Chemoradiotherapy in Patients With Localised Lung Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Collaborators: Cancer Council Queensland; Victorian Cancer Council
• Treatments: Cisplatin; Gemcitabine; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Histologically or cytologically proven non-small cell lung cancer.

• Planned high dose palliative radiation therapy for locoregional control. Examples include patients with:

1. Stage I - IIIB disease with

• disease technically unsuitable for radical therapy, or · weight loss in excess of 10%, or

• concurrent medical illness

2. 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 Criteria:

• 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.