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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00863512




Registration number
NCT00863512
Ethics application status
Date submitted
17/03/2009
Date registered
17/03/2009
Date last updated
7/02/2017

Titles & IDs
Public title
Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
CALGB-30506
Secondary ID [2] 0 0
CALGB-30506
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cisplatin
Treatment: Drugs - docetaxel
Treatment: Drugs - gemcitabine hydrochloride
Treatment: Drugs - pemetrexed disodium
Treatment: Drugs - vinorelbine tartrate
Treatment: Surgery - standard follow-up 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.

Experimental: Arm II - Patients receive standard care (observation).


Treatment: Drugs: cisplatin
Given IV

Treatment: Drugs: docetaxel
Given IV

Treatment: Drugs: gemcitabine hydrochloride
Given IV

Treatment: Drugs: pemetrexed disodium
Given IV

Treatment: Drugs: vinorelbine tartrate
Given IV

Treatment: Surgery: standard follow-up care
Standard care

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - 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.
Timepoint [1] 0 0
Up to 12 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
Alliance for Clinical Trials in Oncology
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00863512
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David H. Harpole, MD
Address 0 0
Duke Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00863512