Actively Recruiting
Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer
Led by Zhen-Hai Lu · Updated on 2024-04-22
121
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed rectal adenocarcinoma
- Clinical stage T3-4 or any T with N1 lymph node involvement
- No distant metastasis
- No signs of intestinal obstruction, or obstruction relieved after proximal colostomy
- Age between 18 and 75 years
- No prior radiotherapy, surgery, or chemotherapy for rectal cancer
You will not qualify if you...
- Multiple primary tumors
- Cachexia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhenhai Lu
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Z
Zhenhai Lu, Prof
CONTACT
J
Jianhong Peng, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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