Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
516 participants
INTERVENTIONAL
2010-12-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cap+Bev until PD followed by CAPIRI +Bev
Capecitabine + Bevacizumab
In case of Progression Escalation to:
Capecitabine + Irinotecan + Bevacizumab
Capecitabine
Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21
Bevacizumab
Bevacizumab: 7.5 mg/kg day 1 q day 21
Capiri + Bev
Capecitabine + Irinotecan + Bevacizumab
Capecitabine
Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21
Irinotecan
Irinotecan: 200 mg/m2 day 1 , q day 21
Bevacizumab
Bevacizumab: 7.5 mg/kg day 1, q day 21
Interventions
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Capecitabine
Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21
Bevacizumab
Bevacizumab: 7.5 mg/kg day 1 q day 21
Capecitabine
Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21
Irinotecan
Irinotecan: 200 mg/m2 day 1 , q day 21
Bevacizumab
Bevacizumab: 7.5 mg/kg day 1, q day 21
Eligibility Criteria
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Inclusion Criteria
* Stage IV disease.
* ECOG 0-1.
* Patients considered suitable for application of chemotherapy.
* Age 18 - 75 years.
* In- or outpatient treatment.
* Estimated life expectancy \> 3 months.
* Measurable index lesion according to RECIST criteria. Evaluation of tumor manifestations ≤ 2 weeks prior to treatment start.
* Effective contraception.
* Adequate hematologic function: leukocytes \>= 3000/µl, neutrophils \>= 1500/µl, platelets \>= 100.000/µ, and hemoglobin \>= 9g/dl. Bilirubin \<= 1,5x upper limit of normal (ULN). ALAT and ASAT \<= 2,5x ULN, in case of liver metastases \<= 5x ULN. Serum creatinine \<= 1,5x ULN.
* No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1 week prior to treatment start. Operation sequels need to be completely healed. Major operations must not be expected at time of study begin, except for potential secondary resection of liver metastases. In case of secondary resection of liver metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.
* No relevant toxicities due to prior medical treatment at time of study entry.
Exclusion Criteria
* heart failure Grade III/IV (NYHA-classification)
* Prior treatment directed against the epidermal growth factor receptor (EGFR).
* Prior treatment with bevacizumab.
* Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating back \> 6 months prior to study entry.
* Experimental medical treatment within 30 days prior to study entry.
* Known hypersensitivity reaction to any study medication.
* Pregnant or breast feeding women (pregnancy needs to be excluded by testing of beta-HCG).
* Known or suspected cerebral metastases.
* Clinically significant coronary heart disease, myocardial infarction within the last 12 months or high risk of uncontrolled arrhythmia.
* Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.
* Abdominal or tracheo-esophageal fistulas, gastrointestinal perforation within 6 months before study entry
* Symptomatic peritoneal carcinosis.
* Severe chronic wounds, ulcera or bone fracture.
* Uncontrolled hypertension.
* Severe proteinuria (nephrotic syndrome).
* Arterial thromboembolic events or hemorrhage within 6 months prior to study entry (except tumor bleeding surgically treated by tumor resection).
* Bleeding diatheses or coagulopathy.
* Full dose anticoagulation.
* Known DPD-deficiency (special screening not required).
* Known glucuronidation-deficiency (special screening not required).
* Contraindication with irinotecan
* Medical history of other malignant disease within 5 years prior to study entry, except for basalioma, and in-situ cervical carcinoma if treated with curative intent.
* Known alcohol or drug abuse.
* Medical or psychiatric condition which contradicts participation of study.
* Limited legal capacity.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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University of Munich - Klinikum der Universitaet Muenchen
Principal Investigators
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Volker Heinemann, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University of Munich - Klinikum der Universitaet Muenchen
Sebastian Stintzing, Dr. med.
Role: STUDY_CHAIR
University of Munich - Klinikum der Universitaet Muenchen
Clemens Giessen
Role: STUDY_CHAIR
University of Munich - Klinikum der Universitaet Muenchen
Locations
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University of Munich - Klinikum der Universitaet Muenchen
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Stahler A, Modest DP, Fischer von Weikersthal L, Kaiser F, Decker T, Held S, Graeven U, Schwaner I, Denzlinger C, Schenk M, Kurreck A, Heinrich K, Giessen-Jung C, Neumann J, Kirchner T, Jung A, Stintzing S, Heinemann V. First-line fluoropyrimidine plus bevacizumab followed by irinotecan-escalation versus initial fluoropyrimidine, irinotecan and bevacizumab in patients with metastatic colorectal cancer - Final survival and per-protocol analysis of the randomised XELAVIRI trial (AIO KRK 0110). Eur J Cancer. 2022 Sep;173:194-203. doi: 10.1016/j.ejca.2022.06.019. Epub 2022 Aug 5.
Stahler A, Heinemann V, Schuster V, Heinrich K, Kurreck A, Giessen-Jung C, Fischer von Weikersthal L, Kaiser F, Decker T, Held S, Graeven U, Schwaner I, Denzlinger C, Schenk M, Neumann J, Kirchner T, Jung A, Kumbrink J, Stintzing S, Modest DP. Consensus molecular subtypes in metastatic colorectal cancer treated with sequential versus combined fluoropyrimidine, bevacizumab and irinotecan (XELAVIRI trial). Eur J Cancer. 2021 Nov;157:71-80. doi: 10.1016/j.ejca.2021.08.017. Epub 2021 Sep 8.
Heinrich K, Modest DP, Ricard I, Fischer von Weikersthal L, Decker T, Kaiser F, Graeven U, Uhlig J, Schenk M, Freiberg-Richter J, Peuser B, Denzlinger C, Giessen-Jung C, Stahler A, Michl M, Held S, Jung A, Kirchner T, Stintzing S, Heinemann V. Gender-dependent survival benefit from first-line irinotecan in metastatic colorectal cancer. Subgroup analysis of a phase III trial (XELAVIRI-study, AIO-KRK-0110). Eur J Cancer. 2021 Apr;147:128-139. doi: 10.1016/j.ejca.2021.01.025. Epub 2021 Feb 27.
Modest DP, Fischer von Weikersthal L, Decker T, Vehling-Kaiser U, Uhlig J, Schenk M, Freiberg-Richter J, Peuser B, Denzlinger C, Peveling Genannt Reddemann C, Graeven U, Schuch G, Schwaner I, Stahler A, Jung A, Kirchner T, Held S, Stintzing S, Giessen-Jung C, Heinemann V; XELAVIRI/AIO KRK0110 Investigators. Sequential Versus Combination Therapy of Metastatic Colorectal Cancer Using Fluoropyrimidines, Irinotecan, and Bevacizumab: A Randomized, Controlled Study-XELAVIRI (AIO KRK0110). J Clin Oncol. 2019 Jan 1;37(1):22-32. doi: 10.1200/JCO.18.00052. Epub 2018 Nov 2.
Giessen C, von Weikersthal LF, Hinke A, Stintzing S, Kullmann F, Vehling-Kaiser U, Mayerle J, Bangerter M, Denzlinger C, Sieber M, Teschendorf C, Freiberg-Richter J, Schulz C, Modest DP, Moosmann N, Aubele P, Heinemann V. A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: the AIO KRK 0110 trial/ML22011 trial. BMC Cancer. 2011 Aug 23;11:367. doi: 10.1186/1471-2407-11-367.
Other Identifiers
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ML22011
Identifier Type: -
Identifier Source: org_study_id
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