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Search / Trial NCT05267275

Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Feb 23, 2022

Trial Information

Current as of July 04, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new surgical approach for patients with rectal cancer who have received preoperative treatment with radiation and chemotherapy. The goal is to see if an extended resection—removing more of the bowel above the tumor—can help reduce complications that may arise when connecting the remaining pieces of bowel after surgery. These complications can include leakage or narrowing at the connection site, which may happen if doctors use damaged bowel tissue.

To be eligible for this trial, participants should be between 18 and 75 years old and have mid-to-low rectal cancer that is not too far from the anus. They must have received specific preoperative treatments and be healthy enough to undergo surgery. Participants will have the chance to contribute to important research that could improve outcomes for future patients with similar conditions. Throughout the trial, they can expect close monitoring and care from the medical team to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus);
  • 2. The preoperative local stage is cT3-4N0-2M0 or cT3-4N0-2M1 (M1 is limited to liver metastases that can be surgically removed at the same time)
  • 3. Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
  • 4. Aged between 18-75 years old;
  • 5. ASA rating: 0-2
  • 6. ECOG Score: 0-2
  • 7. BMI 18-30 kg/m2;
  • 8. Radical surgical resection is expected to be possible on the basis of preserving the anus;
  • 9. Sign the informed consent document.
  • Exclusion Criteria:
  • 1. History of other malignant tumors;
  • 2. Emergency surgery patients;
  • 3. Severe underlying diseases, unable to tolerate surgery;
  • 4. Without informed consent.

About Qilu Hospital Of Shandong University

Qilu Hospital of Shandong University is a leading medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. Affiliated with Shandong University, the hospital integrates clinical practice with education and research, fostering an environment that promotes scientific discovery and the development of new therapies. With a commitment to high standards of clinical excellence and ethical research practices, Qilu Hospital plays a pivotal role in enhancing patient outcomes and contributing to the global medical community through a diverse range of clinical trials and studies.

Locations

Jinan, Shandong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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