Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00863512

Recruitment Status : Terminated

First Posted : March 18, 2009

Results First Posted : March 27, 2017

Last Update Posted : March 27, 2017

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Alliance for Clinical Trials in Oncology

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: pemetrexed disodium Drug: vinorelbine tartrate Procedure: standard follow-up care	Phase 3

Detailed Description:

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	March 2009
Actual Primary Completion Date :	November 2011
Actual Study Completion Date :	November 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Lung cancer

MedlinePlus related topics: Lung Cancer

Genetic and Rare Diseases Information Center resources: Lung Adenocarcinoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: cisplatin Given IV Drug: docetaxel Given IV Drug: gemcitabine hydrochloride Given IV Drug: pemetrexed disodium Given IV Drug: vinorelbine tartrate Given IV
Experimental: Arm II Patients receive standard care (observation).	Procedure: standard follow-up care Standard care

Outcome Measures

Primary Outcome Measures :

Overall Survival [ Time Frame: Up to 12 years ]
Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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): NCT00863512

Show 94 Study Locations

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Investigators


Study Chair:	David H. Harpole, MD	Duke Cancer Institute

More Information


Responsible Party:	Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:	NCT00863512 History of Changes
Other Study ID Numbers:	CALGB-30506 CALGB-30506 CDR0000636895 ( Registry Identifier: NCI Physician Data Query )
First Posted:	March 18, 2009 Key Record Dates
Results First Posted:	March 27, 2017
Last Update Posted:	March 27, 2017
Last Verified:	February 2017

Keywords provided by Alliance for Clinical Trials in Oncology:


stage IA non-small cell lung cancer stage IB non-small cell lung cancer stage IIA non-small cell lung cancer adenocarcinoma of the lung	adenosquamous cell lung cancer bronchoalveolar cell lung cancer large cell lung cancer squamous cell lung cancer

Additional relevant 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 Gemcitabine Docetaxel Vinorelbine Cisplatin Pemetrexed	Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

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