Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417476
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-04
Brief Title:
Short-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer
Sponsor:
Pei-Rong Ding
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Multicenter Open Randomized Phase II TrialShort-course Radiotherapy or Long-course Chemoradiation Followed by mFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Given the growing focus on preserving organ function and the utilization of neoadjuvant therapy it is important to investigate and enhance the application of comprehensive neoadjuvant therapy in low rectal cancer This approach aims to improve disease-free survival DFS while minimizing or circumventing the organ dysfunction and subsequent decline in quality of life associated with radical surgery Consequently we propose to initiate a multicenter clinical trial to examine the medium- and long-term effectiveness of complete neoadjuvant therapy comprising either short-course radiotherapy or long-course chemoradiation followed by consolidation chemotherapy with mFOLFOXIRI in increasing organ preservation rates in patients with low rectal cancer
Detailed Description:
This randomised open-label multicentrephase II trial began in December 2022 as a neoadjuvant trial about short-course radiotherapy or long-course chemoradiation followed by mFOLFOXIRI consolidation chemotherapyin patients aged 18 years to 70 with clinical stage II-III locally advanced low rectal cancer from six Chinese institutions
Patients with local advanced rectal cancer cT2-4aN0-2M0 8cm from the anus verge were recruited Patients receive short-course radiotherapy 25Gy5 times followed by consolidation chemotherapy lor ong-course chemoradiation 50Gy25 timescapecitabine 825 mgm² twice daily with mFOLFOXIRI Irinotecan 150 mgm2 iv gtt 2h d1 Oxaliplatin 85 mgm2 iv gtt 2h d1 Calcium folinate 400 mgm2 iv gtt 2h d1 Total amount of fluorouracil 2400 mgm2 iv gtt 48h treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity The first efficacy evaluation occurs after the fourth chemotherapy cycle Patients showing a complete response CR partial response PR or stable disease SD with reduction or stability in tumor size are advised to continue and complete all planned consolidation chemotherapy However if the evaluation indicates stable disease with an increase SD increased or progressive disease PD and if an R0 resection complete removal of the tumor with no cancer cells at the margins is feasible radical total mesorectal excision TME should be pursued In cases where R0 resection is not achievable the treatment should align with the guidelines for managing unresectable rectal cancer Upon the final efficacy assessment after the eighth chemotherapy cycle several pathways are considered based on the outcomes patients achieving a clinical complete response cCR may proceed to a Watch Wait approach Those with a near clinical complete response near cCR undergo local transanal resection If the patients condition is evaluated as PRSD with a reduction but does not qualify as near cCR radical TME is recommended For patients showing SD with an increase or PD yet with a potential for R0 resection radical TME is again the suggested course of action If R0 resection is unattainable treatment should adhere to the guidelines for unresectable rectal cancer
Patients with local advanced rectal cancer cT2-4aN0-2M0 8cm from the anus verge were recruited Patients receive short-course radiotherapy 25Gy5 times followed by consolidation chemotherapy lor ong-course chemoradiation 50Gy25 timescapecitabine 825 mgm² twice daily with mFOLFOXIRI Irinotecan 150 mgm2 iv gtt 2h d1 Oxaliplatin 85 mgm2 iv gtt 2h d1 Calcium folinate 400 mgm2 iv gtt 2h d1 Total amount of fluorouracil 2400 mgm2 iv gtt 48h treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity The first efficacy evaluation occurs after the fourth chemotherapy cycle Patients showing a complete response CR partial response PR or stable disease SD with reduction or stability in tumor size are advised to continue and complete all planned consolidation chemotherapy However if the evaluation indicates stable disease with an increase SD increased or progressive disease PD and if an R0 resection complete removal of the tumor with no cancer cells at the margins is feasible radical total mesorectal excision TME should be pursued In cases where R0 resection is not achievable the treatment should align with the guidelines for managing unresectable rectal cancer Upon the final efficacy assessment after the eighth chemotherapy cycle several pathways are considered based on the outcomes patients achieving a clinical complete response cCR may proceed to a Watch Wait approach Those with a near clinical complete response near cCR undergo local transanal resection If the patients condition is evaluated as PRSD with a reduction but does not qualify as near cCR radical TME is recommended For patients showing SD with an increase or PD yet with a potential for R0 resection radical TME is again the suggested course of action If R0 resection is unattainable treatment should adhere to the guidelines for unresectable rectal cancer
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