Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193882
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2005-09-13
Brief Title:
Advanced Oesophageal Cancer Study to Compare Quality of Life and Palliation of Dysphagia
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients 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 fractionsCanada ONLY
2 Chemo-Radiotherapy
35 Gy in 15 fractions Australia and New Zealand or
30 Gy in 10 fractions Canada ONLY
Cisplatin 80mgm2 IV day 1 or 20mgm2day IV days 1 - 4
5-Fluorouracil 800mgm2day 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
Dysphagia is the commonest presenting symptom due to local disease obstructing the oesophagus Difficulty eating not only affects the patients 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 fractionsCanada ONLY
2 Chemo-Radiotherapy
35 Gy in 15 fractions Australia and New Zealand or
30 Gy in 10 fractions Canada ONLY
Cisplatin 80mgm2 IV day 1 or 20mgm2day IV days 1 - 4
5-Fluorouracil 800mgm2day 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHMRC 291103 | OTHER | National Health and Medical Research Council | None |
| NCIC CTG ES2 | OTHER | None | None |
| TGA 200483 | OTHER | None | None |