Individualized treatment for rectal cancer using chemoradiotherapy based on recurrence risk

A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

This study is testing a personalized treatment plan using MRI to help patients with stage II and III rectal cancer get the right combination of chemotherapy and radiation before surgery to improve their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: ChineseAMS
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT04664504 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with locally advanced rectal cancer, utilizing rectal MRI to assess recurrence risk and tailor neoadjuvant chemoradiotherapy accordingly. The approach aims to improve surgical outcomes by increasing the R0 resection rate and enhancing disease-free survival. Patients will receive a combination of radiotherapy and chemotherapy before undergoing radical surgery, with treatment plans individualized based on MRI findings. The study specifically targets stage II and III rectal cancer patients to optimize their treatment strategy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed stage II or III rectal adenocarcinoma.

Not a fit: Patients with a history of other malignancies, severe comorbidities, or contraindications to the treatment regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced recurrence rates for rectal cancer patients.

How similar studies have performed: Other studies have shown promise in using MRI for treatment stratification in rectal cancer, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Rectal adenocarcinoma confirmed by histopathology
2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)
3. The age is 18-75 years old, no gender limit

3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score ≥ 80 or ECOG score 0-1

Exclusion Criteria:

1. History of other malignant tumors;
2. They were allergic to 5-FU, platinum, etc;
3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;
4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal;
5. History of gastrointestinal fistula, perforation or severe ulcer;
6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) ≥ grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease ≥ grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.

Where this trial is running

Beijing

• Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yuan Tang, M.D.

Conditions Rectal Cancer; Neoadjuvant Chemoradiotherapy; Recurrence Risk