Surgery for rectal cancer after chemotherapy and radiation
Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
NA · Sixth Affiliated Hospital, Sun Yat-sen University · NCT02649647
This study is testing a new type of surgery for rectal cancer patients who have had chemotherapy and radiation to see if it helps them have better bowel function and fewer complications after the operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02649647 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of proximally extended resection compared to conventional resection in patients with rectal cancer who have undergone neoadjuvant chemoradiotherapy. The study aims to determine whether this surgical approach can improve postoperative bowel function and reduce complications such as anastomotic leakage. Eligible participants include adults aged 18-75 with specific tumor characteristics and no evidence of distant metastasis. The trial is conducted at the Sixth Affiliated Hospital of Sun Yat-sen University and involves collaboration with other prominent medical institutions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with locally advanced rectal cancer who are undergoing neoadjuvant chemoradiotherapy and are suitable for sphincter-preserving surgery.
Not a fit: Patients with prior colorectal resections, distant metastasis, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance bowel function and reduce complications for rectal cancer patients undergoing surgery after chemoradiotherapy.
How similar studies have performed: While the specific approach of proximally extended resection is novel, similar studies have shown promise in improving surgical outcomes for rectal cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-75 years old * ECOG performance status: 0-2 * Histologically confirmed adenocarcinoma of the rectum * Distal border of the tumor located ≤ 12 cm from the anal verge * Primary stage T3-4 or any node-positive disease * Undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy * Conventional fractionated radiotherapy of at least 45 Gy * Resectable disease after neoadjuvant chemoradiotherapy * No evidence of distant metastasis * Amenable to sphincter-preserving surgery * Tolerable to general anesthesia * Provision of written informed consent Exclusion Criteria: * Prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix * Synchronous colon cancer * History of colorectal resection except appendectomy * Acute intestinal obstruction or perforation * Multiple visceral resection * Abdominoperineal resection * American Society of Anesthesiologists (ASA) class Ⅳ or Ⅴ * Pregnant or nursing, fertile patients do not use effective contraception * Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease * Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Hui Wang, M.D. — Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Qiyuan Qin, M.D.
- Email: qinqy3@mail.sysu.edu.cn
- Phone: 86-20-38254052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer, Rectal cancer, Neoadjuvant therapy, Chemoradiotherapy, Resection margin, Bowel function, Anastomosis