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Non Small Cell Lung CarcinomaPhase 2NCT00193921

Chemoradiotherapy in Patients With Localised Lung Cancer

A Phase 2 study testing Vinorelbine, High dose Radiotherapy and Gemcitabine in people with Non Small Cell Lung Carcinoma, run by Trans Tasman Radiation Oncology Group at 8 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Carcinoma
What is being tested?
Vinorelbine, High dose Radiotherapy and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
8 sitesAustralia
Study dates
Feb 2003to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Australia8 sites

  • Mater Misericordiae Hospital

    Brisbane, Queensland, 4101

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Frankston Hospital

    Frankston, Victoria

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 8006

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298

  • North Queensland Oncology Service

    Townsville, Queensland, 4810

  • The John Flynn Hospital

    Tugun, Queensland, 4224

  • Border Medical Oncology

    Wondonga, Victoria

Other trials in Australia

About this study

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

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
Read the 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.

Being tested
Vinorelbine, High dose Radiotherapy, Gemcitabine, Cisplatin
Keywords
Chemoradiotherapy, High dose, palliative radiotherapy, Quality of life
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinorelbineDrug

    Also called Navelbine, Vinorelbine Ebewe

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

  • High dose RadiotherapyRadiation

    Also called Radiation

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

  • GemcitabineDrug

    Also called Gemzar, Xeloda

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

  • CisplatinDrug

    Also called Cisplatin Ebewe, Cisplatin Injection

    20mg/m2, IV, weekly

  • High Dose RadiotherapyRadiation

    Also called Radiation

    External beam radiation, 30 Gy/15#/5 per week

Study groups in NCT00193921
Study groupRoleWhat they receive
AExperimentalVinorelbine + cisplatin + high-dose palliative radiotherapy
Receives: Drug: Vinorelbine; Radiation: High dose Radiotherapy; Drug: Cisplatin
BActive comparatorGemcitabine + high-dose palliative radiotherapy
Receives: Drug: Gemcitabine; Radiation: High Dose Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (RECIST criteria)

    Measured: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.

  2. Symptomatic response rate

    Measured: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.

  3. 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.

    Measured: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.

  4. Toxicity of both treatments

    Measured: 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)

  1. Progression-free survival

    Measured: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.

  2. QOL as assessed by FACT-L version 4.

    Measured: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionDec 2009
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00193921
Sponsor's protocol ID
TROG 03.07
Other IDs
PMCC Protocol No. 03/85
Status last verified
Jul 2014
First submitted
13 Sep 2005
Last updated
4 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine, High dose Radiotherapy and Gemcitabine in people with Non Small Cell Lung Carcinoma, run by Trans Tasman Radiation Oncology Group at 8 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00193921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.

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