New treatment approach for 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
PHASE2 · Sun Yat-sen University · NCT05228431
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 121 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05228431 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with multiple primary tumors or those experiencing cachexia may not benefit from this study.
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 performed: While traditional approaches have been used, this modified regimen represents a novel approach that has not been extensively tested in previous studies.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Zhenhai Lu — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Zhenhai Lu, Prof
- Email: luzhh@sysucc.org.cn
- Phone: +862087343584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Rectal Cancer, Rectal cancer, neoadjuvant chemoradiotherapy, optimization