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

Not yet recruiting

• Conditions: Radiotherapy
• Interventions: Procedure: chemoradiotherapy after surgery; Other: High-risk Factors

• Registration Number: NCT06566222
• Lead Sponsor: Changhai Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Study Start: 2024-08-25
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAT+High	High-risk Factors	-
PAT+High	chemoradiotherapy after surgery	-
NAT+High	High-risk Factors	-

Primary Outcome Measures

Name	Time	Method
Overall survival	2024