Overview

Preoporative Bevacizumab, Radiation Therapy, and XELOX Chemotherapy for Locally Advanced Nonmetastatic Rectal Cancer

Status:
Unknown status
Trial end date:
2020-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Bevacizumab
Capecitabine
Oxaliplatin
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.