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

Conditions

• Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• cisplatin — DRUG
  50 mg/m2 IV
• vinorelbine ditartrate — DRUG
  25 mg/m2 IV

Study Details

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.

Key Dates

Start date

Jul 7, 1994

Status verified

Apr 2020

Primary completion

Apr 25, 2004

Completion

Dec 21, 2009

Study Design

Enrollment

482 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Observation
  Observation only
• Active Comparator: Chemotherapy
  Cisplatin and Vinorelbine

Primary Outcome Measure

survival [ Time Frame: At time of death ]

Locations (135)

Find similar trials in Birmingham, AL

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