Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353685
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-03-23
Brief Title:
De-Escalation Postoperative Radiotherapy for Oral Squamous Cell Carcinoma With pCRMPR
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Phase II Clinical Study of Continuous Hyperfractionated Accelerated RadiotherapyCHART in Oral Cancer Patients Who Underwent Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR and MPR After Surgery
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 prognosis of locally advanced oral squamous cell carcinomaOSCC is poor and there are still many problems to be solved in the current treatment paradigm Neoadjuvant chemotherapy combined with immunotherapy can significantly improve the pCR and MPR rates in patients with locally advanced OSCC For patients who achieve pCR and MPR after neoadjuvant therapy and surgery it is still hotly debated regarding whether to implement postoperative de-escalation radiotherapy Neoadjuvant therapy is an ideal predictor of radiosensitivity In theory neoadjuvant therapy can eliminate microscopic lesions thereby reducing the dose and volume of irradiation
Continuous hyperfractionated accelerated radiotherapy CHART based on hyperfractionated radiotherapy increasing daily or weekly treatments and shortening the total treatment duration but reducing the total dose is to give a higher dose of radiation to tumor tissue in a shorter period of time so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells It is beneficial to improve the local control rate of tumor control the acute injury of normal tissue and the yield acceptable late treatment-related complications The specific protocol was as follows high-risk CTV area CTV1 45Gy in total fraction dose of 15Gy twice a day bioequivalent dose BED of 5175Gy Low-risk CTV areaCTV2 39Gy in total fraction dose of 13Gy twice a day BED of 4407Gy A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks
Continuous hyperfractionated accelerated radiotherapy CHART based on hyperfractionated radiotherapy increasing daily or weekly treatments and shortening the total treatment duration but reducing the total dose is to give a higher dose of radiation to tumor tissue in a shorter period of time so as to overcome the accelerated reproliferation and inhibit the repair of sublethal damage of tumor cells It is beneficial to improve the local control rate of tumor control the acute injury of normal tissue and the yield acceptable late treatment-related complications The specific protocol was as follows high-risk CTV area CTV1 45Gy in total fraction dose of 15Gy twice a day bioequivalent dose BED of 5175Gy Low-risk CTV areaCTV2 39Gy in total fraction dose of 13Gy twice a day BED of 4407Gy A total of 30 radiotherapy fraction were performed 10 times a week for 3 weeks
Detailed Description:
None
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