Status:
UNKNOWN
Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients
Lead Sponsor:
Zhang Rui
Conditions:
Almost-cCR
Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almos...
Detailed Description
Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal oper...
Eligibility Criteria
Inclusion
- Histology is confirmed as rectal adenocarcinoma.
- 18 to 75 years old.
- Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.
- The anus couldn't be retained after TME.
- Almost-cCR or cCR recurrence during observation.
Exclusion
- Patients were unable to tolerate the operation.
- Preoperative stage: T4b or progress during the treatment.
- HIV infection stage or chronic hepatitis B.
- Active clinical severe infections.
- Evil liquid state or decompensation of organ function.
- Other malignant tumor history in five years.
- Other primary carcinoma.
- Unstable condition and incompliance of the patient
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT03431428
Start Date
January 1 2018
End Date
December 31 2022
Last Update
February 13 2018
Active Locations (1)
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1
Liaoning cancer Hospital
Shenyang, Liaoning, China