Randomized Trial of Primary Surgery Followed Selective Radiochemotherapy for Rectal Cancer With MRI Negative CRM (PSSR)
Colorectal Neoplasm, Effects of Radiation Therapy, Effects of Chemotherapy
About this trial
This is an interventional treatment trial for Colorectal Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Rectal adenocarcinoma or mucinous adenocarcinoma that is 6-12 cm from the anal verge.
- MRI scan confirmed cT3N0 or cT4aN0 or cT1-4aN+ mid rectal cancer (6-12cm from the anal verge).
- MRI scan confirmed more than 1 mm circumferential margin.
- Age 18-75 years old.
- Without distant metastasis.
Exclusion Criteria:
- Malignant history.
- Contraindications of MRI scan.
- Contraindications of radiotherapy.
- Contraindications of chemotherapy.
- Pregnancy.
- Multidisciplinary team thinks that the patient is unsuitable to take part in research (For example, there are obvious regional lymph nodes involved in low rectal cancer patients who are thought with high risk of recurrence).
- Refuse to take part in research.
Sites / Locations
- Union Hospital Fujian Medical University
- Liaoning Cancer Hospital
- Zhongshan Hospital Fudan University
- The First Affiliated Hospital of College of Medicine Zhejiang University
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- Jinhua People's Hospital
- Yuyao People's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Primary surgery
Preoperative radiochemotherapy
The patients receive primary rectectomy including anterior resection or abdominoperineal resection by open or laparoscopy with TME. To patients with pathological confirmed positive circumferential margin (CRM), postoperative concurrent radiochemotherapy is required that starts in 3 months post operation with capecitabine. Capecitabine and Oxaliplatin (CapeOx) chemotherapy starts in 4 weeks post operation to total of 6 cycles/18 weeks. To patients with pathological confirmed negative CRM, radiotherapy is omitted. The stage III patients receive 8 cycles/6 months CapeOx chemotherapy. The stage II patients with low microsatellite instability (MSI) receive 8 cycles/6 months Capecitabine chemotherapy. The stage II patients with high MSI and stage I patients do not receive adjuvant therapy.
All of the patients receive conventional concurrent radiochemotherapy with capecitabine for 5 weeks. Then all of the patients receive 2 cycles/6 weeks capecitabine ± Oxaliplatin chemotherapy. Patients receive rectectomy including anterior resection or abdominoperineal resection by open or laparoscopy with total mesorectal excision 8 weeks post radiotherapy. All of the patients receive 5 cycles/15 weeks capecitabine ± Oxaliplatin adjuvant chemotherapy. The use of Oxaliplatin depends on the doctor's decision.