Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia.
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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: Radiation therapy 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. |
- 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 ]
- 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 ]
| Estimated Enrollment: | 220 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Radiotherapy alone
|
Radiation: Radiation therapy
35 Gy in 15 fractions
Other Name: Radiation
|
|
Experimental: B
Chemo-radiotherapy
|
Drug: Cisplatin
80mg/m2 IV day 1
Other Name: Cisplatin Injection
Radiation: Radiation therapy
35 Gy in 15 fractions
Other Name: Radiation
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:
Radiotherapy Alone
- 35 Gy in 15 fractions (Australia and New Zealand) or
- 30 Gy in 10 fractions(Canada ONLY)
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 |
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
- Performance status ECOG ≤ 2
- Patients must begin treatment within 2 weeks of randomisation.
- 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.
Contacts and Locations| Contact: Michael Penniment, FRANZCR | +61 (0) 8 8222 4800 | mpennime@mail.rah.sa.gov.au |
Show 25 Study Locations| Study Chair: | Michael Penniment, FRANZCR | Royal Adelaide Hopsital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Michael Penniment, 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: | September 30, 2009 |
| 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 Diseases Esophageal Neoplasms 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 May 19, 2013