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

Summary

Improvements in downstaging are required when using preoperative chemoradiation for unresectable rectal cancer. There is therefore a need to explore more effective schedules. The study arm will receive MRI simulation-guided boost in short-course preoperative radiotherapy followed by consolidation chemotherapy , which may enhance the shrinkage of tumor comparing with the concurrent chemoradiation.

Eligibility

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

Conditions2

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