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

This study has been completed.
Universiteit Antwerpen
Eli Lilly and Company
Information provided by:
University Hospital, Antwerp Identifier:
First received: July 4, 2007
Last updated: April 9, 2009
Last verified: April 2009
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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: combination chemotherapy (pemetrexed + cisplatin)
Radiation: thoracic irradiation + pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University Hospital, Antwerp:

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

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

Enrollment: 30
Study Start Date: February 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00497315

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
Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
  More Information

Responsible Party: Thoracic Oncology Group Antwerp - Paul Germonpre, Thoracic Oncology Group Antwerp Identifier: NCT00497315     History of Changes
Other Study ID Numbers: TOGA 0502
Eudra CT 2005-004030-40
Study First Received: July 4, 2007
Last Updated: April 9, 2009

Keywords provided by University Hospital, Antwerp:
Non-Small Cell Lung Cancer
locally advanced NSCLC
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on April 26, 2017