
Patients undergo radiotherapy 5 days a week for 6 weeks.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Show Show 168 study locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Steven E. Schild, MD Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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
Keywords provided by Alliance for Clinical Trials in Oncology:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
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