Back to resultsNeoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy
Primary Purpose
Neoadjuvant Treatment, Rectal Cancer, Bevacizumab
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bevacizumab+mFOLFOX6
Sponsored by
About this trial
This is an interventional treatment trial for Neoadjuvant Treatment
Eligibility Criteria
Inclusion Criteria:
- A biopsy proven histological diagnosis of rectal adenocarcinoma；
- An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High;
- No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
- MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
- Age between 18-75 years;
- ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
Has sufficient organ function:
- Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L,
- neutrophils ≥ 1.5 × 109/L
- Liver function: ALT and AST < 2.5 × ULN;
- Renal function: serum creatinine < 1.5 ULN;
- Willing to participate and informed consent signed；
Exclusion Criteria:
- An ARMS-PCR proven RAS wild type, BRAF mutation and microsatellite instablility-High;
- Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
- Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
- Female patients who are pregnant or breastfeeding;
- Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
- Patients with active infection;
- Poor overall health status, ECOG ≥ 2;
- Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
- Known hypersensitivity reactions to any investigational drugs;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group 1
Arm Description
Outcomes
Primary Outcome Measures
Peri-operative complications
Complications occurring in the perioperative period
Secondary Outcome Measures
Pathological response rate
Tumor Regression Grade 0-1
Pathological complete response rate
Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)
2-year local control rate
Refers to the probability of not finding local recurrence of tumor within 2 years，including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit.
2-year metastasis-free rate
Refers to the probability of no distant metastasis within 2 years
Overall survival
Refers to the time from the start of treatment to death due to any cause.
Full Information
NCT ID
NCT05111860
First Posted
October 25, 2021
Last Updated
October 28, 2021
Sponsor
Shanghai Minimally Invasive Surgery Center
1. Study Identification
Unique Protocol Identification Number
NCT05111860
Brief Title
Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy
Official Title
Efficacy and Safety of Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy for RAS Mutant-type Locally Advanced Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Minimally Invasive Surgery Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prospectively Investigate the effectiveness and safety of neoadjuvant Bevacizumab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS mutant-type locally advanced rectal cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoadjuvant Treatment, Rectal Cancer, Bevacizumab, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab+mFOLFOX6
Intervention Description
Bevacizumab 5mg/kg d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles
Primary Outcome Measure Information:
Title
Peri-operative complications
Description
Complications occurring in the perioperative period
Time Frame
From the start of treatment to 3 months after surgery
Secondary Outcome Measure Information:
Title
Pathological response rate
Description
Tumor Regression Grade 0-1
Time Frame
2 weeks after surgery
Title
Pathological complete response rate
Description
Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)
Time Frame
2 weeks after surgery
Title
2-year local control rate
Description
Refers to the probability of not finding local recurrence of tumor within 2 years，including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit.
Time Frame
2 years
Title
2-year metastasis-free rate
Description
Refers to the probability of no distant metastasis within 2 years
Time Frame
2 years
Title
Overall survival
Description
Refers to the time from the start of treatment to death due to any cause.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A biopsy proven histological diagnosis of rectal adenocarcinoma；
An ARMS-PCR proven KRAS, NRAS mutation, excluding BRAF mutation or microsatellite instablility-High;
No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
Age between 18-75 years;
ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
Has sufficient organ function:
Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L,
neutrophils ≥ 1.5 × 109/L
Liver function: ALT and AST < 2.5 × ULN;
Renal function: serum creatinine < 1.5 ULN;
Willing to participate and informed consent signed；
Exclusion Criteria:
An ARMS-PCR proven RAS wild type, BRAF mutation and microsatellite instablility-High;
Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
Female patients who are pregnant or breastfeeding;
Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
Patients with active infection;
Poor overall health status, ECOG ≥ 2;
Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
Known hypersensitivity reactions to any investigational drugs;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenghao Cai, MD
Phone
+862164458887
Email
c3z2h1@alumni.sjtu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy
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