- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05228431
Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer
Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Zhenhai Lu, Prof
- Phone Number: +862087343584
- Email: luzhh@sysucc.org.cn
Study Contact Backup
- Name: Jianhong Peng, M.D
- Phone Number: +862087343584
- Email: pengjh@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Zhenhai Lu
-
Sub-Investigator:
- Zhifan Zeng, M.D
-
Contact:
- Zhenhai Lu, Prof
- Phone Number: +86 20 87343584
- Email: luzhh@sysucc.org.cn
-
Contact:
- Jianhong Peng, Doctor
- Phone Number: +86 20 87343584
- Email: pengjh@sysucc.org.cn
-
Sub-Investigator:
- Xiaojun Wu, M.D
-
Sub-Investigator:
- Junzhong Lin, M.D
-
Sub-Investigator:
- Rongxin Zhang, M.D
-
Sub-Investigator:
- Weiwei Xiao, M.D
-
Sub-Investigator:
- Yujing Fang, Ph.D
-
Sub-Investigator:
- Fulong Wang, M.D
-
Sub-Investigator:
- Jianhong Peng, M.D
-
Sub-Investigator:
- Yuan Li, M.D
-
Sub-Investigator:
- Qingjian Ou, M.D
-
Sub-Investigator:
- Weili Zhang, M.D
-
Sub-Investigator:
- Jiali Chen, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Pathological confirmed rectal adenocarcinoma.
Clinical stage T3-4 or T any N1.With or without MRF positivity, with or without EMVI positivity, R0 resection is estimated.
No metastasis
No signs of intestinal obstruction; or intestinal obstruction has been relieved after proximal colostomy surgery.
Age ranged from 18 to 75
No previous radiotherapy,surgery and chemotherapy.
Exclusion Criteria:
Multiple primary tumor
Cachexy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
|
Starting from the first day of radiotherapy (set as day 0), the patient received a total of 4 courses of XELOX chemotherapy on days -42, -21, 42, and 63, including oxaliplatin 130 mg/m2, intravenous administration, d1, repeat every 3 weeks; and capecitabine 1000mg/m2, twice daily, d1-d14, repeat every 3 weeks.
During radiotherapy (Monday to Friday), capecitabine was administered at 1650 mg/m2/d, twice a day.
The TV is expanded by 6-7mm to form PTV1, and the CTV is expanded by 6-7mm to form PTV2. The dose of PTV1 was 50Gy/25 times/35 days, and the dose of PTV2 was 45Gy/25 times/35 days, 5 times/week for a total of 5 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of pCR
Time Frame: One week after surgery
|
rate of pathological complete remission
|
One week after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 5 years
|
overall survival
|
5 years
|
DFS
Time Frame: 3 years
|
Disease free survival
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
Other Study ID Numbers
- 2021-FXY-494-Department of CRC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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