Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Almost-cCR
- Rectal Cancer
- Surgery
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recur...
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 operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy?ypT3? in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up?the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.
Tracking Information
- NCT #
- NCT03431428
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: peirong ding, doctor Sun Yat-sen University Principal Investigator: ji zhu, doctor Fudan University Principal Investigator: zhenning wang, doctor First Hospital of China Medical University Principal Investigator: hong zhang, doctor Shengjing Hospital Principal Investigator: yu han, doctor Harbin Medical University Principal Investigator: zhaocheng chi, doctor Jilin Provincial Tumor Hospital Principal Investigator: quan wang, doctor The First Hospital of Jilin University Principal Investigator: ge liu, doctor The First Affiliated Hospital of Dalian Medical University Principal Investigator: hang lu, doctor The First People's Hospital of Jingzhou Principal Investigator: zheng liu, doctor Cancer Institute and Hospital, Chinese Academy of Medical Sciences Study Director: rui Zhang, doctor Liaoning Tumor Hospital & Institute
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