Rectal Cancer
Conditions
Keywords
Rectal Cancer, Bevacizumab, capecitabine, oxaliplatin, preoporative IMRT
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.
Interventions
DRUGXeloda
po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles
DRUGOxaliplatin
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
DRUGBevacizumab
iv, 7.5 mg/kg, day 1, 3 cycles during neoadjuvant chemotherapy and concurrent chemoradiotherapy
RADIATIONRadiation
Intensity-modulated radiation therapy, 50 Gy/25 fractions during 5 weeks
PROCEDUREsurgery
Total Mesorectal Excision (TME)
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pathologic tumor regression grade (TRG) | March 30, 2015 |
Secondary
| Measure | Time frame |
|---|---|
| 5-y overall survival | March 30, 2020 |
| Occurence of toxicity | March 30, 2015 |
| 5-y local relapse free survival | March 30, 2020 |
Countries
China
Contacts
Primary ContactYuanhong Gao
Outcome results
None listed