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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR924
• Date of registration: 05/03/2007
• Primary sponsor: NVALT
• Public title: Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small lung cancer (NSCLC) of any stage.
• Scientific title: Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small lung cancer (NSCLC) of any stage. - Pre-operative chemotherapy.
• Date of first enrolment: 17/7/2001
• Target sample size: 519
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=924
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: E.F. Smit

• Name: H.J.M. Groen

Key inclusion & exclusion 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: See inclusion criteria.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Non small cell lung cancer (NSCLC)

Intervention(s)

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 will be administered before surgery. Cycles are repeated every 3 weeks. Cisplatin is administered after gemcitabine 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.

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Eli Lilly Nederland B.V., Asta Medica, The Netherlands, Aventis Pharma, The Netherlands

Secondary Sponsor(s)

MRC Trial Organisation