Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
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.
4 other identifiers
interventional
220
4 countries
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2003
Longer than P75 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2013
CompletedJuly 12, 2017
July 1, 2017
8.7 years
September 13, 2005
July 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Dysphagia progression free survival.
This will be measured from randomisation to the time of first progression of dysphagia.
Quality of Life differences post treatment and at 3 months and 6 months.
post treatment and at 3 months and 6 months.
Acute and late toxicity.
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Survival.
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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.
- +2 more secondary outcomes
Study Arms (2)
A: Radiotherapy
ACTIVE COMPARATORRadiotherapy alone
B: Chemo-radiotherapy
EXPERIMENTALChemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
Interventions
35 Gy in 15 fractions
800mg/m2/day IV days 1 - 4
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2069, Australia
Premion - Wesley
Auchenflower, Queensland, 4006, Australia
Royal Brisbane Hospital
Herston, Queensland, 4029, Australia
Radiation Oncology - Mater Centre
South Brisbane, Queensland, 4101, Australia
North Queensland Oncology Service
Townsville, Queensland, 4810, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Peter MacCallum - Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Peter MacCallum - Moorrabbin
East Bentleigh, Victoria, 3165, Australia
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 8006, Australia
Royal Perth Hospital
Perth, Western Australia, 6001, Australia
Cross Cancer Centre
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Care Manitoba Winnipeg
Winnipeg, Manitoba, R3E 0V9, Canada
Saint John Regional Hospital - Atlantic Health Sci
Saint John, New Brunswick, E2L 4L2, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Cancer Centre of Southeastern Ontario Kingston
Kingston, Ontario, K7L 5P9, Canada
Grand River Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Hotel-Dieu de Quebec
Québec, G1R 2J6, Canada
Christchurch Hospital
Christchurch, 4710, New Zealand
Princess Royal Hospital
Hull, United Kingdom
Related Publications (1)
Penniment MG, De Ieso PB, Harvey JA, Stephens S, Au HJ, O'Callaghan CJ, Kneebone A, Ngan SY, Ward IG, Roy R, Smith JG, Nijjar T, Biagi JJ, Mulroy LA, Wong R; TROG 03.01/CCTG ES.2 group. Palliative chemoradiotherapy versus radiotherapy alone for dysphagia in advanced oesophageal cancer: a multicentre randomised controlled trial (TROG 03.01). Lancet Gastroenterol Hepatol. 2018 Feb;3(2):114-124. doi: 10.1016/S2468-1253(17)30363-1. Epub 2017 Dec 14.
PMID: 29248399DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Penniment, FRANZCR
Royal Adelaide Hopsital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
July 7, 2003
Primary Completion
March 21, 2012
Study Completion
June 18, 2013
Last Updated
July 12, 2017
Record last verified: 2017-07