Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified
Conditions
Interventions
Intervention1: 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.
Control Intervention1: 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
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 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
| Measure | Time frame |
|---|---|
| To compare the duration of dysphagia relief, dysphagia-free survival, and overall survivalTimepoint: 18 months | — |
Countries
India
Contacts
Public ContactShreya jain
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi
Outcome results
None listed