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Hypothesis: In the management of advanced oesophageal cancer, to determine if a shorter regime of external beam radiotherapy (using higher daily doses, and combined with intraluminal high dose rate brachytherapy) is not inferior in the palliation of dysphagia than a more protracted course of external beam radiotherapy (using lower daily doses and combined with equal intraluminal high dose rate brachytherapy).
This is a prospective, pragmatic and multi-centre clinical trial, without blinding or masking to the randomly assigned treatment. Patient registration and randomization are centralized. There are two arms to the study, expecting an equal numbers of patients randomized to each arm. Stratification will by according to: (1) treating institution/country, and (2) baseline Stage (M1 = distant metastases versus M0 = no distant metastases). The primary statistical analysis will be conducted as an "intention-to-treat" clinical trial.
A cost-effectiveness analysis is not required because the main contrast is between 5 and 10 fractions of EBRT, where 5 fractions are less expensive than 10 fractions. This protocol follows the recommendations of CONSORT for the reporting of non-inferiority and equivalence trials. The active control is 30 Gy in 10 fractions, and the new therapy is 20 Gy in 5 fractions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protracted Course Radiotherapy | Active Comparator | High Dose Rate brachytherapy 8.0 Gy x 2 External beam radiotherapy 30 Gy in 10 fractions of 3.0 Gy |
|
| Short Course Radiotherapy | Experimental | High Dose Rate brachytherapy 8.0 Gy x 2 External beam radiotherapy 20 Gy in 5 fractions of 4.0 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protracted Course Radiotherapy | Radiation | External Beam Radiation 30 Gy in 10 fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia relief | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 3 years | |
| Treatment Toxicity | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Rosenblatt, MD | International Atomic Energy Agency | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Credit Valley Hospital Statistical Centre | Credit Valley | Ontario | L5M 2N1 | Canada | ||
| Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9457834 | Background | Sur RK, Donde B, Levin VC, Mannell A. Fractionated high dose rate intraluminal brachytherapy in palliation of advanced esophageal cancer. Int J Radiat Oncol Biol Phys. 1998 Jan 15;40(2):447-53. doi: 10.1016/s0360-3016(97)00710-4. | |
| 12007950 | Background | Sur RK, Levin CV, Donde B, Sharma V, Miszczyk L, Nag S. Prospective randomized trial of HDR brachytherapy as a sole modality in palliation of advanced esophageal carcinoma--an International Atomic Energy Agency study. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):127-33. doi: 10.1016/s0360-3016(02)02702-5. |
| Label | URL |
|---|---|
| IAEA website | View source |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Short Course Radiotherapy | Radiation | External Beam Radiation 20 Gy in 5 fractions |
|
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| University of Zagreb Clinical Hospital | Zagreb | City of Zagreb | 10000 | Croatia |
| Tata Memorial Hospital | Mumbai | Parel | 490 012 | India |
| Institute of Nuclear Medicine and Oncology | Lahore | Punjab Province | 54600 | Pakistan |
| University of the Witwatersrand Department of Radiat. Oncology | Johannesburg | Parktown | 2193 | South Africa |
| Mahidol University Faculty of Medicine Siriraj Hospital | Bangkok | Siriraj | 10700 | Thailand |
| 9212013 | Background | Gaspar LE, Nag S, Herskovic A, Mantravadi R, Speiser B. American Brachytherapy Society (ABS) consensus guidelines for brachytherapy of esophageal cancer. Clinical Research Committee, American Brachytherapy Society, Philadelphia, PA. Int J Radiat Oncol Biol Phys. 1997 Apr 1;38(1):127-32. doi: 10.1016/s0360-3016(97)00231-9. |
| 8262829 | Background | Kumar MU, Swamy K, Supe SS, Anantha N. Influence of intraluminal brachytherapy dose on complications in the treatment of esophageal cancer. Int J Radiat Oncol Biol Phys. 1993 Dec 1;27(5):1069-72. doi: 10.1016/0360-3016(93)90525-z. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |