Clinical trial NCT06365866: Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer.
Official title: A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Neoplasms
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Neoplasms by Site
Gastrointestinal Diseases
Neoplasms
Keywords: Brachytherapy
Esophageal cancer
External beam radiotherapy
Intraluminal brachytherapy
Survival
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Add-on treatment to standard treatment (fixed doses allowing dose reduction or dose delay according to the tolerability of individual patients); No control group.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the safety and effectiveness of the add-on of intraluminal brachytherapy with BRAXX esophageal brachytherapy applicator after definitive CCRT in patients with thoracic esophageal cancer.

Detailed description: Add-on of intraluminal brachytherapy with applicator:

Brachytherapy protocol starts within 12 weeks after EBRT (This is "week 1"). High-dose-rate (HDR) 5-Gy per fraction is delivered to GTV of esophageal tumor(s), second fraction (if applicable) to be done within 2 weeks after the first fraction, for a total of 5-10Gy in 1-2 fractions. GTV coverage D90 should equal 100% of prescription. It is NOT allowed to give concurrent chemotherapy on the days of HDR brachytherapy.

* Prior to undergoing any study-specific procedure, patients must read and sign the current Ethics Committee/Institutional Review Board (IRB)-approved informed consent form. All on-study procedures are permitted within the visit window of ± 2 week. CT with contrast (no contrast if contraindicated) will be done at months 6 and 9; CT or PET/CT will be done at week 12 and month 12; and endoscopy with or without biopsy will be done at week 12, month 6, 9 and 12 for evaluation of tumor response; OPD follows up at week12, month 6, 9 and 12. A patient will be withdrawn from this study in the situation of any grade 4 toxicities. As for any adverse effects≧grade3, dose reduction, or dose delay according to the tolerability of individual patients is allowed. Grade 3 toxicity will cause the rest of the treatment (at least 1 week) until recovery to ≤grade 2 toxicity. If any patient can not tolerate a full course of brachytherapy, the total dose (EBRT+brachytherapy) can be reduced to 60Gy without violation of protocol. The management of adverse effects will follow general principles. Because tumor response is usually observed after completion of treatment, patients will not withdraw from the study because of no response. However, patients should be withdrawn from the study of (1) any grade 4 toxicity or (2) any unexpected cause of SAE that needs to discontinue radiation such as stroke, heart attack, accident, infection, bleeding...etc. Any failure observed during the post-treatment period will be documented, and patients should be withdrawn from the study, facilitating other treatment interventions.
* During this 12-month trial, any other cancer treatment (such as target therapy) and any non-cancer treatment that can increase adverse reactions within the treatment field are prohibited, so as not to affect treatment outcome or cause a change in side effects. The general management of symptoms or other non-cancer-related treatment is allowed, as long as physicians confirm that the interpretation of treatment outcome or side effects will not be influenced.
* The Investigator may use the data collected in this study for future research; which shall be consented by the Subject in the consent form.

Eligibility criteria: Inclusion Criteria:

* Age of 20-85 years, with ECOG performance 0-2.
* Thoracic esophageal cancer with clinical stage I-IV and biopsy proof; patient with stage I-IV cervical esophageal cancer could be recruited in this trial according to Investigator's assessment.
* Complete CCRT with total doses of 45-55Gy to GTV via external beam radiotherapy (EBRT).

Exclusion Criteria:

* According to Investigator's assessment, patients with double cancer or recurrence could be recruited in this trial if they continue to receive systemic therapy.
* Patient with double cancer, esophageal cancer or recurrence who is scheduled for surgery treatment.
* Involvement of tracheal mucosa or bronchial mucosa.
* Stenosis of esophageal lumen that cannot be bypassed by the applicator after EBRT.
* The distribution of the lesions of interest exceeds 10cm range.
* The patient is participating in other clinical trials.

Primary outcomes:
measure: To estimate the local control rate at primary tumor site.
timeFrame: 12 months after completion of treatment
Secondary outcomes:
measure: To estimate overall response rate.
timeFrame: 12 months after completion of treatment
measure: To estimate distant metastasis rate.
timeFrame: 12 months after completion of treatment
measure: To estimate progression-free survival rate.
timeFrame: 12 months after completion of treatment
measure: To estimate overall survival status.
timeFrame: 12 months after completion of treatment
measure: To estimate toxicity analysis.
timeFrame: 12 months after completion of treatment
measure: To estimate adverse event.
timeFrame: 3 months after completion of treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Pin-I Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: