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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

after each treatment modality and 5 year follow-up

Safety Issue:

No

Principal Investigator

Paul R Germonpre, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thoracic Oncology Group Antwerp

Authority:

Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:

TOGA 0502

NCT ID:

NCT00497315

Start Date:

February 2006

Completion Date:

March 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Chemoradiation
  • locally advanced NSCLC
  • pemetrexed
  • lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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