We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497315
First Posted: July 6, 2007
Last Update Posted: April 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universiteit Antwerpen
Eli Lilly and Company
Information provided by:
University Hospital, Antwerp
  Purpose
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: 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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
  More Information

Responsible Party: Thoracic Oncology Group Antwerp - Paul Germonpre, Thoracic Oncology Group Antwerp
ClinicalTrials.gov Identifier: NCT00497315     History of Changes
Other Study ID Numbers: TOGA 0502
Eudra CT 2005-004030-40
First Submitted: July 4, 2007
First Posted: July 6, 2007
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:
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
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors