Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial (SCRM-01)

Capital Medical University

Status: Unknown

Conditions: Local Recurrence of Malignant Tumor of Rectum; Disease-free Survival; Circumferential Resection Margin; Overal Survival; Intraoperative Perforation of Rectum

Treatments: Other: neoadjuvant chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03504449

SCRM-01

Details and patient eligibility

About

For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Tumor within 12 cm of the anal verge
2. T3N1-2 as determined by preoperative MRI examination
3. negative circumferential resection margin determined by preoperative MRI examination
4. Absence of distant metastases
5. Absence of intestinal obstruction

Exclusion criteria

1. With distant metastases
2. With intestinal obstruction
3. Pregnancy or lactation
4. With operation contraindication
5. With mental disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

350 participants in 2 patient groups

surgery without neoadjuvant chemoradiotherapy

Experimental group

Description:

For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy.

Treatment:

Other: neoadjuvant chemoradiotherapy

surgery with neoadjuvant chemoradiotherapy

Experimental group

Description:

For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy.

Treatment:

Other: neoadjuvant chemoradiotherapy