Suspended

Adjuvant Treatment of Non Small Cell Lung Cancer

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What is being tested

cisplatin

+ etoposide

+ adjuvant therapy

DrugProcedure
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Until 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 1994
See protocol details

Summary

Principal SponsorEuropean Institute of Oncology
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1994

Actual date on which the first participant was enrolled.

OBJECTIVES: Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I, II, and IIIA non-small cell lung cancer. OUTLINE: This a randomized study (treatment vs no treatment). Patients are stratified according to sex and to stage of disease (I vs II vs IIIA). Patient receives cisplatin and etoposide on days 1-3, every 28 days, for 3 cycles. Patient may receive radiation therapy after surgery at the discretion of the physician. PROJECTED ACCRUAL: Approximately 750 patients will be accrued over 3 years.

NCT00003053
Principal SponsorEuropean Institute of Oncology
Last updated: September 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

750 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell LungLung Neoplasms

Criteria

DISEASE CHARACTERISTICS: Histologically proven stage I, II, or IIIA non-small cell lung cancer after radical surgery No evidence of lymphonodal enlargement during postsurgical chest CT scan PATIENT CHARACTERISTICS: Age: 70 and under Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 times the upper limit of normal Pulmonary: FEV1 at least 1 liter Other: Less than 10% weight loss in the past 3 months No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Radical surgery required

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 86 locations

George Papanicolaou General Hospital

Thessaloniki, GreeceOpen George Papanicolaou General Hospital in Google Maps

Ospedale Bassini

Balsamo Cinisello, Italy

Universita Degli Studi di Bari Policlinico

Bari, Italy

Spedali Civili

Brescia, Italy
Suspended86 Study Centers