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Chemoradiotherapy in Patients With Localised Lung Cancer

NCT00193921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2014-08-04

No results posted yet for this study

Summary

The study compares 2 different methods of combined chemotherapy and radiotherapy for the treatment of localised lung cancer in patients not suitable for surgery.

Hypothesis(es) to be tested:

1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting
2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting
3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine + high-dose palliative radiotherapy

Conditions

  • Non Small Cell Lung Carcinoma

Interventions

DRUG

Vinorelbine

IV, 25mg/m2, days 1, 8, 22

RADIATION

High dose Radiotherapy

External beam radiation, 40 Gy/20#/5 per week

DRUG

Gemcitabine

200mg (flat dose) IV days 1, 8, 15

DRUG

Cisplatin

20mg/m2, IV, weekly

RADIATION

High Dose Radiotherapy

External beam radiation, 30 Gy/15#/5 per week

Sponsors & Collaborators

  • Cancer Council Queensland

    collaborator OTHER

  • Victorian Cancer Council

    collaborator UNKNOWN

  • Trans Tasman Radiation Oncology Group

    lead OTHER

Principal Investigators

  • Michael Michael · Peter MacCallum Cancer Centre, Australia

  • Bryan Burmeister · Princess Alexandra Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2009-12-31
Completion
2012-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT00193921 on ClinicalTrials.gov