Comparing short-term radiotherapy with chemotherapy to long-term chemoradiotherapy for rectal cancer

Phase III Study of Short-term Radiotherapy Plus Neoadjuvant Chemotherapy Versus Preoperative Long-term Chemoradiotherapy in Locally Advanced Rectal Cancer

This study is testing whether a shorter course of radiation combined with chemotherapy can help people with locally advanced rectal cancer do better than the longer treatment of chemotherapy and radiation before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: ChineseAMS
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT02533271 on ClinicalTrials.gov

What this trial studies

This phase III randomized multicenter trial aims to evaluate the effectiveness of short-term radiotherapy combined with neoadjuvant chemotherapy against preoperative long-term chemoradiotherapy in patients with locally advanced rectal cancer. The primary endpoint is the 3-year disease-free survival rate, which will be assessed by monitoring local-regional failures, distant metastasis, second primary tumors, and overall mortality. The study plans to enroll 600 patients, with a focus on ensuring statistical rigor and timely evidence generation through careful monitoring of outcomes and toxicity profiles.

Who should consider this trial

Good fit: Ideal candidates include individuals with biopsy-proven rectal adenocarcinoma located within 10 cm of the anal verge and classified as locally advanced.

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

Why it matters

Potential benefit: If successful, this study could provide a more effective preoperative treatment option for patients with locally advanced rectal cancer, potentially improving their survival rates.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of treatment modalities is novel.

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+)
* Cancer Staging must be based on 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, Beijing

• Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yuan Tang

Conditions Cancer, Rectum; rectal cancer; short-term radiotherapy; neoadjuvant chemotherapy; total mesorectal excision