Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy

Not Applicable

• Conditions: Rectum Cancer
• Interventions: Procedure: TME; Drug: neoadjuvant CT; Radiation: Concurrent chemo-radiotherapy; Drug: adjuvant CT

• Registration Number: NCT03071198
• Lead Sponsor: Harbin Medical University

Brief Summary

Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer

Detailed Description

By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.

Study Timeline

• Study First Submitted: 2017-02-26
• Status Verified: 2017-03
• Study Start: 2017-03-01
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-06
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07
• Primary Completion: 2018-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Preoperative neoadjuvant CT-RCT	adjuvant CT	Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Preoperative neoadjuvant CT	neoadjuvant CT	Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Concurrent chemo-radiotherapy	TME	Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Preoperative neoadjuvant CT	TME	Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Preoperative neoadjuvant CT-RCT	TME	Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Preoperative neoadjuvant CT	adjuvant CT	Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Preoperative neoadjuvant CT-RCT	Concurrent chemo-radiotherapy	Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Preoperative neoadjuvant CT-RCT	neoadjuvant CT	Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Concurrent chemo-radiotherapy	Concurrent chemo-radiotherapy	Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy
Concurrent chemo-radiotherapy	adjuvant CT	Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy

Primary Outcome Measures

Name	Time	Method
Disease Free Survival (DFS)	3 years	the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.

Secondary Outcome Measures

Name	Time	Method
Surgery related mortality and complication	3 years	Surgery related mortality and complication
Tolerance after neoadjuvant treatment	3 years	Tolerance after neoadjuvant treatment
Predictor efficacy of neoadjuvant chemotherapy for DFS	3 years	Predictor efficacy of neoadjuvant chemotherapy for DFS
Resection rate of R0	3 years	Resection rate of R0
Pathologic complete remission (pCR) rate	3 years	Pathologic complete remission (pCR) rate

Trial Locations

Locations (1)

Cancer Hospital Affiliated to Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China