| CTRI Number |
CTRI/2024/11/077406 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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) |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar Choubey |
| Designation |
Assistant Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi, Uttar Pradesh, India 221005
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8887596428 |
| Fax |
|
| Email |
ajaykc@mpmmcc.tmc.gov.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajay Kumar Choubey |
| Designation |
Assistant Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi, Uttar Pradesh, India 221005
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8887596428 |
| Fax |
|
| Email |
ajaykc@mpmmcc.tmc.gov.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajay Kumar Choubey |
| Designation |
Assistant Professor |
| Affiliation |
Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi, Uttar Pradesh, India 221005
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8887596428 |
| Fax |
|
| Email |
ajaykc@mpmmcc.tmc.gov.in |
|
|
Source of Monetary or Material Support
|
| MAHAMANA PANDIT MADAN MOHAN MALVIYA CANCER CENTRE,SUNDERBAGIYA NEAR NARIA GATE BHU CAMPUS VARANASI UTTAR PRADESH 221005 |
|
|
Primary Sponsor
|
| Name |
TMH TRAC |
| Address |
Tata Memorial Hospital Dr. E Borges Road, Parel, Mumbai - 400 012 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Kumar Choubey |
Mahamana Pandit Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer Hospital |
Department of Radiation Oncology, Mahamana Pandit
Madan Mohan Malviya Cancer Centre and Homi Bhabha Cancer
Hospital Varanasi, Uttar
Pradesh, India Varanasi UTTAR PRADESH |
8887596428
ajaykc@mpmmcc.tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 to a dose of 12 Gy in 2 sessions of 6 Gy each. |
| Comparator Agent |
External beam radiation arm |
External Beam Radiation to a dose of 30 Gy in 10 fractions over 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of dysphagia would be evaluated with physician assessed 5 points Ogilvie’s score. (primary outcome) |
Ogilvie’s score-pretreatment, post-treatment, 1 month, 3 month and 6 months post treatment. (primary outcome)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 incurred |
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. |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Esophageal cancers often present late in their natural course of disease. In the advanced stages, many of the patients would not be suitable for treatment with a curative approach. Therefore, effective palliative treatment is necessary to decrease the burden of symptoms and improve quality of life. The ideal palliative regimen should have high rates of response with minimal toxicities. Also, patients should not be subjected to unnecessarily prolonged hospital visits. In a developing country like India, delivering effective palliative treatment with minimum hospital visits and out-of-pocket patient expenditure is crucial. One of the standard palliative external beam radiation regimens is 10 days of external beam radiotherapy (30 Grays in daily fractions over 2 weeks). However, this regimen requires at least 10 hospital visits. We wish to see if a 4 hospital visits radiation regimen combining shorter external beam radiotherapy (12 Grays in 4 fractions over 2 days, treated twice daily) with 2 sessions of intraluminal brachytherapy (12 Grays in 2 fractions) can produce potentially more relief of swallowing difficulty in esophageal patients. Decreasing treatment time would be beneficial for both the healthcare system and patients. This trial would compare the effectiveness, side effect profile, and improvement in quality of life of patients enrolled in both arms. |