To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery

NCT05145647 | Active Not Recruiting

• 1 other identifier: 202100288A3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical experience of adding intraluminal brachytherapy with traditional applicator after definitive concurrent chemoradiotherapy (CCRT) for local-regional thoracic esophageal cancer is limited due to high complication risk and non-superiority in survival. The innovative applicator can maximize the therapeutic efficacy by reducing dose inhomogeneity in the esophageal wall, which will translate into less over-dosing and less risk of the side effects of fistula or stenosis. The primary goal of this study by using new applicator is to observe the change in local tumor control rate, while secondary goals are treatment related toxicity, progression-free survival, and overall survival.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• To estimate the local control rate at primary tumor site

  Enrolled subject will be followed every 3 months after treatment, EGD-endoscope (± biopsy) will be arranged at Month 3, 6, 9, 12 and CT scans on Month 6, 12, to evaluate the tumor status.

  12 months after completion of treatment

Secondary Outcomes (1)

• Treatment toxicity grading according to the CTCAE

  12 months after completion of treatment

Other Outcomes (2)

• Progression-free survival (PFS)

  12 months after completion of treatment

• Overall survival (OS)

  12 months after completion of treatment

Study Arms (1)

Add-on Brachytherapy

EXPERIMENTAL

The evaluation for feasibility of surgery takes place 5-6 weeks after CCRT. Any subject whose tumor status is resectable at evaluation but declines surgical proposal will be eligible to be enrolled in the following study phase.

Radiation: Add-on Brachytherapy; Device: "BRAXX" Esophageal Brachytherapy Applicator

Interventions

Add-on Brachytherapy RADIATION

Brachytherapy protocol starts within 2 weeks after consolidative EBRT, subjects who are enrolled will receive brachytherapy with specified balloon applicator. High-dose-rate (HDR) brachytherapy system will be used in the treatment, 5-Gy per fraction is delivered to the pre-treatment esophageal length of primary tumor(s), second treatment if applicable will be finished within 2 weeks after the first one, a total of 5-10Gy in 1-2 fractions will be delivered.

Add-on Brachytherapy

"BRAXX" Esophageal Brachytherapy Applicator DEVICE

The device is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.

Also known as: 510(K) Number: K183332 (class II)

Add-on Brachytherapy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 20-85 years, with ECOG performance 0-2
• Thoracic esophageal cancer with clinical stage I-III and biopsy proof; patient with cervical esophageal cancer or stage IV thoracic esophageal cancer could be recruited in this trial according to Investigator's assessment.
• Complete first course CCRT with minimum doses of 40 Gy to tumor and nodal area via external beam radiotherapy (EBRT).
• Patient whose tumor is resectable but declined to receive surgery after first course CCRT.

You may not qualify if:

• T4b tumor status (tracheal / bronchial mucosa, aortic involvement, or fistula formation).
• Stenosis of esophageal lumen that cannot be bypassed by the applicator.
• The primary tumor length exceeds 20cm.
• The patient is participating in other clinical trials.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, 33305, Taiwan

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Chen-Kan Tseng, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: December 6, 2021
• Study Start: March 30, 2022
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): October 18, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Locations

TW (1)