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

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Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2009
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00776100

Purpose
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 Intervention Phase
Lung Cancer
Procedure: observation
Radiation: radiation therapy
Phase II




MedlinePlus related topics: Cancer Lung Cancer Radiation Therapy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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 Disease or No Radiotherapy


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Overall survival [ Designated as safety issue: No ]



Secondary Outcome Measures:
Response rate [ Designated as safety issue: No ]

Progression-free survival [ Designated as safety issue: No ]

Time to disease progression [ Designated as safety issue: No ]

Time to treatment failure [ Designated as safety issue: No ]

Duration of response [ Designated as safety issue: No ]

Adverse events [ Designated as safety issue: Yes ]


Estimated Enrollment: 98
Study Start Date: October 2008
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: No Intervention
Patients undergo observation for 6 weeks. Procedure: observation
Patients undergo observation for 6 weeks.
Arm II: Experimental
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.


Detailed Description:
OBJECTIVES:

Primary

To assess whether the addition of radiotherapy 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), and Linear Analog Self Assessment value (≤ 7 vs > 7). 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.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
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
Achieved stable disease, partial response, or complete 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
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 concurrent investigational agents for the primary neoplasm
No concurrent intensity modulated radiotherapy
No concurrent prophylactic nodal radiotherapy
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776100

Show 94 Study Locations

Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Investigators
Study Chair: Steven E. Schild, MD Mayo Clinic Scottsdale
Investigator: George T. Henning, MD Saint Joseph Mercy Cancer Center
Investigator: Yolanda I. Garces, MD Mayo Clinic
Investigator: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
Investigator: Philip J. Stella, MD Ann Arbor Hematology Oncology Associates, PC at St. Joseph Mercy Cancer Center

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000616868, NCCTG-N0724
Study First Received: October 17, 2008
Last Updated: February 4, 2009
ClinicalTrials.gov Identifier: NCT00776100 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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