Preoporative Bevacizumab, Radiation Therapy, and XELOX Chemotherapy for Locally Advanced Nonmetastatic Rectal Cancer
1 other identifier
interventional
45
1 country
1
Brief Summary
We presumed that the addition of a monoclonal antibody Bevacizumab into radiation therapy and combination chemotherapy could results in improved pathologic tumor regression grade (TRG) in locally advanced nonmetastatic rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 23, 2013
CompletedFirst Posted
Study publicly available on registry
March 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedJune 8, 2015
June 1, 2015
2.3 years
March 23, 2013
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The pathologic tumor regression grade (TRG)
March 30, 2015
Secondary Outcomes (3)
5-y overall survival
March 30, 2020
Occurence of toxicity
March 30, 2015
5-y local relapse free survival
March 30, 2020
Study Arms (1)
Single Arm
EXPERIMENTALNeoadjuvant chemotherapy with XELOX: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 130mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1, during the first cycle (each cycle has 3 weeks). Followed by chemoradiotherapy, 50 Gy/25 fractions during 5 weeks plus 2 cycles XELOX and Bevacizumab: Xeloda, po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning; Oxaliplatin, iv, 100mg/m2, day 1; and Bevacizumab, iv, 7.5 mg/kg, day 1. 6-7 weeks from the last radiation therapy, Total Mesorectal Excision (TME) surgery will be performed. 3-4 weeks after operation, 3 cycles XELOX (the same as the neoadjuvant chemotherapy) and 2 cycles Xeloda (po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning) will be administered.
Interventions
po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles
iv, 130mg/m2, day 1, 1 cycle during neoadjuvant chemotherapy and 3 cycles in adjuvant chemotherapy 100mg/m2, day 1, 2 cycles during concurrent chemoradiotherapy
iv, 7.5 mg/kg, day 1, 3 cycles during neoadjuvant chemotherapy and concurrent chemoradiotherapy
Intensity-modulated radiation therapy, 50 Gy/25 fractions during 5 weeks
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the colon or rectum.
- T3 or T4 adenocarcinoma or node positive colorectal tumours.
- Appropriate staging investigations of the primary tumour, either endorectal ultrasound or pelvic MRI.
- Male or female aged 18 to 70.
- Have a performance status ECOG of 0 or 1.
- Have a life expectancy greater than 6 months.
- Adequate organ function and coagulation parameters as measured by: WBC \> 4000/mm3, PLT \> 100000/mm3, Hb \> 10g/dL, ALT \< 1.5X ULN, AST \< 1.5X ULN, bilirubin \< 1.5mg/dL Serum creatinine \< 1.8mg/dL.
- Patient consent.
You may not qualify if:
- Known to have clinical or radiological evidence of distant metastases.
- Evidence of intestinal obstruction (except for those after enterostomy).
- Patients with a past history of colorectal surgery (except for enterostomy), chemtherapy, radiation, biotherapy or targeted therapy.
- Pregnant woman OR women of childbearing potential with a positive pregnancy test at baseline or lactating.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Patients with a past or current history (within last 5 years) of other malignancies, except for the indication under this study and curatively treated basal and squamous skin cancer or in-situ cancer of the cervix.
- Patients with mental disorder unable to complete the informed consent.
- Uncontrolled hypertension.
- Clinically significant (i.e. active) cardiovascular disease for example:
- cerebrovascular accidents (\<=6 months), myocardial infarction (\<= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
- Moderate or serious proteinuria.
- Known hypersensitivity against experimental drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, 510060, China
Related Publications (1)
Yu X, Wang QX, Xiao WW, Chang H, Zeng ZF, Lu ZH, Wu XJ, Chen G, Pan ZZ, Wan DS, Ding PR, Gao YH. Neoadjuvant oxaliplatin and capecitabine combined with bevacizumab plus radiotherapy for locally advanced rectal cancer: results of a single-institute phase II study. Cancer Commun (Lond). 2018 May 21;38(1):24. doi: 10.1186/s40880-018-0294-z.
PMID: 29784042DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professo
Study Record Dates
First Submitted
March 23, 2013
First Posted
March 27, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2015
Study Completion
March 1, 2020
Last Updated
June 8, 2015
Record last verified: 2015-06