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Clinical Trials/NCT06566222
NCT06566222
Not yet recruiting
Not Applicable

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

Changhai Hospital0 sites2,000 target enrollmentAugust 25, 2024
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ConditionsRadiotherapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiotherapy
Sponsor
Changhai Hospital
Enrollment
2000
Primary Endpoint
Overall survival
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 25, 2024
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Overall survival

Time Frame: 2024

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