Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06566222
Enrollment
2000
Registered
2024-08-22
Start date
2024-08-25
Completion date
2024-12-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapy

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

Interventions

PROCEDUREchemoradiotherapy after surgery

chemoradiotherapy after surgery vs preoperative chemoradiotherapy

OTHERHigh-risk Factors

High-risk Factors vs low-risk Factors

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Overall survival2024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026