UnknownPhase 2

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

China200 participantsStarted 2018-10-23

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

R0(microscopically margin-negative) resection and cCR rate

Timeframe: 1-month after surgery completed

Trial details

NCT IDNCT03714490

SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Contact for this trial

Jing Jin, M.D.

86-010-87788503 jinjing@csco.org.cn

View on ClinicalTrials.gov More Rectal Neoplasms trials