Status:
UNKNOWN
Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. H...
Eligibility Criteria
Inclusion
- Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus);
- 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)
- Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
- Aged between 18-75 years old;
- ASA rating: 0-2
- ECOG Score: 0-2
- BMI 18-30 kg/m2;
- Radical surgical resection is expected to be possible on the basis of preserving the anus;
- Sign the informed consent document.
Exclusion
- History of other malignant tumors;
- Emergency surgery patients;
- Severe underlying diseases, unable to tolerate surgery;
- Without informed consent.
Key Trial Info
Start Date :
November 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05267275
Start Date
November 30 2021
End Date
December 1 2025
Last Update
March 4 2022
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012