MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Oct 19, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat patients with advanced rectal cancer that cannot be surgically removed. The researchers want to see if using MRI scans to guide a higher dose of radiation, combined with a shorter treatment time and followed by chemotherapy, can help shrink the tumor more effectively than traditional methods. The hope is that this approach will improve the chances of making the cancer smaller before surgery.

To be eligible for the trial, participants must have a confirmed diagnosis of rectal cancer that is locally advanced and located within 10 centimeters of the anal opening. They should be generally healthy, able to provide written consent, and not have received any anti-cancer treatments after their diagnosis. Participants will undergo the new treatment and will be monitored closely to evaluate its effectiveness and side effects. This trial is currently recruiting participants aged between 18 and 75, and both men and women can join.

Gender

ALL

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