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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 (SCRM-01)

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ClinicalTrials.gov Identifier: NCT03504449
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Circumferential Resection Margin Intraoperative Perforation of Rectum Local Recurrence of Malignant Tumor of Rectum Disease-free Survival Overal Survival Other: neoadjuvant chemoradiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: surgery without neoadjuvant chemoradiotherapy
For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy.
Other: neoadjuvant chemoradiotherapy
Experimental: surgery with neoadjuvant chemoradiotherapy
For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy.
Other: neoadjuvant chemoradiotherapy



Primary Outcome Measures :
  1. circumferential resection margin [ Time Frame: one week after operation ]
  2. introperative perforation [ Time Frame: During the operation ]

Secondary Outcome Measures :
  1. local recurrece [ Time Frame: 3 years after operation ]
  2. overal survival [ Time Frame: 3 years after operation ]
  3. disease-free survival [ Time Frame: 3 years after operation ]
  4. complications [ Time Frame: 30 days after operation ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504449


Contacts
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Contact: Jiagang Han, MD +861085231604 wzhj611@163.com

Locations
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China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Jiagang Han, Professor    8613522867841    hjg211@163.com   
Principal Investigator: Jiagang Han, Professor         
Principal Investigator: Zhenjun Wang, professor         
Sub-Investigator: Guanghui WEI, Professor         
Sponsors and Collaborators
Beijing Chao Yang Hospital

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Responsible Party: Zhen Jun Wang, Chairman of General Surgery, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT03504449     History of Changes
Other Study ID Numbers: SCRM-01
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Recurrence
Neoplasms
Rectal Neoplasms
Disease Attributes
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases