Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Phase 2
Completed
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Drug: combination chemotherapy (pemetrexed + cisplatin)Radiation: thoracic irradiation + pemetrexed
- Registration Number
- NCT00497315
- Lead Sponsor
- University Hospital, Antwerp
- Brief Summary
The aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced NSCLC. Patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- cytological or histological proven NSCLC
- unresectable stage III NSCLC
- presence of at least one measurable lesion (RECIST criteria)
- adequate haematological, renal and hepatic function
- adequate lung function reserve
- good condition, weight loss <10 % over previous 6 months, life expectancy > 3 months
Exclusion Criteria
- previous chemo- or radiotherapy for NSCLC
- distant metastasis or a malignant pleural or pericardial effusion
- second active primary malignancy or serious concomitant medical disease
- interstitial lung disease
- auto-immune systemic disease with potential involvement of the lungs
- inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period
- concomitant use of amiodarone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A combination chemotherapy (pemetrexed + cisplatin) pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed A thoracic irradiation + pemetrexed pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed B combination chemotherapy (pemetrexed + cisplatin) thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin B thoracic irradiation + pemetrexed thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin
- Primary Outcome Measures
Name Time Method Response rate after each treatment modality and 5 year follow-up
- Secondary Outcome Measures
Name Time Method Toxicity at the end of each cycle and 5 year follow-up Time to progression 5 year follow-up Overall survival median survival and 2-year survival
Trial Locations
- Locations (3)
University Hospital Antwerp
🇧🇪Edegem, Antwerp, Belgium
St Augustinus Ziekenhuis
🇧🇪Wilrijk, Antwerp, Belgium
ZNA Middelheim
🇧🇪Antwerpen, Antwerp, Belgium