Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.

Esophagus Cancer Clinical Trial

Official title:

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.

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
• 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

Related Conditions & MeSH terms

• Deglutition Disorders
• Esophageal Neoplasms
• Esophagus Cancer

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.

External Links

•   Click here for more information about this study on the TROG official website