Clinical trial NCT00193921: Chemoradiotherapy in Patients With Localised Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Carcinoma
Keywords: Chemoradiotherapy
High dose
palliative radiotherapy
Quality of life
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: Cancer Council Queensland
name: Victorian Cancer Council
First posted: 2005-09-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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

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 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.

Primary outcomes:
measure: Objective response rate (RECIST criteria)
timeFrame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
measure: Symptomatic response rate
timeFrame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
measure: 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.
timeFrame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
measure: Toxicity of both treatments
timeFrame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Secondary outcomes:
measure: Progression-free survival
timeFrame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
measure: QOL as assessed by FACT-L version 4.
timeFrame: Final analysis will occur when all have a minimum 1 year follow-up after randomisation. Approx 3 years after start of trial.
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Misericordiae Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Townsville
country: Australia
facility: North Queensland Oncology Service
state: Queensland
city: Tugun
country: Australia
facility: The John Flynn Hospital
state: Queensland
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Wondonga
country: Australia
facility: Border Medical Oncology
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Michael Michael
role: STUDY_CHAIR
affiliation: Princess Alexandra Hospital
name: Bryan Burmeister
role: STUDY_CHAIR
References: