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NCT Number: NCT06566222

Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors

The purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage II/III low- and medium-level rectal cancer with or without high-risk factors

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The patient is between 18 and 80 years old;
  • Adenocarcinoma confirmed by pathology;
  • Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin is ≤10cm;
  • ECOG score ≤2

(4) Imaging diagnostic analysis was cT1-3NxM0; (for Phase II/III) (5) CT examination of the chest and abdomen and pelvis showed no evidence of metastasis (6) Patients undergoing chemoradiotherapy and surgery

Exclusion criteria

  • History of malignant tumors in the past;
  • Diagnosis of simultaneous multiple primary colorectal cancer or other cancers;
  • History of chemotherapy or radiotherapy prior to this trial
  • Those with contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;
  • Pregnant or lactating women;
  • Evidence of distant metastases prior to surgery
  • T4b tumors were found to invade the uterus, vagina, bladder, seminal vesicles, prostate, bone, and pelvic plexus

Treatment and study plan

chemoradiotherapy after surgery

Procedure

chemoradiotherapy after surgery vs preoperative chemoradiotherapy

Other names: preoperative chemoradiotherapy

High-risk Factors

Other

High-risk Factors vs low-risk Factors

Other names: low-risk Factors

Primary outcomes

  1. Overall survival

    Time frame: 2024

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

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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