Xeloda and Bevacizumab to Treat Rectal Cancer
xeberecto
ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE
2 other identifiers
interventional
43
1 country
1
Brief Summary
The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedAugust 29, 2017
August 1, 2017
3.8 years
February 18, 2009
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)
Surgery date
Secondary Outcomes (8)
Overall clinical response
Surgery date
To determine the downstaging caused by treatment
Surgery date
relapse free survival
Time of radiological evidence of relapse.
Quantify the local control grade: R0 resections in surgery
Surgery date
Local relapse and distant relapse rates
Relapse date
- +3 more secondary outcomes
Study Arms (1)
Bevacizumab & capecitabine & radiotheraphy
EXPERIMENTALBevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.
Interventions
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.
Eligibility Criteria
You may qualify if:
- The patient has given written informed consent prior to any study related procedure
- Male and female aged 18 to 75 years
- ECOG performance status 0 or 1
- Histologically confirmed diagnostic of adenocarcinoma of the rectum \< 15 cm from anal verge
- Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
- Disease evaluable by imaging techniques
- No tumour haemorrhage in the week prior to start of study treatment
- External derivation in symptomatic occlusive tumours
- Not prior cancer treatment
- Adequate bone marrow, hepatic and renal function, defined as:
- White blood cells ≥ 4 x 109 /l
- Absolute neutrophil count ≥ 1.5 x 109 /l
- Platelets ≥ 100 x 109 /l
- Haemoglobin ≥10 g/dl
- Bilirubin \< 1.25 x upper limit of normal
- +3 more criteria
You may not qualify if:
- Rectal cancer no amenable to resection
- Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
- Pregnant or breast-feeding women
- Women oh childbearing potential unless effective methods of contraception are used
- No prior or concurrent significant medical conditions, including any of the following:
- Cerebrovascular disease (including transient ischemic attack and stroke) within the past year
- Cardiovascular disease, including the following:
- Myocardial infarction within the past year
- Uncontrolled hypertension while receiving chronic medication
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Major trauma within the past 28 days
- Serious nonhealing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Català d'Oncologialead
- Hoffmann-La Rochecollaborator
Study Sites (1)
Institut Català d'Oncologia-L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona, 08907, Spain
Related Publications (1)
Garcia M, Martinez-Villacampa M, Santos C, Navarro V, Teule A, Losa F, Pisa A, Cambray M, Soler G, Lema L, Kreisler E, Figueras A, Juan XS, Vinals F, Biondo S, Salazar R. Phase II study of preoperative bevacizumab, capecitabine and radiotherapy for resectable locally-advanced rectal cancer. BMC Cancer. 2015 Feb 26;15:59. doi: 10.1186/s12885-015-1052-0.
PMID: 25886275RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramon Salazar, Phd
Institut Català d'Oncologia
- STUDY CHAIR
Margarita Garcia, MD
Institut Català d'Oncologia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
September 1, 2007
Primary Completion
June 1, 2011
Study Completion
February 1, 2015
Last Updated
August 29, 2017
Record last verified: 2017-08