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NCT00002852 · CITED IN SOURCE DOCUMENTS

Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-07-03

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive no further therapy.
    intervention Names
    1. Procedure: therapeutic conventional surgery
    label
    Arm I (surgery, observation)
    type
    ACTIVE_COMPARATOR
  2. description
    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.
    intervention Names
    1. Drug: paclitaxel
    2. Drug: carboplatin
    3. Procedure: therapeutic conventional surgery
    label
    Arm II (surgery, chemotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (surgery, chemotherapy)
    description
    Given IV
    name
    paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. TAX
    4. Taxol
    type
    DRUG
  2. arm Group Labels
    1. Arm II (surgery, chemotherapy)
    description
    Given IV
    name
    carboplatin
    other Names
    1. Carboplat
    2. CBDCA
    3. JM-8
    4. Paraplat
    5. Paraplatin
    type
    DRUG
  3. arm Group Labels
    1. Arm I (surgery, observation)
    2. Arm II (surgery, chemotherapy)
    description
    Undergo surgery
    name
    therapeutic conventional surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
500
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Overall survival (OS)
    time Frame
    Up to 2.4 years
  2. description
    Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.
    measure
    Failure-free survival
    time Frame
    Time between randomization and disease relapse or death, assessed up to 2.4 years
secondary Outcomes
  1. measure
    Toxicity as assessed by Common Toxicity Criteria version 2.0
    time Frame
    Up to 1 year after completion of treatment
  2. description
    The frequency of local and distant relapse and the incidence of a second primary lung cancer will be tabulated by treatment.
    measure
    Pattern of disease recurrence.
    time Frame
    Up to 2 years
Full study description
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.
detailed Description
PRIMARY OBJECTIVES: I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer). SECONDARY OBJECTIVES: I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy. II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms. Arm I:Patients receive no further therapy. Arm II: 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. Patients are followed every 4 months for 2 years and then every 6 months thereafter.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        patients with stage IB NSCLC):</p> <div class="pdq-content-list"><ol id="_485815"><li>The Cancer and Leukemia Group B study (<a href="/clinicaltrials/NCT00002852">CALGB-9633</a> [NCT00002852]) addressed the results of adjuvant carboplatin and paclitaxel versus observation for OS in 344 patients with resected stage IB (
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        :</p> <div class="pdq-content-list"><ol id="_485815"><li>The Cancer and Leukemia Group B study (<a href="/clinicaltrials/NCT00002852">CALGB-9633</a> [NCT00002852]) addressed the results of adjuvant carboplatin and paclitaxel versus observation for OS in 344 patients with resected stage IB (i.e., pathological T2, N0) NS
        end
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        exact text
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        start
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      source file
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      source retrieved at
      2026-09-09T23:21:59.782436+00:00
      source string basis
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      source string sha256
      96af5062fe49c6481bdc1ef6946e69939f30c810b02e368845c837ccf6c0977c
      source title
      Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 15, 2025
        datetime
        2025-05-15T12:00:00Z
        display
        May 15, 2025

    Preserved source evidence · Not medical advice