Chemoradiotherapy in patients with localised lung cancer

Phase 2

Completed

• Conditions: ocally advanced and metastatic non-small cell lung cancer.; Locally advanced and metastatic non-small cell lung cancer.; Cancer - Lung - Non small cell

• Registration Number: ACTRN12606000519550
• Lead Sponsor: Bryan Burmeister

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Histologically or cytologically proven non-small cell lung cancer.- Planned high dose palliative radiation therapy for locoregional control. Examples include patients with: a) Stage I – IIIB disease with: -disease technically unsuitable for radical therapy, or -weight loss in excess of 10%, or -concurrent medical illness b)Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a Flurodeoxyglucose-Positron Emission Tomography (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. - European Cooperative Ooncology Group 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Objective response rate (RECIST criteria).[Response will be assessed at 6 weeks post the completion of chemoradiotherapy. ];2. Symptomatic response rate.[Will be assessed at baseline, at 3 and 6 weeks post chemoradiotherpay and at follow up every 3 months until death. ];3. The feasibility and problems encountered with protocol compliance.[When study is complete Expected duration is 2 years. ];4. Toxicity of both treatments.[Weekly during chemoradiotherapy, weekly for the first 3 weeks after and at the 6 week mark post chemoradiotherapy and then every 3 months until death.]

Secondary Outcome Measures

Name	Time	Method
1. Progression free survival.[Time interval from date of randomisation to objective documentation of tumour progression or death due to tumour progression. ];2. Quality of Life.[Baseline, at 3 and 6 weeks post chemoradiotherpay and at follow up every 3 months until death.]