Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients

Summary

Whether to perform radical TME or salvage chemoradiotherapy after local resection of intermediate-risk T1 rectal cancer is still controversial. A study based on the National Cancer Data Center showed that, because of the need for organ preservation, rescue chemoradiotherapy after local resection of rectal cancer was used in 10% of patients with T1N0 tumors and in 40% of patients with T2N0 tumors. However, the local recurrence caused by non-TME surgery is still the focus of concern for clinicians and patients. Previous retrospective studies have shown that there is no significant difference in overall survival and disease free survival between salvage CRT group and salvage TME group for patients with early rectal cancer after local resection. Pathological pT2 after local resection is the only independent risk factor for disease-free survival. However, limited to a single center and small sample size, the recurrence caused by salvage radiotherapy and chemotherapy should still be alert. Given these concerns, there is an urgent need to identify a better treatment regimen that can ensure reliable oncologic outcomes after local resection. Therefore, with TME as the control group and salvage chemoradiotherapy as the experimental group, we conducted a prospective, randomized, multicenter, non-inferiority clinical trial of the treatment effect of patients with intermediate-risk T1 and clinical stage N0M0 rectal cancer after local resection, to provide high-level evidence-based medical evidence for the final choice of these two salvage treatment methods.

Conditions

• Chemotherapy Effect
• Rectal Cancer

Interventions

PROCEDURE

Radical total mesorectal excision

Standard TME surgery was performed 3-4 weeks after local resection. The operation is roughly divided into the following steps:After abdominal exploration, gradually ligation and from the inferior mesenteric vessels, pay attention to protect the left ureter, reproductive blood vessels and upper abdominal nerve; The descending colon was fully mobilized and the splenic flexure was mobilized if necessary. Follow the principle of TME, perform sharp resection of the total mesorectum, and pay attention to the protection of the prostate, vagina, pelvic nerve, etc.For can be removed through double stapling technique in low former (LAR) need not inline sphincter resection (excluding cases), to must be inline sphincter resection can be turned to the anus operation (ditto), consistent way can choose according to the intraoperative situation drag anastomosis or manual suture or stapling anastomosis. Prophylactic loop colostomy of transverse colon or ileostomy is recommended.

OTHER

Salavge Adjuvant Chemoradiotherapy

Concurrent adjuvant chemotherapy:5-Fu or 5-Fu analogues based chemotherapy regimens were selected. CapeOx or capecitabine monotherapy or FOLFOX is recommended, and no more than 3 months.Adjuvant radiotherapy protocol:long-course radiotherapy protocol.a. Target definition: areas at high risk for recurrence of the primary tumor and regional lymphatic drainage.b. Radiotherapy technology: conventional radiotherapy, three-dimensional conformal radiotherapy, intensity modulated radiotherapy, image guided radiotherapy, etc.c. Radiation dose:DT of 45Gy,1.8Gy per fraction in 25 fractions, was recommended for the high-risk recurrence area of the primary tumor and the regional lymphatic drainage area.

Sponsors & Collaborators

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• China

Study Locations