Chemoradiotherapy in Patients With Localised Lung Cancer

Non Small Cell Lung Carcinoma Clinical Trial

Official title:

A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193921
• Other study ID #: TROG 03.07
• Secondary ID: PMCC Protocol No
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: July 31, 2014
• Start date: February 2003
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

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 radiation, only cures a fraction of such patients.

Radical radiation is not feasible for all patients with unresectable Stage IIIA or IIIB non-small cell lung cancer, based upon the extent of the loco-regional disease or the medical state of the patient. Patients of good performance status receiving protracted high-dose palliative radiotherapy do obtain a survival benefit from this therapy. Studies have shown a survival advantage by adding chemotherapy to radical radiation therapy: but studies in the high-dose palliative radiotherapy setting are lacking. Two regimens of concurrent chemotherapy with high-dose palliative radiotherapy have been developed locally, with established MTDs. These 2 regimens do warrant a comparative assessment in a phase II trial, prior to a phase III trial against high dose palliative radiation alone (36Gy/12#/5).

This is a randomised phase II trial comprising of 2 arms for randomization as follows:

Arm A:External beam radiation, 40 Gy/20#/5 per week, Plus concurrent Vinorelbine, IV, 25mg/m2, days 1, 8, 22 and + Cisplatin 20mg/m2, IV, weekly

Arm B:External beam radiation, 30 Gy/15#/5 per week, Plus concurrentGemcitabine, 200mg (flat dose) IV days 1, 8, 15

An equal number of patients will be randomised to each arm. The randomisation will be carried out by the Princess Alexandra Trial Centre.

Patients will be assessed at baseline, weekly during treatment, and then at 3 weeks, 6 weeks and 12 weeks post treatment then 3 monthly thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Carcinoma

Intervention

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
• Cisplatin
20mg/m2, IV, weekly

Radiation:
• High Dose Radiotherapy
External beam radiation, 30 Gy/15#/5 per week

Locations

Country	Name	City	State
Australia	Mater Misericordiae Hospital	Brisbane	Queensland
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Frankston Hospital	Frankston	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	North Queensland Oncology Service	Townsville	Queensland
Australia	The John Flynn Hospital	Tugun	Queensland
Australia	Border Medical Oncology	Wondonga	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	Cancer Council Queensland, Victorian Cancer Council

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (RECIST criteria)		Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.	No
Primary	Symptomatic response rate		Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.	No
Primary	The feasibility (i.e. % of patients who cannot complete the planned RT dose or who require a break for toxicity) and problems encountered with protocol compliance in the setting of a multi-institutional TROG study.		Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.	No
Primary	Toxicity of both treatments		Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.	Yes
Secondary	Progression-free survival		Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.	No
Secondary	QOL as assessed by FACT-L version 4.		Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.	No

External Links

•   Click here for more information about this study on the TROG official website