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

April 9, 2009 updated by: University Hospital, Antwerp

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Antwerpen, Antwerp, Belgium, 2020
        • ZNA Middelheim
      • Edegem, Antwerp, Belgium, 2650
        • University Hospital Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • St Augustinus Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: at the end of each cycle and 5 year follow-up
at the end of each cycle and 5 year follow-up
Time to progression
Time Frame: 5 year follow-up
5 year follow-up
Overall survival
Time Frame: median survival and 2-year survival
median survival and 2-year survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Eli Lilly and Company
Universiteit Antwerpen

Investigators

  • Principal Investigator: Paul R Germonpre, MD PhD, Universiteit Antwerpen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 4, 2007

First Submitted That Met QC Criteria

July 4, 2007

First Posted (Estimate)

July 6, 2007

Study Record Updates

Last Update Posted (Estimate)

April 10, 2009

Last Update Submitted That Met QC Criteria

April 9, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOGA 0502
  • Eudra CT 2005-004030-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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