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

NCT06566222 | Not Yet Recruiting

• 1 other identifier: ChanghaiH-Radiotherapy
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2024

Study Arms (4)

NAT+High

Other: High-risk Factors

NAT+Low

PAT+High

Procedure: chemoradiotherapy after surgery; Other: High-risk Factors

PAT+Low

Interventions

chemoradiotherapy after surgery PROCEDURE

chemoradiotherapy after surgery vs preoperative chemoradiotherapy

Also known as: preoperative chemoradiotherapy

PAT+High

High-risk Factors OTHER

High-risk Factors vs low-risk Factors

Also known as: low-risk Factors

NAT+High; PAT+High

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with low- and medium-level rectal cancer treated with chemoradiotherapy and surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: August 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08