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

July 10, 2017 updated by: Trans Tasman Radiation Oncology Group

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.

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Liverpool, New South Wales, Australia, 1871
        • Liverpool Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australia, 2069
        • Royal North Shore Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4006
        • Premion - Wesley
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Radiation Oncology - Mater Centre
      • Townsville, Queensland, Australia, 4810
        • North Queensland Oncology Service
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Peter MacCallum - Box Hill Hospital
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Care Centre, Geelong Hospital
      • Melbourne, Victoria, Australia, 8006
        • Peter MacCallum Cancer Centre
      • east Bentleigh, Victoria, Australia, 3165
        • Peter MacCallum - Moorrabbin
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Royal Perth Hospital
      • Quebec, Canada, G1R 2J6
        • Hotel-Dieu de Quebec
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba Winnipeg
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital - Atlantic Health Sci
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario Kingston
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Christchurch, New Zealand, 4710
        • Christchurch Hospital
      • Hull, United Kingdom
        • Princess Royal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: Radiotherapy
Radiotherapy alone
35 Gy in 15 fractions
Other Names:
  • Radiation
  • Radiation Therapy
Experimental: B: Chemo-radiotherapy
Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
35 Gy in 15 fractions
Other Names:
  • Radiation
  • Radiation Therapy
80mg/m2 IV day 1
Other Names:
  • Cisplatin Injection
800mg/m2/day IV days 1 - 4
Other Names:
  • DBL Flurouracil Injection BP, Efudix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relief of dysphagia
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.
This will be measured at nine weeks after the start of radiotherapy and must be maintained at the next review 4 weeks thereafter.

Secondary Outcome Measures

Outcome Measure
Time Frame
Dysphagia progression free survival.
Time Frame: This will be measured from randomisation to the time of first progression of dysphagia.
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.
Time Frame: post treatment and at 3 months and 6 months.
post treatment and at 3 months and 6 months.
Acute and late toxicity.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Survival.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
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.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Number of patients receiving secondary treatment (radiation, chemotherapy or stenting).
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Time to achieving a complete response i.e. dysphagia score of 0.
Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.
Interim analyses planned at 110 pateints. Final analyses will occur after 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Michael Penniment, FRANZCR, Royal Adelaide Hopsital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 7, 2003

Primary Completion (Actual)

March 21, 2012

Study Completion (Actual)

June 18, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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