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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
combination chemotherapy (pemetrexed + cisplatin)
thoracic irradiation + pemetrexed
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, locally advanced NSCLC, pemetrexed, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ZNA Middelheim
  • University Hospital Antwerp
  • St Augustinus Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed

thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Toxicity
Time to progression
Overall survival

Full Information

First Posted
July 4, 2007
Last Updated
April 9, 2009
Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00497315
Brief Title
Evaluation of Pemetrexed Combined With Cisplatin and Radiotherapy for Unresectable Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Antwerp
Collaborators
Universiteit Antwerpen, Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Non-Small Cell Lung Cancer, NSCLC, Chemoradiation, locally advanced NSCLC, pemetrexed, lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
pemetrexed + cisplatin (3 cycles) followed by thoracic irradiation + pemetrexed
Arm Title
B
Arm Type
Experimental
Arm Description
thoracic irradiation + pemetrexed followed by pemetrexed + cisplatin
Intervention Type
Drug
Intervention Name(s)
combination chemotherapy (pemetrexed + cisplatin)
Other Intervention Name(s)
Alimta
Intervention Description
pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)
Intervention Type
Radiation
Intervention Name(s)
thoracic irradiation + pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)
Primary Outcome Measure Information:
Title
Response rate
Time Frame
after each treatment modality and 5 year follow-up
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
at the end of each cycle and 5 year follow-up
Title
Time to progression
Time Frame
5 year follow-up
Title
Overall survival
Time Frame
median survival and 2-year survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul R Germonpre, MD PhD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerpen
State/Province
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
St Augustinus Ziekenhuis
City
Wilrijk
State/Province
Antwerp
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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