Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy

NCT01434147 | Completed Phase 2 DMC

• 2 other identifiers: ABCSG R052010-024354-11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma

Conditions

Rectal Cancer

Keywords

locally advanced rectal cancer; preoperative induction chemotherapy chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• termination of therapy

  before surgery (after conclusion of therapy phase)

  up to 17 weeks

• occurence of toxicity

  until timepoint of discharge of patient

  up to 18-19 weeks

Secondary Outcomes (2)

• collection of response rate

  up to week 18

• post-surgery morbidity

  after 18-19 weeks

Study Arms (1)

induction chemotherapy + radiochemotherapy

EXPERIMENTAL

preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine induction chemotherapy: starts within 28 days after bioptical diagnosis. All patients are administered with capecitabine (Xeloda®) 1000 mg/m2 bid during 14 days (d1-d14), oxaliplatin 130 mg/m2 and bevacizumab (Avastin®) 7.5 mg/kg body weight on day 1; repetition days 22 and 43 (3 cycles) Combined radiochemotherapy: starts at the earliest one week after concluded third cycle of induction chemotherapy. Radiotherapy takes place on 5 x 5 days (dose: 1.8 Gy; cumulative dose: 45 Gy). For chemotherapy patients are administered with capecitabine (Xeloda®) 825mg/m² bid, on each radiation day during the first 4 weeks of radiochemotherapy.

Drug: preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine

Interventions

preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine DRUG

Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)

Also known as: Xeloda (capecitabine), Avastin (bevacizumab), Oxaliplatin

induction chemotherapy + radiochemotherapy

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 years
• Histologic confirmation of rectal adenocarcinoma stage cT3 (≤ 5mm to the mesorectal fascia)/cT4( primary curative intention)NxM0
• No former chemotherapy, no former radiotherapy of the pelvic, no former tumour resection of a rectal carcinoma
• General condition WHO grade 0-2
• Adequate bone marrow reserve ( leucocytes ≥3 000/μl, thrombocytes ≥100 000/μl)
• Adequate renal function (creatinine ≤ 1,5 mg/dl, creatinine clearance \> 50ml/min (Cockcroft and Gault formula))
• Adequate liver function (bilirubin ≤1,5x ULN, GOT and GPT ≤3,5xULN)
• Female patients with childbearing potential and male patients that are not surgically sterile must be practicing a medically acceptable contraceptive regimen while on study treatment until 3 months after the end of the study (e.g. oral contraceptives, condom, intrauterine device)
• Life expectancy of at least 3 months
• INR and aPTT ≤ 1,5 x LLN
• Provision of signed informed consents before registration

You may not qualify if:

• Rectal carcinoma stage cT3 (\> 5mm from the mesorectal fascia) all stages \<cT3, M1
• Other malignant tumours within the last 5 years except cervical carcinoma in situ and basal cell carcinoma of the skin
• General contraindication or known hypersensitivity against Bevacizumab, Capecitabine and Oxaliplatin
• Not malignant diseases for which treatment with radiotherapy, resection of the rectum and treatment with chemotherapy (Bevacizumab, Capecitabine) is contraindicated: uncontrolled hypertension (systolic \> 150 mmHG and/or diastolic \> 100 mmHG) or clinically significant (e.g. active) cardiovascular diseases: CVA (cardiovascular accident)/ apoplectic insult (≤ 6 months prior to registration), myocardial infarction (≤ 6 months prior to registration), unstable angina pectoris, CHF(congestive heart failure) with NYHA (New York heart Association) Grade II or higher, cardiac arrhythmia requiring therapy, hepatic diseases, significant neurologic or psychiatric disorders
• Florid, serious infection at registration
• Peripheral neuropathy (NCI CTCAE v 4.0 ≥ grade 1)
• Juridically limited contractual capability, indication of neurological or psychiatric disease which constrains upon investigators opinion the patients capability to adhere to the study routines
• Major surgical procedure within 28 days prior start of the study, open wounds
• Significant traumatic injury, bone fracture, unhealed wounds
• Patients with spinal cord compression or metastases in the central nervous system
• Indication of bleeding diathesis or coagulopathy
• Intake of anticoagulant or thrombolytic agents and/or Aspirin \> 325 mg/d within 10 days prior to registration
• Current or recent (within 10 days prior to treatment start) therapy with full dosed anticoagulants. Preventive therapy is allowed.
• Previous thromboembolic or haemorrhagic events within 6 months prior to registration
• Previous abdominal fistulas, gastro-intestinal perforation or intrabdominal abscesses within 6 months prior to registration

Sponsors & Collaborators

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

Study Sites (7)

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, 9330, Austria

Location

Paracelsus Medical University Salzburg - Oncology

Salzburg, Salzburg, 5020, Austria

Location

Medical University Graz, Oncology

Graz, Styria, 8036, Austria

Location

Medical University Innsbruck, Internal Medicine

Innsbruck, Tyrol, 6020, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Medical University of Vienna, General Hospital

Vienna, Vienna, 1090, Austria

Location

State Hospital Feldkirch, Radiotherapy

Feldkirch, Vorarlberg, 6807, Austria

Location

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Related Links

• open studies

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Bevacizumab; Oxaliplatin

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

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; Coordination Complexes; Organic Chemicals

Study Officials

• Dietmar Öfner, MD, Head

  Austrian Breast & Colorectal Cancer Study Group

  STUDY CHAIR

• Alexander de Vries, MD, Head

  Austrian Breast & Colorectal Cancer Study Group

  STUDY CHAIR

• Wolfgang Eisterer, MD

  Austrian Breast & Colorectal Cancer Study Group

  STUDY CHAIR

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: September 13, 2011
• First Posted: September 14, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

AU (7)