Preoperative Radiotherapy With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer: CRAB Phase II Study
18 Years
80 Years
Both
Locally Advanced Rectal Cancer
Trial Information
Preoperative Radiotherapy With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer: CRAB Phase II Study
- radiotherapy: 45 Gy to the pelvis (25x 1.8 Gy on days 1-33, excluding weekends) plus
5.4 Gy on days 36-38 as a boost to the primary tumour (3 fractions of 1.8 Gy).Three-
dimensional CT planing and a four field box technique with high energy photons (15 MV)
will be used. All fields will be treated daily. Multileaf collimators will be used to
shape individual radiation fields. Patients will be irradiated in a prone position with
a full bladder and by using belly board to minimize exposure of the small bowel.
- capecitabine 825 mg/m² p.o. twice daily on days 1-38 (including weekends),
- bevacizumab: at dose 5 mg/kg on days -14, 2, 16,30.
- Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of
chemoradiation.
Postoperative treatment (in patients achieving histopathological R0 or R1
resection):capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days every three
weeks; 4 cycles (R0)or 6 cycles (R1) beginning 6-8 weeks after surgery
Inclusion Criteria:
- Male or female patients with histologically proven adenocarcinoma of the rectum
(tumour located below the peritoneum), T3/4 or any node positive disease (clinical
stage according the TNM classification system)
- No evidence of metastatic disease.
- The disease must be considered either resectable at the time of entry or thought to
become resectable after preoperative chemoradiation.
- Age 18 - 80 years
- WHO Performance Status 0-2
- No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
- Adequate hematological, hepatic and renal function Ability to swallow tablets
- Signed informed consent
- Patients must be willing and able to comply with the protocol for duration of the
study
Exclusion Criteria:
- Malignancy of the rectum other than adenocarcinoma
- Any unrested synchronous colon cancer
- Other co-existing malignancy or malignancy within the past 5 years, with the
exception of adequately treated in situ carcinoma of the cervix or basal cell
carcinoma of the skin
- Significant heart disease (uncontrolled hypertension despite of medication (> 150/100
mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction
within the past 1 year prior the study entry, history of significant ventricular
arrhythmia requiring treatment)
- Serious, non-healing wound, ulcer or bone fracture
- Evidence of active peptic ulcer or upper GI bleeding
- Evidence of bleeding diathesis or coagulopathy
- Chronic daily treatment with high-dose aspirin(>325mg/day)
- Current or recent (>10 days) use of full-dose of parenteral anticoagulants or
thrombolytic agents for therapeutic purpose
- Patients receiving a concomitant treatment with drugs interacting with capecitabine
such as flucitosine, phenytoin, or warfarin
- Known dihydropyrimidine dehydrogenase (DPD)deficiency
- Major surgery within 4 weeks prior to study treatment starts, or lack of complete
recovery from the effects of major surgery or open biopsy
- Known hypersensitivity to biological drugs
- Treatment with any investigational drug within 30 days before beginning treatment
with the study drug
- Pregnant or lactating patient
- Females with a positive or no pregnancy test unless childbearing potential can be
otherwise excluded (amenorrheic for at least 2 years,hysterectomy or oophorectomy)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological complete remission rate (pCR)
Outcome Time Frame:
after pathological examination of surgical speciments
Safety Issue:
No
Principal Investigator
Vaneja Velenik, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Institute of Oncology, Ljubljana, Slovenia
Authority:
Slovenia: Agency for Medicinal Products - Ministry of Health
Study ID:
ML21901
NCT ID:
NCT00842686
Start Date:
January 2009
Completion Date:
August 2014
Related Keywords:
- Locally Advanced Rectal Cancer
- rectal cancer
- capecitabine
- bevacizumab
- radiotherapy
- Rectal Neoplasms
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