Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small lung cancer (NSCLC) of any stage.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27849

Enrollment

519

Registered

2007-03-05

Start date

2001-07-17

Completion date

Unknown

Last updated

2024-02-28

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 (NSCLC)

Interventions

Chemotherapy for EORTC and NVALT participants: each center should choose only one schedule: 1. Three cycles of chemotherapy with gemcitabine 1250 mg/m² on days 1 and 8 and cisplatin 80 mg/m² on day 1

2. Three cycles of chemotherapy with docetaxel 75 mg/m² and carboplatin AUC= 6 will be used on day 1 every 3 weeks before surgery starts.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Previously untreated, microscopically proven NSCLC diagnosed at the local centre from biopsy or cytology; 2. Tumour considered resectable by the surgeon; 3. Either sex, any age; 4. No evidence of distant metastases; 5. Considered fit for chemotherapy and proposed surgical resection; 6. WHO performance status 0, 1 or 2, namely: ambulatory and capable of all self-care and up and about more than 50% of waking hours, whether or not able to work (WHO, 1979); 7. No contraindication to chemotherapy or surgery; 8. No other disease or previous malignancy likely to interfere with the protocol treatments or comparisons; 9. Patient willing and able to complete SF-36 QL questionnaires; 10. Informed consent obtained; 11. First SF-36 questionnaire completed.

Exclusion criteria

Exclusion criteria: See inclusion criteria.

Design outcomes

Primary

Measure	Time frame
The primary aim is the 3-year survival rate after surgical resection with or without pre-operative chemotherapy.	—

Secondary

Measure	Time frame
1. Quality of life throughout the survival period; all items on the SF-36 questionnaire will be used to assess physical, emotional and functional health status, with particular emphasis on items that reflect the impact of symptoms on activities; 2. Pre-randomisation clinical and post-surgery pathological staging; 3. Resectability rates; 4. Extent of surgery; 5. Time to and site of relapse. And in the chemotherapy group, to document: a. response according to recist (1999) criteria, and; b. clinician’s assessment of the adverse effects of chemotherapy.	—

Measure

Time frame

1. Quality of life throughout the survival period; all items on the SF-36 questionnaire will be used to assess physical, emotional and functional health status, with particular emphasis on items that reflect the impact of symptoms on activities; 2. Pre-randomisation clinical and post-surgery pathological staging; 3. Resectability rates; 4. Extent of surgery; 5. Time to and site of relapse. And in the chemotherapy group, to document: a. response according to recist (1999) criteria, and; b. clinician’s assessment of the adverse effects of chemotherapy.

—

Contacts

Public ContactE.F. Smit

Department of Pulmonary Diseases VU University Medical Centre PO Box 7057

ef.smit@vumc.nl+31 (0)20 4444782

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)