RecruitingPhase 2NCT03714490

MRI Simulation-guided Boost in Short-course Preoperative 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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

200 participants

Start Date

Oct 23, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding an extra targeted radiation boost — guided by MRI imaging — to a short-course radiation treatment before surgery can improve outcomes for patients with advanced rectal cancer (cancer of the lower bowel) that is difficult to remove due to its closeness to surrounding structures. **You may be eligible if...** - You have been diagnosed with rectal cancer (adenocarcinoma) confirmed by biopsy - The tumor is located within 10 cm of the anal opening - Your cancer is locally advanced (T3, T4, or spread to nearby lymph nodes), confirmed by MRI - You have not yet received any treatment (surgery, chemotherapy, or radiation) for this cancer - Your blood counts and organ function meet minimum thresholds - You are well enough to receive chemotherapy (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastases) - Your rectal cancer has come back after prior treatment - You have active Crohn's disease or ulcerative colitis - You are allergic to fluorouracil or platinum-based drugs - You cannot have an MRI - You are pregnant or breastfeeding - You have symptoms of numbness or nerve damage in your hands or feet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSCPRT

Short-course preoperative radiotherapy(SCPRT), which consists of 5 Gy x 5f and 4Gy for boost on the GTV with MRI-simulation alone.

RADIATIONCRT

Long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively.

DRUGCAPOX

Patients will receive consolidation chemotherapy after 7-10 days of SCPRT completed, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are scheduled before surgery.


Locations(1)

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, China

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NCT03714490


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