Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
NCT ID: NCT00193882
Last Updated: 2017-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2003-07-07
2013-06-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chemoradiotherapy for Advanced Esophageal Cancer
NCT02297217
Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
NCT00002884
Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia
NCT00665197
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus
NCT00002631
Radiation Therapy and Paclitaxel, Carboplatin, and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
NCT00022139
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A: Radiotherapy
Radiotherapy alone
Radiotherapy
35 Gy in 15 fractions
B: Chemo-radiotherapy
Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
Cisplatin
80mg/m2 IV day 1
Radiotherapy
35 Gy in 15 fractions
5-Fluorouracil
800mg/m2/day IV days 1 - 4
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cisplatin
80mg/m2 IV day 1
Radiotherapy
35 Gy in 15 fractions
5-Fluorouracil
800mg/m2/day IV days 1 - 4
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Health and Medical Research Council, Australia
OTHER
Canadian Cancer Trials Group
NETWORK
Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Penniment, FRANZCR
Role: STUDY_CHAIR
Royal Adelaide Hopsital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Liverpool Hospital
Liverpool, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Premion - Wesley
Auchenflower, Queensland, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Radiation Oncology - Mater Centre
South Brisbane, Queensland, Australia
North Queensland Oncology Service
Townsville, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Launceston General Hospital
Launceston, Tasmania, 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
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Cross Cancer Centre
Edmonton, Alberta, Canada
Cancer Care Manitoba Winnipeg
Winnipeg, Manitoba, Canada
Saint John Regional Hospital - Atlantic Health Sci
Saint John, New Brunswick, 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
Princess Margaret Hospital
Toronto, Ontario, Canada
Hotel-Dieu de Quebec
Québec, , Canada
Christchurch Hospital
Christchurch, , New Zealand
Princess Royal Hospital
Hull, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information about this study on the TROG official website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCIC CTG ES.2
Identifier Type: OTHER
Identifier Source: secondary_id
TGA 2004/83
Identifier Type: OTHER
Identifier Source: secondary_id
NHMRC 291103
Identifier Type: OTHER
Identifier Source: secondary_id
TROG 03.01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.