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

Rectal Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00671645
• Other study ID #: ABCSG R04/TAKO 08
• Status: Terminated
• Phase: Phase 2
• Start date: July 2008
• Est. completion date: February 27, 2009

Study information

• Verified date: October 2020
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 27, 2009
• Est. primary completion date: February 27, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Austria	State Hospital Feldkirch, Radiotherapy	Feldkirch	Vorarlberg
Austria	Medical University Graz, Oncology	Graz	Styria
Austria	Medical University Innsbruck, Internal Medicine	Innsbruck	Tyrol
Austria	State Hospital Leoben, Surgery	Leoben	Styria
Austria	Hospital BHS Linz, Radiooncology	Linz	Upper Austria
Austria	State Hospital Salzburg-Paracelsius Medical University - Oncology	Salzburg
Austria	Hospital BHB St. Veit/Glan, Surgery	St. Veit/Glan	Carinthia
Austria	Hospital BHB Vienna, Surgery	Vienna
Austria	Medical University Vienna, Radiotherapy	Vienna
Austria	Klinikum Wels-Grieskirchen, Coop. Group	Wels	Upper Austria

Sponsors (2)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group	Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	collection of response rate (T- and M-downstaging, pathological complete remission)		descriptive evaluation

External Links

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