A Randomised Phase III Study in Advanced Oesophageal Cancer to Compare Quality of Life and Palliation of Dysphagia in Patients Treated With Radiotherapy vs ChemoRadiotherapy.
18 Years
N/A
Both
Esophagus Cancer
Trial Information
A Randomised Phase III Study in Advanced Oesophageal Cancer to Compare Quality of Life and Palliation of Dysphagia in Patients Treated With Radiotherapy vs ChemoRadiotherapy.
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.
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
- Performance status ECOG ≤ 2
- Patients must begin treatment within 2 weeks of randomisation.
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relief of dysphagia
Outcome Time Frame:
This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.
Safety Issue:
No
Principal Investigator
Michael Penniment, FRANZCR
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Adelaide Hopsital
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
TROG 03.01
NCT ID:
NCT00193882
Start Date:
July 2003
Completion Date:
December 2013
Related Keywords:
- Esophagus Cancer
- Oesophageal
- Dysphagia
- Palliation
- Quality of Life
- Radiotherapy
- Chemotherapy
- Deglutition Disorders
- Esophageal Diseases
- Esophageal Neoplasms
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