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Trial record 1 of 1 for:    CALGB 30506
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Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00863512
First received: March 17, 2009
Last updated: December 13, 2011
Last verified: December 2011

March 17, 2009
December 13, 2011
March 2009
January 2014   (final data collection date for primary outcome measure)
Overall survival [ Designated as safety issue: No ]
Overall survival at 5 years [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00863512 on ClinicalTrials.gov Archive Site
Not Provided
Cancer-free survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.

OBJECTIVES:

Primary

  • To determine the potential overall survival benefit of adjuvant chemotherapy in patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy compared to those randomized to the present standard of care (observation).
  • To collect and process high-quality fresh frozen lung cancer tumor tissue for gene expression array generation from multiple institutions.

Secondary

  • To evaluate selected genomic-based lung cancer prognostic models using data from the patients randomized to observation after resection.
  • To characterize the rate of chemotherapy toxicity for the different chemotherapy treatment regimens.
  • To assess quality of life (QOL) in early stage patients periodically after resection for NSCLC.
  • To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as compared to patients in the observation arm.

OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms within 12 weeks after surgery.

All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy, bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection).

  • Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

    • Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1.
    • Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1.
    • Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1.
    • Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1.
  • Arm II: Patients receive standard care (observation). Tissue obtained at surgery is examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each patient and correlated with survival and response.

After completion of study treatment, patients are followed every 6 months for 5 years and then once a year for 7 years.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin
    Given IV
  • Drug: docetaxel
    Given IV
  • Drug: gemcitabine hydrochloride
    Given IV
  • Drug: pemetrexed disodium
    Given IV
  • Drug: vinorelbine tartrate
    Given IV
  • Procedure: standard follow-up care
    Standard care
  • Experimental: Arm I
    Patients receive cisplatin IV on day 1 and vinorelbine ditartrate IV on days 1 and 8 OR docetaxel IV and cytarabine IV on day 1 OR gemcitabine hydrochloride IV on days 1 and 8 and cytarabine IV on day 1 OR pemetrexed disodium IV and cisplatin IV on day 1.. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: cisplatin
    • Drug: docetaxel
    • Drug: gemcitabine hydrochloride
    • Drug: pemetrexed disodium
    • Drug: vinorelbine tartrate
  • Experimental: Arm II
    Patients receive standard care (observation).
    Intervention: Procedure: standard follow-up care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1620
Not Provided
January 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or adenosquamous cell carcinoma)
    • Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0
    • No status
  • Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan

    • The mass must have a source document to verify tumor size in the greatest dimension, which includes a CT scan report, a clinic note from the enrolling physician, and/or a printed image with caliper measurements on the lung mass
  • Node-negative disease

    • Evidence of hilar or mediastinal node involvement by chest CT scan (> 1 cm diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling before or at time of thoracotomy
  • No locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Granulocytes ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Bilirubin ≤ 1.5 mg/dL
  • AST < 1.5 times upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No history of prior or concurrent malignancy, except curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

  • More than 3 years since prior cytotoxic or anticancer treatment
  • No concurrent treatment with hormones or other chemotherapeutic agents, except steroids given for adrenal failure, hormone administered for nondisease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic
  • No concurrent thoracic radiotherapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00863512
CDR0000636895, CALGB-30506
Not Provided
Monica M. Bertagnolli, Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: David H. Harpole, MD Duke Cancer Institute
National Cancer Institute (NCI)
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP