| CTRI Number |
CTRI/2023/05/052661 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Other |
|
Public Title of Study
|
Dysphagia releif in advanced esophageal cancer through Radiotherapy |
|
Scientific Title of Study
|
A Comparative Analysis of Dysphagia Relief with External Beam Radiotherapy versus Brachytherapy with External Beam Conditioning in Advanced Esophageal Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Mukherji |
| Designation |
Head Of The Department |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Naria, Varanasi
Same as address
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9489146747 |
| Fax |
|
| Email |
drashutoshm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashutosh Mukherjee |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Radiation Oncology, Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Naria, Varanasi
Same as address
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9489146747 |
| Fax |
|
| Email |
drashutoshm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya jain |
| Designation |
Jr. Resident |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sunder Bagiya Near Nariya Gate, Varanasi
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sunder Bagiya Near Nariya Gate, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8249571257 |
| Fax |
|
| Email |
jshreyaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Naria, Varanasi, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Shreya Jain |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital |
Department of Radiation Oncology
Varanasi
UTTAR PRADESH |
8249571257
jshreyaya@gmail.com |
|
|
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 |
| Comparator Agent |
EBRT |
External Beam Radiotherapy will be given (30Gy in 10#) over 2 weeks for each patient; total duration of Study 18 months from June 2023 |
| Intervention |
EBRT followed by ILBT |
External beam radiotherapy will be given (same as in comparator arm) followed by intraluminal brachytherapy (6 Gy weekly over 2 weeks); Duration total 3.5 weeks for each patient; total duration of study will be 18 months from June 2023. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Endoscopic and biopsy-proven carcinoma of the esophagus either adenocarcinoma or squamous cell carcinoma
Patient not suitable for radical treatment either
Due to poor KPS
Extent of local disease (Primary Stage T4b)
Unsuitable for concurrent chemotherapy
Metastatic disease at presentation
Lesions of the thoracic esophagus and the abdominal esophagus that do not involve the cardiac of the stomach
Recent imaging (a computed tomography (CT) of the chest and abdomen or whole body PETCT) not more than 3 months old
Maximum tumor length not more than 10 cm
Dysphagia immediately before radiation
Karnofskys performance score is between 40 and 90 inclusive and at baseline
Signed informed consent
|
|
| ExclusionCriteria |
| Details |
Age less than 18
Expected intraluminal catheter insertion not possible even after conditioning radiotherapy
Tracheoesophageal fistula or deep mucosal ulceration
Perforation or massive esophageal bleeding
Stents in situ (i.e. not removed before 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)
Pregnant or lactating patients
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare dysphagia relief (change in grade of dysphagia) in radiation naïve esophageal cancer patients with high-grade dysphagia treated with external beam radiotherapy (30Gy in 10#) versus brachytherapy with external beam conditioning (EBRT 12Gy in 3# followed by weekly brachytherapy of 6 Gy weekly over 2 weeks) |
To compare dysphagia relief (change in grade of dysphagia) in radiation naïve esophageal cancer patients with high-grade dysphagia treated with external beam radiotherapy (30Gy in 10#) versus brachytherapy with external beam conditioning (EBRT 12Gy in 3# followed by weekly brachytherapy of 6 Gy weekly over 2 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of dysphagia relief, dysphagia-free survival, and overall survival |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A COMPARATIVE ANALYSIS OF DYSPHAGIA RELIEF WITH EXTERNAL BEAM RADIOTHERAPY VERSUS BRACHYTHERAPY WITH EXTERNAL BEAM CONDITIONING IN ADVANCED ESOPHAGEAL CANCER We aim to study difficulty in swallowing in advanced esophageal cancer patients between two arms of treatment modality, in which one treatment arm is treated with radiation therapy from outside (EBRT) alone, and the other arm is treated with radiation therapy from outside (EBRT) for few fractions to relieve dysphagia followed by inside (Brachytherapy). This study will be conducted at Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi. We will assess patients in terms of the score of dysphagia relief and duration of dysphagia relief in both arms via telephonic follow-up after radiation treatment and the assessment will be compared. |