Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Multicenter Phase II Study Of Induction Therapy With Pemetrexed And Cisplatin Followed By Chemoradiation With Pemetrexed Versus Chemoradiation With Pemetrexed Followed By Consolidation Therapy With Pemetrexed And Cisplatin In Patients With Stage III Non-Small Cell Lung Cancer: Paccora Trial

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: combination chemotherapy (pemetrexed + cisplatin)
* Radiation: thoracic irradiation + pemetrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed | Drug: combination chemotherapy (pemetrexed + cisplatin)<br>* pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)<br>* Other names: Alimta;Radiation: thoracic irradiation + pemetrexed<br>* pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)<br>* Other names: Alimta;|
| Experimental: B<br>thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin | Drug: combination chemotherapy (pemetrexed + cisplatin)<br>* pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)<br>* Other names: Alimta;Radiation: thoracic irradiation + pemetrexed<br>* pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)<br>* Other names: Alimta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | after each treatment modality and 5 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, locally advanced NSCLC, pemetrexed, lung cancer