Back to resultsA Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FOLFIRI+beacizumab
CRT
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring neoadjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 1. Clinical stage II or stage III rectal cancer patients diagnosed by preoperative biopsy pathology report, endoscopic examination report and preoperative abdominal pelvic dynamic contrast enhanced-MRI examination (DCE-MRI); 2. Primary tumor lesions within 4~12 cm from the anus through endoscopic examination; 3. No distant metastasis and intestinal obstruction; 4. No surgical contraindications; 5. Can be treated with neoadjuvant chemotherapy confirmed by normal routine examination; 6. informed consent with patients and family members before treatment.
Exclusion Criteria:
- history of beacizumab allergy, being treated with other therapy important viscera dysfunction and severe heart disease, including congestive heart failure, arrhythmia beyond the control, long-term drug treatment of angina pectoris, heart valve disease, myocardial infarction, and resistant hypertension; infectious wound and uncontrollable history of mental illness; infectious sexual diseases.
Sites / Locations
- First Affiliated Hospital, Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
beacizumab+ neoadjuvant chemotherapy (FOLFIRI+beacizumab)
neoadjuvant CRT for consecutive 5 weeks
Outcomes
Primary Outcome Measures
R0 resection rate
percent
Secondary Outcome Measures
disease-free survival (DFS)
year
overall survival (OS)
year
overall response rate (ORR)
percent
Full Information
NCT ID
NCT03245203
First Posted
August 1, 2017
Last Updated
August 7, 2017
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03245203
Brief Title
A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer
Official Title
A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to reduce the local recurrence rate, however, no improvement of distant metastasis rate was observed, and the incidence of postoperative local recurrence and distant metastasis can reach more than 25%. It is still a challenge for us to improve the RO resection rate of locally advanced rectal cancer and reduce the incidence of local recurrence and distant metastasis.
Detailed Description
Objective: compared with the postoperative adjuvant therapy, neoadjuvant chemotherapy has shown better compliance of LARC patients, and may be more effective in reducing the incidence of local recurrence and distant metastasis. This study used the anti-angiogenesis drugs beacizumab and chemotherapy in patients with LARC for neoadjuvant chemotherapy, and investigated the short-term efficacy to provide objective basis for the selection of neoadjuvant therapy.
Methods: 70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
beacizumab+ neoadjuvant chemotherapy (FOLFIRI+beacizumab)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
neoadjuvant CRT for consecutive 5 weeks
Intervention Type
Procedure
Intervention Name(s)
FOLFIRI+beacizumab
Intervention Description
Eligible patients received bevacizumab 5.0 mg/kg followed by irinotecan 125mg/m2 combined with LV 200mg/m2 followed by 5-FU bolus 400mg/m2,then 5-FU infusion 2.4~3.0g/m2 over a 46-h period.Those agents were given for a 2-week cycle.Treatment was administered for six cycles. LARC was reevaluated and operated after 4~8 weeks.
Intervention Type
Procedure
Intervention Name(s)
CRT
Intervention Description
total dose of radiotherapy was 40~50Gy, a subdose of 1.8~2Gy for continuous 5 weeks, 5 times/week.Then,5-FU infusion 400mg/m2 combined with LV 200mg/m2 over 24 h for 4 days/week during the first and fifth weeks of radiotherapy.Whereas,Capecitabine was administered orally at a dose of 825mg/m2 twice a day for 5 days of a week. Second staging and operation were performed in the sixth week after chemoradiotherapy.
Primary Outcome Measure Information:
Title
R0 resection rate
Description
percent
Time Frame
3 years
Secondary Outcome Measure Information:
Title
disease-free survival (DFS)
Description
year
Time Frame
3 years
Title
overall survival (OS)
Description
year
Time Frame
3 years
Title
overall response rate (ORR)
Description
percent
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Clinical stage II or stage III rectal cancer patients diagnosed by preoperative biopsy pathology report, endoscopic examination report and preoperative abdominal pelvic dynamic contrast enhanced-MRI examination (DCE-MRI); 2. Primary tumor lesions within 4~12 cm from the anus through endoscopic examination; 3. No distant metastasis and intestinal obstruction; 4. No surgical contraindications; 5. Can be treated with neoadjuvant chemotherapy confirmed by normal routine examination; 6. informed consent with patients and family members before treatment.
Exclusion Criteria:
history of beacizumab allergy, being treated with other therapy important viscera dysfunction and severe heart disease, including congestive heart failure, arrhythmia beyond the control, long-term drug treatment of angina pectoris, heart valve disease, myocardial infarction, and resistant hypertension; infectious wound and uncontrollable history of mental illness; infectious sexual diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nan du
Phone
13911599657
Email
dunan304@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nan du
Organizational Affiliation
First Affiliated Hospital, Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital, Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer
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