A prospective randomized study of adjuvant chemotherapy with navelbine and cisplatin in completely resected non small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95053737

Enrollment

840

Registered

2006-03-22

Start date

1994-12-06

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non small cell lung cancer Cancer Non small cell lung cancer

Interventions

Chemotherapy with navelbine and cisplatin versus best supportive care.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven primary non small cell lung cancer (NSCLC) (except bronchoalveolar carcinoma) stage I (T2N0 only), II, and IIIA according to the 1986 TNM classification 2. Complete resection of the primary tumor (all margins free of disease) 3. Age 18-75 years 4. World Health Organization (WHO) performance status =2 5. Adequate biological functions

Exclusion criteria

Exclusion criteria: 1. Patients with a history of concurrent malignancy (except adequately treated non-melanoma skin cancer or in situ cervical cancer) 2. Previous treatment with adjuvant therapy

Design outcomes

Primary

Measure	Time frame
Primary endpoint is overall survival, one-sided test, alpha = 0.05, beta = 0.10, delta = 10%, anticipated two-year survival rate is 30%, benefit expected is an absolute improvement of 10% in the two-year survival rate.	—

Secondary

Measure	Time frame
1. To determine disease-free survival 2. To evaluate toxicity related to chemotherapy	—

Countries

Argentina, Austria, Brazil, Czech Republic, France, Greece, Italy, Lebanon, Poland, Portugal, Slovakia, South Africa, Spain, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 11, 2026