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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00193882
Other study ID # TROG 03.01
Secondary ID NCIC CTG ES.2TGA
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated July 10, 2017
Start date July 7, 2003
Est. completion date June 18, 2013

Study information

Verified date July 2017
Source Trans-Tasman Radiation Oncology Group (TROG)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the treatment of gullet cancer with radiotherapy alone and assess the advantage and toxicity of adding chemotherapy. The hypothesis to be tested is as follows: That the addition of chemotherapy to a short course of radiation treatment improves the proportion of patients who achieve relief of dysphagia and improves quality of life compared to radiation alone in patients with advanced oesophageal cancer.


Description:

Prospective radical treatment trials in oesophageal cancer have shown responses in both radiotherapy alone and radiotherapy when combined with chemotherapy. Retrospective studies show a response in the palliative setting to relieve dysphagia. The response, durability and quality of life end points have not been previously fully documented. This will be addressed by this trial.

Dysphagia is the commonest presenting symptom due to local disease obstructing the oesophagus. Difficulty eating not only affects the patient's ability to maintain nutrition, but also impacts on all areas of quality of life. Relief of dysphagia becomes the highest priority for treatment.

At the time of developing this protocol there were no randomised trials comparing chemo-radiotherapy and radiotherapy in the palliative setting.

Few studies have prospectively assessed quality of life data for patients with oesophageal cancer, and although toxicity and survival data is available, there is no long-term data on quality of life. This trial will assess quality of life in a consecutive manner using a standardised self-reporting measure of quality of life, and compare quality of life across two groups having different treatments.

Eligible patients are those with proven carcinoma of the oesophagus who are deemed not suitable for definitive radical treatment due to the advanced nature of disease, presence of metastases or intercurrent illness, who have symptomatic dysphagia requiring loco-regional palliation.

Patients will be randomised to the following treatment options:

1. Radiotherapy Alone

- 35 Gy in 15 fractions (Australia and New Zealand) or

- 30 Gy in 10 fractions(Canada ONLY)

2. Chemo-Radiotherapy

- 35 Gy in 15 fractions (Australia and New Zealand) or

- 30 Gy in 10 fractions (Canada ONLY)

- Cisplatin 80mg/m2 IV day 1 (or 20mg/m2/day IV days 1 - 4)

- 5-Fluorouracil 800mg/m2/day IV days 1 - 4

Patients will have an initial baseline assessment then be followed up weekly during treatment, monthly for 1 year post treatment and then 3 monthly.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date June 18, 2013
Est. primary completion date March 21, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Biopsy proven Carcinoma of the oesophagus.

- Not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. (It should be noted that, patients with mediastinal nodes and no more distant disease maybe suitable for radical treatment).

- Symptomatic patients with dysphagia scores of = 1 i.e. able to eat only some solids (see Mellow Scale appendix 1)

- Performance status ECOG = 2

- Patients must begin treatment within 2 weeks of randomization.

- Patient is at least 18 years old.

- Adequate haematological function to undergo chemotherapy. Peripheral blood - Neutrophils > 1.5 x 10^9/L - Platelets > 100 x 10^9/L

- Adequate renal function, Creatinine - Calculated clearance = 50 ml/min

- Patients capable of childbearing are using adequate contraception.

- Written informed consent of patient.

Exclusion Criteria:

- Previous mega-voltage external beam Radiotherapy or brachy-therapy delivered to the region of the chest.

- Synchronous active malignancies.

- Pregnant or lactating patients.

- Patients unfit for any treatment component.

- Tracheo-oesophageal fistula.

- Stents in situ.

- Previous chemotherapy for Oesophageal Cancer

- CT scan of thorax and abdomen more than 8 weeks prior to randomization

- Full Blood Count, Biochemistry (including creatinine) and creatinine clearance more than 2 weeks prior to randomization

Study Design


Intervention

Drug:
Cisplatin
80mg/m2 IV day 1
Radiation:
Radiotherapy
35 Gy in 15 fractions
Drug:
5-Fluorouracil
800mg/m2/day IV days 1 - 4

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Premion - Wesley Auchenflower Queensland
Australia Peter MacCallum - Box Hill Hospital Box Hill Victoria
Australia Peter MacCallum - Moorrabbin east Bentleigh Victoria
Australia Andrew Love Cancer Care Centre, Geelong Hospital Geelong Victoria
Australia Royal Brisbane Hospital Herston Queensland
Australia Launceston General Hospital Launceston Tasmania
Australia Liverpool Hospital Liverpool New South Wales
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Royal Perth Hospital Perth Western Australia
Australia Prince of Wales Hospital Randwick New South Wales
Australia Radiation Oncology - Mater Centre South Brisbane Queensland
Australia Royal North Shore Hospital Sydney New South Wales
Australia North Queensland Oncology Service Townsville Queensland
Australia Princess Alexandra Hospital Woolloongabba Queensland
Canada Cross Cancer Centre Edmonton Alberta
Canada Nova Scotia Cancer Centre Halifax Nova Scotia
Canada Cancer Centre of Southeastern Ontario Kingston Kingston Ontario
Canada Grand River Cancer Centre Kitchener Ontario
Canada Hotel-Dieu de Quebec Quebec
Canada Saint John Regional Hospital - Atlantic Health Sci Saint John New Brunswick
Canada Princess Margaret Hospital Toronto Ontario
Canada Cancer Care Manitoba Winnipeg Winnipeg Manitoba
New Zealand Christchurch Hospital Christchurch
United Kingdom Princess Royal Hospital Hull

Sponsors (3)

Lead Sponsor Collaborator
Trans-Tasman Radiation Oncology Group (TROG) Canadian Cancer Trials Group, National Health and Medical Research Council, Australia

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relief of dysphagia This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
Secondary Dysphagia progression free survival. This will be measured from randomisation to the time of first progression of dysphagia.
Secondary Quality of Life differences post treatment and at 3 months and 6 months. post treatment and at 3 months and 6 months.
Secondary Acute and late toxicity. Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary Survival. Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary Time to achieving any response in dysphagia after treatment as measured by an improvement of at least 1 point on the 5 point dysphagia scale. Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary Number of patients receiving secondary treatment (radiation, chemotherapy or stenting). Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Secondary Time to achieving a complete response i.e. dysphagia score of 0. Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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