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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03504449
Acronym
SCRM-01
Enrollment
350
Registered
2018-04-20
Start date
2016-12-01
Completion date
2022-12-01
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERneoadjuvant chemoradiotherapy

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
circumferential resection marginone week after operation
introperative perforationDuring the operation

Secondary

MeasureTime frame
local recurrece3 years after operation
overal survival3 years after operation
disease-free survival3 years after operation
complications30 days after operation

Countries

China

Contacts

Primary ContactJiagang Han, MD
wzhj611@163.com+861085231604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026