Chemoradiotherapy in Patients With Localised Lung Cancer - Full Text View

Purpose

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:

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

Condition	Intervention	Phase
Non Small Cell Lung Carcinoma	Drug: Vinorelbine Radiation: High dose Radiotherapy Drug: Gemcitabine Drug: Cisplatin Radiation: High Dose Radiotherapy	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Vinorelbine Gemcitabine Gemcitabine hydrochloride Vinorelbine tartrate

U.S. FDA Resources

Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:

Objective response rate (RECIST criteria) [ Time Frame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial. ] [ Designated as safety issue: No ]
Symptomatic response rate [ Time Frame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial. ] [ Designated as safety issue: No ]
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. [ Time Frame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial. ] [ Designated as safety issue: No ]
Toxicity of both treatments [ Time Frame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression-free survival [ Time Frame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial. ] [ Designated as safety issue: No ]
QOL as assessed by FACT-L version 4. [ Time Frame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial. ] [ Designated as safety issue: No ]

Enrollment:	82
Study Start Date:	February 2003
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Vinorelbine + cisplatin + high-dose palliative radiotherapy	Drug: Vinorelbine IV, 25mg/m2, days 1, 8, 22 Other Name: Navelbine, Vinorelbine Ebewe Radiation: High dose Radiotherapy External beam radiation, 40 Gy/20#/5 per week Other Name: Radiation Drug: Cisplatin 20mg/m2, IV, weekly Other Name: Cisplatin Ebewe, Cisplatin Injection
Active Comparator: B Gemcitabine + high-dose palliative radiotherapy	Drug: Gemcitabine 200mg (flat dose) IV days 1, 8, 15 Other Name: Gemzar, Xeloda Radiation: High Dose Radiotherapy External beam radiation, 30 Gy/15#/5 per week Other Name: Radiation

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193921

Locations

Australia, New South Wales
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Mater Misericordiae Hospital
Brisbane, Queensland, Australia, 4101
North Queensland Oncology Service
Townsville, Queensland, Australia, 4810
The John Flynn Hospital
Tugun, Queensland, Australia, 4224
Australia, Victoria
Frankston Hospital
Frankston, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006
Border Medical Oncology
Wondonga, Victoria, Australia

Sponsors and Collaborators

Trans-Tasman Radiation Oncology Group (TROG)

Queensland Cancer Fund

Victorian Cancer Council

Investigators

Study Chair:	Michael Michael	Peter MacCallum Cancer Centre, Australia
Study Chair:	Bryan Burmeister	Princess Alexandra Hospital

More Information

Additional Information:

Click here for more information about this study on the TROG official website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Associate Professor Bryan Burmeister, Trans Tasman Radiation Oncology Group
ClinicalTrials.gov Identifier:	NCT00193921 History of Changes
Other Study ID Numbers:	TROG 03.07, PMCC Protocol No. 03/85
Study First Received:	September 13, 2005
Last Updated:	September 29, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):

Chemoradiotherapy
High dose
palliative radiotherapy
Quality of life

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Vinorelbine

Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013