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
Overview
- Phase
- Phase 2
- Intervention
- XELOX
- Conditions
- Advanced Rectal Cancer
- Sponsor
- Zhen-Hai Lu
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Rate of pCR
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.
Investigators
Zhen-Hai Lu
Pofessor
Sun Yat-sen University
Eligibility Criteria
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
Arms & Interventions
Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
Intervention: XELOX
Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
Intervention: Capecitabine monotherapy
Sandwich Regimen
All rectal patients in this group will receive standard surgical resection.
Intervention: Radiation
Outcomes
Primary Outcomes
Rate of pCR
Time Frame: One week after surgery
rate of pathological complete remission
Secondary Outcomes
- OS(5 years)
- DFS(3 years)