MRI-guided short-course radiotherapy for unresectable rectal cancer

MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy (SCPRT) Followed by Consolidation Chemotherapy Versus Long Course Chemoradiation for Unresectable Rectal Cancer

This study is testing a new type of short radiation treatment followed by chemotherapy to see if it helps people with advanced rectal cancer who can’t have surgery, compared to the usual longer treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT03714490 on ClinicalTrials.gov

What this trial studies

This phase II trial aims to evaluate the effectiveness of MRI simulation-guided short-course preoperative radiotherapy followed by consolidation chemotherapy in patients with unresectable locally advanced rectal cancer. Participants will be randomized into two groups: one receiving the experimental treatment and the other receiving standard long-term chemoradiotherapy. The primary goal is to assess the rate of R0 resection and clinical complete response, while secondary objectives include evaluating survival rates, toxicity profiles, and quality of life over a follow-up period of three to five years. Additionally, the study will explore biomarkers for treatment response and survival prediction.

Who should consider this trial

Good fit: Ideal candidates are individuals with biopsy-proven locally advanced rectal adenocarcinoma located within 10 cm of the anal verge and who meet specific health criteria.

Not a fit: Patients with distant metastases, recurrent rectal cancer, or active Crohn's disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve tumor shrinkage and surgical outcomes for patients with unresectable rectal cancer.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific methodology is being explored in a novel context.

Eligibility criteria

Inclusion Criteria:

* Biopsy proven rectal adenocarcinoma;
* Distance between tumour and anal verge≤ 10cm;
* Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+)
* Mesorectal fascia(MRF)+ or T4b evaluated by pelvic MRI;
* Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
* Written informed consent;
* Mentally and physically fit for chemotherapy;
* Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL）
* No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis.

Exclusion Criteria:

* Distant metastases;
* Recurrent rectal cancer;
* Active Crohn's disease or ulcerative colitis;
* Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma)
* Allergic to Fluorouracil or Platinum drugs;
* Contraindications to MRI for any reason;
* Concurrent uncontrolled medical condition;
* Pregnancy or breast feeding;
* Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract;
* Symptoms or history of peripheral neuropathy

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: Jing Jin, M.D.

Conditions Rectal Neoplasms; rectal cancer; short-term radiotherapy; neoadjuvant chemotherapy; total mesorectal excision; MRI-simulation; boost