NCT00002852

Brief Summary

Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

7.8 years

First QC Date

November 1, 1999

Last Update Submit

July 2, 2013

Conditions

Adenocarcinoma of the LungAdenosquamous Cell Lung CancerBronchoalveolar Cell Lung CancerLarge Cell Lung CancerSquamous Cell Lung CancerStage IB Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Overall survival (OS)

    OS curves will be calculated using the Kaplan-Meier life-table method. Comparison of the survival curve for the two treatment regimens will be performed using the log-rank test for censored data.

    Up to 2.4 years

  • Failure-free survival

    Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.

    Time between randomization and disease relapse or death, assessed up to 2.4 years

Secondary Outcomes (2)

  • Toxicity as assessed by Common Toxicity Criteria version 2.0

    Up to 1 year after completion of treatment

  • Pattern of disease recurrence.

    Up to 2 years

Study Arms (2)

Arm I (surgery, observation)

ACTIVE COMPARATOR

Patients receive no further therapy.

Procedure: therapeutic conventional surgery

Arm II (surgery, chemotherapy)

EXPERIMENTAL

Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.

Drug: paclitaxelDrug: carboplatinProcedure: therapeutic conventional surgery

Interventions

paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Arm II (surgery, chemotherapy)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Arm II (surgery, chemotherapy)
therapeutic conventional surgeryPROCEDURE

Undergo surgery

Arm I (surgery, observation)Arm II (surgery, chemotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented non-small cell carcinoma
  • Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System
  • Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy)
  • Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection
  • No prior chemotherapy or radiation for non-small cell lung cancer
  • Performance status of 0 or 1
  • Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
  • Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years
  • Granulocytes \>= 1,800/ul
  • Platelets \>= 100,000/ul
  • Bilirubin \< 1.5 mg/dl
  • SGOT (AST) \< 2.0 x ULN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of LungAdenocarcinoma, Bronchiolo-AlveolarCarcinoma, Non-Small-Cell Lung

Interventions

PaclitaxelTaxesCarboplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteCarcinoma, BronchogenicBronchial NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsCoordination Complexes

Study Officials

  • Gary Strauss

    Cancer and Leukemia Group B

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

October 1, 1996

Primary Completion

July 1, 2004

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

US(1)