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Clinical Trials/NCT06566222
NCT06566222Not yet recruitingNot 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 enrollmentStarted: August 25, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
2,000
Primary Endpoint
Overall survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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