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

NCT00671645 | Terminated Phase 2

• 1 other identifier: ABCSG R04/TAKO 08
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 10

Brief Summary

• 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)

Conditions

Rectal Cancer

Keywords

pilot study; rectal; carcinoma; phase II; preoperative; RadioChemo; molecular; target; therapy; T3; ABCSG; TAKO; R04; 08

Outcome Measures

Primary Outcomes (1)

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

  descriptive evaluation

Secondary Outcomes (1)

• collection of response rate (T- and M-downstaging, pathological complete remission)

  descriptive evaluation

Study Arms (1)

1

EXPERIMENTAL

Drug: capecitabine, bevacizumab

Interventions

capecitabine, bevacizumab DRUG

Capecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29

Also known as: Xeloda, Avastin

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Austrian Breast & Colorectal Cancer Study Group: lead
• Hoffmann-La Roche: collaborator

Study Sites (10)

Hospital BHB St. Veit/Glan, Surgery

Saint Veit/Glan, Carinthia, 9300, Austria

Location

Medical University Graz, Oncology

Graz, Styria, 8036, Austria

Location

State Hospital Leoben, Surgery

Leoben, Styria, 8700, Austria

Location

Medical University Innsbruck, Internal Medicine

Innsbruck, Tyrol, 6020, Austria

Location

Hospital BHS Linz, Radiooncology

Linz, Upper Austria, 4010, Austria

Location

Klinikum Wels-Grieskirchen, Coop. Group

Wels, Upper Austria, 4600, Austria

Location

State Hospital Feldkirch, Radiotherapy

Feldkirch, Vorarlberg, 6807, Austria

Location

State Hospital Salzburg-Paracelsius Medical University - Oncology

Salzburg, 5020, Austria

Location

Hospital BHB Vienna, Surgery

Vienna, 1020, Austria

Location

Medical University Vienna, Radiotherapy

Vienna, 1090, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Rectal Neoplasms; Carcinoma; Erythema Multiforme

Interventions

Capecitabine; Bevacizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dietmar Oefner, MD, MSc

  Austrian Breast & Colorectal Cancer Study Group

  PRINCIPAL INVESTIGATOR

• Alexander de Vries, MD

  Austrian Breast & Colorectal Cancer Study Group

  PRINCIPAL INVESTIGATOR

• Wolfgang Eisterer, MD

  ABCSG, TAKO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: July 1, 2008
• Primary Completion: February 27, 2009
• Study Completion: February 27, 2009
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

AU (10)