Preoperative Combined RadioChemo-Molecular Target Therapy With Capecitabine, Bevacizumab, and Radiotherapy

October 13, 2020 updated by: Austrian Breast & Colorectal Cancer Study Group

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)

  • feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
  • collection of response rate (T- and M-downstaging, pathological complete remission)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 bevacizumab

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • State Hospital Salzburg-Paracelsius Medical University - Oncology
      • Vienna, Austria, 1020
        • Hospital BHB Vienna, Surgery
      • Vienna, Austria, 1090
        • Medical University Vienna, Radiotherapy
    • Carinthia
      • St. Veit/Glan, Carinthia, Austria, 9300
        • Hospital BHB St. Veit/Glan, Surgery
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University Graz, Oncology
      • Leoben, Styria, Austria, 8700
        • State Hospital Leoben, Surgery
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University Innsbruck, Internal Medicine
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Hospital BHS Linz, Radiooncology
      • Wels, Upper Austria, Austria, 4600
        • Klinikum Wels-Grieskirchen, Coop. Group
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6807
        • State Hospital Feldkirch, Radiotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Capecitabine
  • 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 investigator
  • 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 recruitment
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: capecitabine, bevacizumab
Capecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29
Other Names:
  • Avastin
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
Time Frame: descriptive evaluation
descriptive evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
collection of response rate (T- and M-downstaging, pathological complete remission)
Time Frame: descriptive evaluation
descriptive evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Dietmar Oefner, MD, MSc, Austrian Breast & Colorectal Cancer Study Group
  • Principal Investigator: Wolfgang Eisterer, MD, ABCSG, TAKO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

February 27, 2009

Study Completion (ACTUAL)

February 27, 2009

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

April 30, 2008

First Posted (ESTIMATE)

May 5, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABCSG R04/TAKO 08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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