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Completed

NCT Number: NCT05496270

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • emergency surgery due to bleeding, perforation, and bowel obstruction,
  • recurrent rectal cancer,
  • inflammatory bowel disease,
  • Stage IV.

Treatment and study plan

Total mesorectal excision

Procedure

Other names: neoadjuvant treatment

Primary outcomes

  1. 3-year diseases free survival

    Time frame: 3 years after surgery

Secondary outcomes

  1. Margin-free （R0）resection rate

    Time frame: Immediately after the surgery

  2. 3-year overall survival rate

    Time frame: 3 years after surgery

  3. Number of participants with surgical complications

    Time frame: 30 days after surgery

  4. Local recurrence rate

    Time frame: 3 years after the surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2022
First posted
Aug 11, 2022
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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