Status:
COMPLETED
Chemoradiotherapy in Patients With Localised Lung Cancer
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Cancer Council Queensland
Victorian Cancer Council
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Vino...
Detailed Description
A third of patients with non-small cell lung cancer (NSCLC) present with Stage IIIA or IIIB disease, which is not amenable to curative resection. Single modality local therapy, either surgery or radia...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven non-small cell lung cancer.
- Planned high dose palliative radiation therapy for locoregional control. Examples include patients with:
- Stage I - IIIB disease with
- disease technically unsuitable for radical therapy, or · weight loss in excess of 10%, or
- concurrent medical illness
- Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a FDG-PET only solitary metastasis.
- All potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.
- No prior radiotherapy or chemotherapy for non-small cell lung cancer.
- ECOG performance status 0, 1.
- Adequate hepatic, bone marrow and renal function.
- If patient is female of child bearing potential, she must not be pregnant or lactating. Males and females of reproductive potential must practise adequate contraception.
- Written informed consent.
Exclusion
- Patient unable to receive all therapy as an outpatient.
- Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
- Receiving treatment with another investigational agent.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00193921
Start Date
February 1 2003
End Date
December 1 2012
Last Update
August 4 2014
Active Locations (8)
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1
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
2
Mater Misericordiae Hospital
Brisbane, Queensland, Australia, 4101
3
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
4
North Queensland Oncology Service
Townsville, Queensland, Australia, 4810