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

Non-Small Cell Lung Cancer Clinical Trial

— PACCORA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497315
• Other study ID #: TOGA 0502
• Secondary ID: Eudra CT 2005-00
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2007
• Last updated: April 9, 2009
• Start date: February 2006
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• combination chemotherapy (pemetrexed + cisplatin)
pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)

Radiation:
• thoracic irradiation + pemetrexed
pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen	Antwerp
Belgium	University Hospital Antwerp	Edegem	Antwerp
Belgium	St Augustinus Ziekenhuis	Wilrijk	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Eli Lilly and Company, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		after each treatment modality and 5 year follow-up	No
Secondary	Toxicity		at the end of each cycle and 5 year follow-up	Yes
Secondary	Time to progression		5 year follow-up	No
Secondary	Overall survival		median survival and 2-year survival	No