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

NCT00497315 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-04-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

combination chemotherapy (pemetrexed + cisplatin)

pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (q 3 weeks for 3 cycles)

RADIATION

thoracic irradiation + pemetrexed

pemetrexed 500 mg/m2 (q 3weeks for 2 cycles), 60 GY (30 fractions of 2 GY)

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • Eli Lilly and Company

    collaborator INDUSTRY

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Paul R Germonpre, MD PhD · Universiteit Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Belgium

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00497315 on ClinicalTrials.gov