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Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx)

Phase 2
18 Years
80 Years
Not Enrolling
Rectal Cancer

Thank you

Trial Information

Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx)

Combined RadioChemotherapy:

Therapy start: within 28 days after bioptical diagnosis

Radiotherapy: 5 x 5 days 1.8 Gy radiotherapy; cummulative dose 45 Gy

Chemotherapy: Capecitabin 825mg/m² bid, on each radiation day during the first 4 weeks RCTx

Molecular Targeted Therapy: Bevacizumab 5 mg/kg body weight; day 1, 15, 29 Operation due to
TME adherence to a break of min. 42 to max. 56 days after the last application of

Inclusion Criteria:

- age: 18 - 80

- bioptical confirmed adenocarcinoma of the rectum in T3NxM0 status. The tumor has to
be basically surgically complete resectable (->R0).

- no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of
rectum carcinoma

- WHO performance status 0-2

- adequate bone marrow reserve (granulocytes >= 3.000/µl, absolute neutrophil >= 0 1,5
x 10 9/l thrombocytes: >= 100.000/µl, haemoglobin >= 10g/dl)

- adequate hepatic function (Bilirubin: <= 1.5 x ULN, GOT und GPT <= 2.5 x ULN)

- adequate renal function (creatinin: <= 1.25 mg/dl, creatinin-clearance: > 50 ml/min
(Cockcroft and Gault formula)), proteinuria: dipstick < 2+. In case of dipstick > 2+
protein has to be measured in 24h urine and does not exceed more than 1g/24h)

- ability of intake of pills

- women of childbearing potential: exclusion of pregnancy (negative urin or serum
pregnancy test)

- willingness of women of childbearing potential and accordingly of potent men to use
approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3
month after conclusion of the study

- life expectancy of at least 3 month

- INR and aPTT < 1.5 ULN

- signed Informed Consent before recruitment

Exclusion Criteria:

- failure of one inclusion criteria

- former radiotherapy of pelvis or abdomen

- former chemotherapy

- any other kind of malign tumor in the last 5 years

- any other kind of tumour in the last 5 years with exception of basal cell carcinoma
of skin and cervix carcinoma in situ

- general contraindication or known hypersensitivity against Bevacizumab and/or

- non malign disease, if there is a contraindication with radiotherapy, or chemotherapy
with Bevacizumab and Capecitabine, or a resection of rectum: uncontrolled
hypertension (systolic > 150 mmHG and/or diastolic >100 mmHG) or clinical significant
(e.g. active) cardiovascular disease: CVA (cardiovascular accident)/ cerebral
apoplexy (< 6 months before recruitment), myocardial infarct (< 6 months before
recruitment), instable angina pectoris, CHF with NYHA status II or higher, or treated
serious arrhythmia, hepatic disease, significant neurologic or psychiatric disorders

- florid, serious infections at the time of recruitment

- peripheral neuropathy (NCI CTC >= Grade 1)

- legally limited contractual capability or evidence of neurological or psychiatric
disease, if it will constrict the patients compliance in the opinion of the

- evidence of lacking cooperation of the patient

- major intervention within 28 days before recruitment, open wounds

- serious injuries, unhealed wounds or fractures

- patients with spinal compressions or metastases in central nervous system

- evidence of bleeding diathesis or coagulation dysfunction

- actual intake of anticoagulant or thrombolytic agents, Aspirin > 325 mg/d or within
10 days before study start)

- actual or recent (within 10 days before recruitment) therapeutic therapy with
fully-dosed anticoagulants. A prophylactic treatment is permitted.

- previous thromboembolic or hemorrhagic events within the last 6 months before

- previous abdominal fistulas, GI perforation or intra-abdominal abscess within the
last 6 months

- treatment with other study medication within 28 days before recruitment

- patients with malabsorption syndrome or difficulties swallowing

- pregnant or breast feeding women

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma

Outcome Time Frame:

descriptive evaluation

Safety Issue:


Principal Investigator

Dietmar Oefner, MD, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Austrian Breast & Colorectal Cancer Study Group


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

July 2008

Completion Date:

March 2010

Related Keywords:

  • Rectal Cancer
  • pilot study
  • rectal
  • carcinoma
  • phase II
  • preoperative
  • RadioChemo
  • molecular
  • target
  • therapy
  • T3
  • TAKO
  • R04
  • 08
  • Rectal Neoplasms