NCT00193921

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. 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. 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. 3.Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine + high-dose palliative radiotherapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

6.8 years

First QC Date

September 13, 2005

Last Update Submit

July 31, 2014

Conditions

Non Small Cell Lung Carcinoma

Keywords

ChemoradiotherapyHigh dosepalliative radiotherapyQuality of life

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Secondary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

A

EXPERIMENTAL

Vinorelbine + cisplatin + high-dose palliative radiotherapy

Drug: VinorelbineRadiation: High dose RadiotherapyDrug: Cisplatin

B

ACTIVE COMPARATOR

Gemcitabine + high-dose palliative radiotherapy

Drug: GemcitabineRadiation: High Dose Radiotherapy

Interventions

VinorelbineDRUG

IV, 25mg/m2, days 1, 8, 22

Also known as: Navelbine, Vinorelbine Ebewe
A
High Dose RadiotherapyRADIATION

External beam radiation, 40 Gy/20#/5 per week

Also known as: Radiation
A
GemcitabineDRUG

200mg (flat dose) IV days 1, 8, 15

Also known as: Gemzar, Xeloda
B
CisplatinDRUG

20mg/m2, IV, weekly

Also known as: Cisplatin Ebewe, Cisplatin Injection
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

Mater Misericordiae Hospital

Brisbane, Queensland, 4101, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

North Queensland Oncology Service

Townsville, Queensland, 4810, Australia

Location

The John Flynn Hospital

Tugun, Queensland, 4224, Australia

Location

Frankston Hospital

Frankston, Victoria, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

Border Medical Oncology

Wondonga, Victoria, Australia

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

VinorelbineRadiotherapyRadiationGemcitabineCapecitabineCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTherapeuticsPhysical PhenomenaDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Michael Michael

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

  • Bryan Burmeister

    Princess Alexandra Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

February 1, 2003

Primary Completion

December 1, 2009

Study Completion

December 1, 2012

Last Updated

August 4, 2014

Record last verified: 2014-07

Locations

AU(8)