Clinical trial NCT01818973: Preoporative Bevacizumab, Radiation Therapy, and XELOX Chemotherapy for Locally Advanced Nonmetastatic Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Bevacizumab
capecitabine
oxaliplatin
preoporative IMRT
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Giving bevacizumab together with radiation therapy and combination chemotherapy before surgery may achieve promising improvements in pCR rates, we designed this Phase II study in patients with T3/4 or N1/2 loco-regionally advanced rectum cancer, to examine the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The pathologic tumor regression grade (TRG)
timeFrame: March 30, 2015
Secondary outcomes:
measure: 5-y overall survival
timeFrame: March 30, 2020
measure: Occurence of toxicity
timeFrame: March 30, 2015
measure: 5-y local relapse free survival
timeFrame: March 30, 2020
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center (SYSUCC)
state: Guangdong
Study officials:
References:
citation: 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.