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

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ClinicalTrials.gov Identifier: NCT00497315
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : April 10, 2009
Sponsor:
Collaborators:
Universiteit Antwerpen
Eli Lilly and Company
Information provided by:
University Hospital, Antwerp

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: combination chemotherapy (pemetrexed + cisplatin) Radiation: thoracic irradiation + pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed
 Drug: combination chemotherapy (pemetrexed + cisplatin)
pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
Other Name: Alimta

Radiation: thoracic irradiation + pemetrexed
pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)
Other Name: Alimta
Experimental: B
thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin
 Drug: combination chemotherapy (pemetrexed + cisplatin)
pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
Other Name: Alimta

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


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: after each treatment modality and 5 year follow-up ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: at the end of each cycle and 5 year follow-up ]
  2. Time to progression [ Time Frame: 5 year follow-up ]
  3. Overall survival [ Time Frame: median survival and 2-year survival ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497315


Locations
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Belgium
ZNA Middelheim
Antwerpen, Antwerp, Belgium, 2020
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
St Augustinus Ziekenhuis
Wilrijk, Antwerp, Belgium, 2610
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Eli Lilly and Company
Investigators
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Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
More Information
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Responsible Party: Thoracic Oncology Group Antwerp - Paul Germonpre, Thoracic Oncology Group Antwerp
ClinicalTrials.gov Identifier: NCT00497315    
Other Study ID Numbers: TOGA 0502
Eudra CT 2005-004030-40
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: April 10, 2009
Last Verified: April 2009
Keywords provided by University Hospital, Antwerp:
Non-Small Cell Lung Cancer
NSCLC
Chemoradiation
 locally advanced NSCLC
pemetrexed
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors