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Not yet recruiting NCT06566222

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

Observational Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: chemoradiotherapy after surgery, High-risk Factors.
Who it may be relevant to
Registry conditions: Radiotherapy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Procedure chemoradiotherapy after surgery
    chemoradiotherapy after surgery vs preoperative chemoradiotherapy
  • Other High-risk Factors
    High-risk Factors vs low-risk Factors

Primary outcome measures

  • Overall survival [Time frame: 2024]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06566222 · ChanghaiH-Radiotherapy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗