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.