New treatment approach for advanced rectal cancer
Official title: 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
Run by Sun Yat-sen University · NCT05228431 · Data updated 2026-11-12
This study is testing a new treatment plan for people with advanced rectal cancer to see if a gentler approach can still be effective while causing fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 121 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | March 2, 2022 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | April 22, 2024 |
| Trial ID | NCT05228431 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 75 with confirmed rectal adenocarcinoma at clinical stage T3-4 or T any N1 without metastasis.
✕Probably not a fit
Patients with multiple primary tumors or those experiencing cachexia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates a modified sandwich therapeutic regimen for patients with locally advanced rectal cancer. The study aims to optimize the treatment by reducing the intensity of postoperative chemotherapy while still utilizing neoadjuvant chemoradiotherapy. The goal is to improve both short-term and long-term efficacy while minimizing the side effects associated with traditional treatment methods. Participants will receive a combination of XELOX, Capecitabine monotherapy, and radiation as part of their treatment plan.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced toxicity for patients with advanced rectal cancer.
How similar studies have gone: While traditional approaches have been used, this modified regimen represents a novel approach that has not been extensively tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion 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 Cachexy
Where it's running
-
Zhenhai Lu
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Zhenhai Lu, Prof
- Email: luzhh@sysucc.org.cn
- Phone: +862087343584
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.