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

NCT03504449 | Unknown

• 1 other identifier: SCRM-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• circumferential resection margin

  one week after operation

• introperative perforation

  During the operation

Secondary Outcomes (4)

• local recurrece

  3 years after operation

• overal survival

  3 years after operation

• disease-free survival

  3 years after operation

• complications

  30 days after operation

Study Arms (2)

surgery without neoadjuvant chemoradiotherapy

EXPERIMENTAL

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

Other: neoadjuvant chemoradiotherapy

surgery with neoadjuvant chemoradiotherapy

EXPERIMENTAL

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

Other: neoadjuvant chemoradiotherapy

Interventions

neoadjuvant chemoradiotherapy OTHER

surgery with neoadjuvant chemoradiotherapy; surgery without neoadjuvant chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• With distant metastases
• With intestinal obstruction
• Pregnancy or lactation
• With operation contraindication
• With mental disorder

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Jiagang Han, MD

CONTACT

+861085231604; wzhj611@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of General Surgery

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: December 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

CN (1)