NCT00193921

Chemoradiotherapy in Patients With Localised Lung Cancer

A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study compares 2 different methods of combined chemotherapy and radiotherapy for the treatment of localised lung cancer in patients not suitable for surgery. Hypothesis(es) to be tested: 1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting 2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting 3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine + high-dose palliative radiotherapy

Detailed description

A third of patients with non-small cell lung cancer (NSCLC) present with Stage IIIA or IIIB disease, which is not amenable to curative resection. Single modality local therapy, either surgery or radiation, only cures a fraction of such patients. Radical radiation is not feasible for all patients with unresectable Stage IIIA or IIIB non-small cell lung cancer, based upon the extent of the loco-regional disease or the medical state of the patient. Patients of good performance status receiving protracted high-dose palliative radiotherapy do obtain a survival benefit from this therapy. Studies have shown a survival advantage by adding chemotherapy to radical radiation therapy: but studies in the high-dose palliative radiotherapy setting are lacking. Two regimens of concurrent chemotherapy with high-dose palliative radiotherapy have been developed locally, with established MTDs. These 2 regimens do warrant a comparative assessment in a phase II trial, prior to a phase III trial against high dose palliative radiation alone (36Gy/12#/5). This is a randomised phase II trial comprising of 2 arms for randomization as follows: Arm A:External beam radiation, 40 Gy/20#/5 per week, Plus concurrent Vinorelbine, IV, 25mg/m2, days 1, 8, 22 and + Cisplatin 20mg/m2, IV, weekly Arm B:External beam radiation, 30 Gy/15#/5 per week, Plus concurrentGemcitabine, 200mg (flat dose) IV days 1, 8, 15 An equal number of patients will be randomised to each arm. The randomisation will be carried out by the Princess Alexandra Trial Centre. Patients will be assessed at baseline, weekly during treatment, and then at 3 weeks, 6 weeks and 12 weeks post treatment then 3 monthly thereafter.

Conditions

• Non Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Vinorelbine	IV, 25mg/m2, days 1, 8, 22
RADIATION	High dose Radiotherapy	External beam radiation, 40 Gy/20#/5 per week
DRUG	Gemcitabine	200mg (flat dose) IV days 1, 8, 15
DRUG	Cisplatin	20mg/m2, IV, weekly
RADIATION	High Dose Radiotherapy	External beam radiation, 30 Gy/15#/5 per week

Timeline

• Start date: 2003-02-01
• Primary completion: 2009-12-01
• Completion: 2012-12-01
• First posted: 2005-09-19
• Last updated: 2014-08-04

Locations

8 sites across 1 country: Australia