Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365866
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-02-26
Brief Title:
Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy CCRT for Local-regional Thoracic Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tumors 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 CommitteeInstitutional 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 PETCT 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week 12 month 6 9 and 12 for evaluation of tumor response OPD follows up at week12 month 6 9 and 12 A patient will be withdrawn from this study in the situation of any grade 4 toxicities As for any adverse effectsgrade3 dose reduction or dose delay according to the tolerability of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 EBRTbrachytherapy 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 bleedingetc 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
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 tumors 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 CommitteeInstitutional 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 PETCT 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 effectsgrade3 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 EBRTbrachytherapy 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 bleedingetc 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None