NCT05228431RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 121 (estimated)
- First submitted
- 22 Jan 2022
- Start date
- 2 Mar 2022
- Primary completion date
- 1 May 2027
- Lead sponsor
- Zhen-Hai Lu
- Diseases
- Colorectal cancer
- NCT number
- NCT05228431
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 121
- From 2 Mar 2022 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Multiple primary tumor
- Cachexy
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhenhai Lu Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.