Clinical trial · Interventional
Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia
Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protracted Course Radiotherapy | Radiation | — | UNRESOLVED |
| Short Course Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Protracted Course Radiotherapy
- description
- High Dose Rate brachytherapy 8.0 Gy x 2 External beam radiotherapy 30 Gy in 10 fractions of 3.0 Gy
- interventionNames
- Radiation: Protracted Course Radiotherapy
- type
- EXPERIMENTAL
- label
- Short Course Radiotherapy
- description
- High Dose Rate brachytherapy 8.0 Gy x 2 External beam radiotherapy 20 Gy in 5 fractions of 4.0 Gy
- interventionNames
- Radiation: Short Course Radiotherapy
Primary outcomes (1)
- measure
- Dysphagia relief
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 81 Years
Show eligibility criteria text
Inclusion Criteria: * Endoscopic and biopsy-proven carcinoma of the esophagus, either Adenocarcinoma or Squamous cell carcinoma; * Lesions of the thoracic oesophagus and the abdominal oesophagus but not involving the cardia of the stomach. (The oesophagus extends from the cricopharyngeus muscle at the level of the cricoid cartilage to the GEJ junction. The most proximate cervical oesophagus extends approximately 2-3 cm distal to the cricopharyngeus muscle approximately 18 cm from the incisors, and is excluded from this study; however the remaining oesophagus is included in this study, including the last 1-2 cm of the oesophagus which is intra-abdominal and up to the GEJ.); * Dysphagia immediately prior to the first HDR ILBT session (based on a 4-question summary score of 4-15 (i.e. less than a score of 16) using four of the questions from the EORTC QLQ OES-18 measure; * Able to insert the intra-esophageal applicator (Dilatation is allowed to open up the tumor/lumen to facilitate insertion, and this does not preclude eligibility. Any oesophageal stent must be removed prior to brachytherapy because metal stents may inappropriately increase the dose of radiation to the esophageal wall by approximately 10%.\]); * Karnofsky is between 40 and 90, inclusive and at baseline (no patient can be 100 as all will have at least dysphagia from disease at baseline; patients with KPS \<40 are not eligible for this study); * Eligible for radiotherapy (e.g. any pacemaker is not within 2.5 cm of the outside of the field edge for the EBRT component of therapy); * Signed informed consent. Exclusion Criteria: * Age less than 18; * Patients suitable for curative treatment with either surgery or chemo-radiation; * Tracheo-esophageal fistula, or deep mucosal ulceration; * Perforation or massive esophageal bleeding ; * Previous treatment (e.g. chemotherapy, radiation therapy, laser therapy or surgery) for esophageal cancer (gastrostomy or PEG does not constitute exclusion criteria, and should be considered for patients with complete obstruction or where there has been substantial loss in body weight prior to diagnosis); * Stents in situ (i.e. not removed prior to the first HDR ILBT); * Previous thoracic radiation therapy for any cause, either EBRT or ILBT; * Evidence of other uncontrolled malignancies, or evidence of synchronous head and neck or lung primary cancers (regardless of whether those malignancies could be managed with curative intent); * Failure to complete all baseline assessments required for the study, including patient-elicited scores for symptoms and QOL; * Pregnant or lactating patients.
References
Publications (4)
- BACKGROUNDSur 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. PMID 9457834
- BACKGROUNDSur 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. PMID 12007950
- BACKGROUNDGaspar 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. PMID 9212013
- BACKGROUNDKumar 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. PMID 8262829