Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer

NCT ID: NCT05496270

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2022-08-31

Brief Summary

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Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Recently few studies have shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this study was designed to compare the long-term oncological outcomes between surgery and surgery following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TME

patients only underwent TME

total mesorectal excision

Intervention Type PROCEDURE

nCRT+TME

patients underwent TME following neoadjuvant treatment

total mesorectal excision

Intervention Type PROCEDURE

Interventions

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total mesorectal excision

Intervention Type PROCEDURE

Other Intervention Names

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neoadjuvant treatment

Eligibility Criteria

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Inclusion Criteria

1. Eighteen- to eighty-year-old patients.
2. T3 rectal cancer with clear mesorectal fascia (MRF),
3. within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI)

Exclusion Criteria

1. emergency surgery due to bleeding, perforation, and bowel obstruction,
2. recurrent rectal cancer,
3. inflammatory bowel disease,
4. Stage IV.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yanhong Deng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GIHSYSU-28

Identifier Type: -

Identifier Source: org_study_id

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