Esophageal Brachytherapy (ILRT) with Short course Hypofractionated accelerated EBRT versus EBRT alone in palliative treatment of esophageal cancers: a randomized phase III trial. (EBRISH trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077406

Enrollment

Registered

2024-11-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified

Interventions

Intervention1: External Beam Radiation + Brachytherapy arm: Hypo fractionated external beam radiation to a dose of 12 Gy in 4 fractions over 2 days (twice daily) followed by Intraluminal brachytherapy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 years 2. Metastatic esophageal cancer patients or patients not suitable for radical treatment (after MDT discussion) 3. Squamous cell carcinoma or adenocarcinoma of the esophagus 4. ECOG PS 0 to 3 5. Willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. Upper extent of disease within 2 cm from upper esophageal sphincter 2. Lower extent of disease within 1 cm from gastroesophageal junction 3. ECOG PS 4 4. Deep ulceration 5. Trachea-esophageal fistula 6. Previous radiation therapy or surgery in the thoracic region. 7. Stents in situ before radiotherapy

Design outcomes

Primary

Measure	Time frame
Degree of dysphagia would be evaluated with physician assessed 5 points Ogilvie’s score. (primary outcome)Timepoint: Ogilvie’s score-pretreatment, post-treatment, 1 month, 3 month and 6 months post treatment. (primary outcome)	—

Secondary

Measure	Time frame
2. Swallowing associated quality of life specific to the complaint of dysphagia would be evaluated with the EORTC QLC Oesophagus module 3. Treatment-associated toxicity would be associated with RTOG, CTCAE version 5 and patient-reported PRO-CTCAE. 4. Dysphagia-free survival would be calculated in responders with Kaplan Maier statistics 5. Overall survival would be calculated with Kaplan Maier statistics 6. Health-related quality of life would be evaluated with the EORTC QLC C15 PAL questionnaire. 7. Cost of treatment - collection of data like travel cost, accommodation cost, cost of procedure, total cost of treatment incurredTimepoint: 2. EORTC Oesophagus module – pretreatment, post-treatment – 1 month, 3 months and 6 month 3. RTOG, CTCAE v5, and PRO-CTCAE toxicity score– post-treatment 1 month and 3 month 4. Dysphagia-free survival – from last day of RT to worsening of dysphagia score. 5. Overall survival – from the date of signing of informed consent to death 6. EORTC QLC C15 PAL – pretreatment, post-treatment 1 month, 3 months and 6 months 7. Cost of treatment – on the date of radiotherapy completion.	—

Measure

Time frame

2. Swallowing associated quality of life specific to the complaint of dysphagia would be evaluated with the EORTC QLC Oesophagus module 3. Treatment-associated toxicity would be associated with RTOG, CTCAE version 5 and patient-reported PRO-CTCAE. 4. Dysphagia-free survival would be calculated in responders with Kaplan Maier statistics 5. Overall survival would be calculated with Kaplan Maier statistics 6. Health-related quality of life would be evaluated with the EORTC QLC C15 PAL questionnaire. 7. Cost of treatment - collection of data like travel cost, accommodation cost, cost of procedure, total cost of treatment incurredTimepoint: 2. EORTC Oesophagus module – pretreatment, post-treatment – 1 month, 3 months and 6 month 3. RTOG, CTCAE v5, and PRO-CTCAE toxicity score– post-treatment 1 month and 3 month 4. Dysphagia-free survival – from last day of RT to worsening of dysphagia score. 5. Overall survival – from the date of signing of informed consent to death 6. EORTC QLC C15 PAL – pretreatment, post-treatment 1 month, 3 months and 6 months 7. Cost of treatment – on the date of radiotherapy completion.

—

Countries

India

Contacts

Public ContactDr Ajay Kumar Choubey

Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi

ajaykc@mpmmcc.tmc.gov.in8887596428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026