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

Phase 2
18 Years
Open (Enrolling)
Non Small Cell Lung Carcinoma

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Trial Information

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

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.

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 ยท 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Objective response rate (RECIST criteria)

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Michael Michael

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TROG 03.07



Start Date:

February 2003

Completion Date:

December 2011

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Chemoradiotherapy
  • High dose
  • palliative radiotherapy
  • Quality of life
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms