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

N

Naval Military Medical University

Status

Not yet enrolling

Conditions

Radiotherapy

Treatments

Procedure: chemoradiotherapy after surgery
Other: High-risk Factors

Study type

Observational

Funder types

Other

Identifiers

NCT06566222
ChanghaiH-Radiotherapy

Details and patient eligibility

About

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

Enrollment

2,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. The patient is between 18 and 80 years old;
  2. Adenocarcinoma confirmed by pathology;
  3. Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin is ≤10cm;
  4. 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

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

Trial design

2,000 participants in 4 patient groups

NAT+High
Treatment:
Other: High-risk Factors
NAT+Low
PAT+High
Treatment:
Other: High-risk Factors
Procedure: chemoradiotherapy after surgery
PAT+Low

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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