Status:
NOT_YET_RECRUITING
Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
Lead Sponsor:
Changhai Hospital
Conditions:
Radiotherapy
Eligibility:
All Genders
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 25 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06566222
Start Date
August 25 2024
End Date
December 31 2024
Last Update
August 22 2024
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