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Phase 2
18 Years
70 Years
Open (Enrolling)
Rectal Cancer

Thank you

Trial Information

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The pathologic tumor regression grade (TRG)

Outcome Time Frame:

March 30, 2015

Safety Issue:



China:Institutional Review Board of Sun Yat-sen University Cancer Center

Study ID:




Start Date:

March 2013

Completion Date:

March 2020

Related Keywords:

  • Rectal Cancer
  • Rectal Cancer
  • Bevacizumab
  • capecitabine
  • oxaliplatin
  • preoporative IMRT
  • Rectal Neoplasms