CompletedPhase 3NCT00002583
Official study title

Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is more effective than no further treatment for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus cisplatin with that of no further therapy in treating patients who have stage I or stage II non-small cell lung cancer that has been completely removed during surgery.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcisplatin and vinorelbine ditartrate

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 3, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?155 U.S. locations

Locations may change over time.

Who runs it?NCIC Clinical Trials Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
NCIC Clinical Trials Group
Interventions being studied
Drug: cisplatin; Drug: vinorelbine ditartrate
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed primary non-small cell lung cancer that is completely resected No mixed small and non-small cell histologies Pathologic T2 N0 or T1-2 N1 T1 N1 and T2 N1 only for CALGB institutions Removal of all gross disease with negative resection margins by lobectomy, sleeve resection, bilobectomy, or pneumonectomy (based on intraoperative findings) No segmentectomy or wedge resection Complete mediastinal lymph node resection or sampling required at primary tumor resection, with minimum levels of nodal sampling as follows: Primary in right upper lobe - levels 4, 7, 10 Primary in right middle lobe - levels 4, 7, 10 Primary in right lower lobe - levels 4, 7, 9, 10 Primary in left upper lobe - levels 5, 6, 7, 10 Primary in left lower lobe - levels 7, 9, 10 If complete mediastinal lymph node resection has not been undertaken, any mediastinal lymph node which measured 1.5 cm or more on presurgical CT scan must have been biopsied and found to be free of metastatic involvement Disease at nodal station 10 (tracheobronchial angle) is considered N2 disease for this trial and is not eligible No more than one discrete primary tumor No bronchoalveolar carcinoma with lobar or multilobar involvement Discrete solitary radiological mass or nodule eligible Snap frozen fresh primary tumor tissue must be submitted to Lung Cancer Tumor Bank within 14 days after surgery by selected Canadian centers Others to submit representative paraffin block within 2 months of surgery PATIENT CHARACTERISTICS: Age: 18 and over (lower age limit determined by individual center) Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin no greater than 1.25 times normal AST/ALT no greater than 1.25 times normal Alkaline phosphatase no greater than 1.25 times normal Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No history of congestive heart failure or other cardiac abnormality that may preclude hydration necessary for cisplatin administration Other: No active pathologic condition that would preclude study No active uncontrolled infection No history of psychiatric or neurologic disorder that would preclude study No prior breast cancer, melanoma, or hypernephroma No other malignancy within the past 5 years except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Ability to tolerate treatment (based on consultation between the thoracic surgeon and a medical oncologist or hematologist) and available for follow-up PRIOR CONCURRENT THERAPY: Complete resection required Randomization between 28 and 40 days after surgery required

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Veterans Affairs Medical Center - BirminghamBirmingham, Alabama
  • MBCCOP - University of South AlabamaMobile, Alabama
  • CCOP - Greater PhoenixPhoenix, Arizona
  • Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona
  • Veterans Affairs Medical Center - TucsonTucson, Arizona
  • Arizona Cancer CenterTucson, Arizona
  • University of Arkansas for Medical SciencesLittle Rock, Arkansas
  • Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas
  • University of California San Diego Cancer CenterLa Jolla, California
  • Veterans Affairs Medical Center - Long BeachLong Beach, California
  • USC/Norris Comprehensive Cancer CenterLos Angeles, California
  • Jonsson Comprehensive Cancer Center, UCLALos Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 3, 2020. Always confirm current availability with the study team.

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