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

This study has been completed.
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00193882
First received: September 13, 2005
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Esophagus Cancer
Drug: Cisplatin
Radiation: Radiotherapy
Drug: 5-Fluorouracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dysphagia progression free survival. [ Time Frame: This will be measured from randomisation to the time of first progression of dysphagia. ] [ Designated as safety issue: No ]
  • Quality of Life differences post treatment and at 3 months and 6 months. [ Time Frame: post treatment and at 3 months and 6 months. ] [ Designated as safety issue: No ]
  • Acute and late toxicity. [ Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years. ] [ Designated as safety issue: Yes ]
  • Survival. [ Time Frame: Interim analyses planned at 110 pateints. Final analyses will occur after 5 years. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 220
Study Start Date: July 2003
Study Completion Date: March 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: Radiotherapy
Radiotherapy alone
Radiation: Radiotherapy
35 Gy in 15 fractions
Other Names:
  • Radiation
  • Radiation Therapy
Experimental: B: Chemo-radiotherapy
Chemotherapy (Cisplatin + 5-Fluorouracil ) and Radiotherapy
Drug: Cisplatin
80mg/m2 IV day 1
Other Name: Cisplatin Injection
Radiation: Radiotherapy
35 Gy in 15 fractions
Other Names:
  • Radiation
  • Radiation Therapy
Drug: 5-Fluorouracil
800mg/m2/day IV days 1 - 4
Other Name: DBL Flurouracil Injection BP, Efudix

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193882

  Show 25 Study Locations
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
National Health and Medical Research Council, Australia
NCIC Clinical Trials Group
Investigators
Study Chair: Michael Penniment, FRANZCR Royal Adelaide Hopsital
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00193882     History of Changes
Other Study ID Numbers: TROG 03.01, NCIC CTG ES.2, TGA 2004/83, NHMRC 291103
Study First Received: September 13, 2005
Last Updated: July 11, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Oesophageal
Dysphagia
Palliation
Quality of Life
Radiotherapy
Chemotherapy

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014