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Xeloda and Bevacizumab to Treat Rectal Cancer (xeberecto)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00847119
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : August 29, 2017
Hoffmann-La Roche
Information provided by (Responsible Party):
Institut Català d'Oncologia

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Biological: Bevacizumab Drug: capecitabine (Xeloda) Radiation: Rectal Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Bevacizumab & capecitabine & radiotheraphy

Bevacizumab 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.

Biological: Bevacizumab
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.

Drug: capecitabine (Xeloda)
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period

Radiation: Rectal Radiotherapy
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Primary Outcome Measures :
  1. Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece) [ Time Frame: Surgery date ]

Secondary Outcome Measures :
  1. Overall clinical response [ Time Frame: Surgery date ]
  2. To determine the downstaging caused by treatment [ Time Frame: Surgery date ]
  3. relapse free survival [ Time Frame: Time of radiological evidence of relapse. ]
  4. Quantify the local control grade: R0 resections in surgery [ Time Frame: Surgery date ]
  5. Local relapse and distant relapse rates [ Time Frame: Relapse date ]
  6. To determine the security profile of this neoadjuvant treatment (radio- chemotherapy) [ Time Frame: From date of register to surgery date ]
  7. Surgery complication rate [ Time Frame: During surgery admission. ]
  8. To determine the angiogenic profile changes in tumour. [ Time Frame: 15 days, 6 weeks and 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient has given written informed consent prior to any study related procedure
  2. Male and female aged 18 to 75 years
  3. ECOG performance status 0 or 1
  4. Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge
  5. Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
  6. Disease evaluable by imaging techniques
  7. No tumour haemorrhage in the week prior to start of study treatment
  8. External derivation in symptomatic occlusive tumours
  9. Not prior cancer treatment
  10. Adequate bone marrow, hepatic and renal function, defined as:

    1. White blood cells ≥ 4 x 109 /l
    2. Absolute neutrophil count ≥ 1.5 x 109 /l
    3. Platelets ≥ 100 x 109 /l
    4. Haemoglobin ≥10 g/dl
    5. Bilirubin < 1.25 x upper limit of normal
    6. Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal
    7. Serum creatinine ≤ 106 µmol/l
  11. Less than 10% weight loss

Exclusion Criteria:

  1. Rectal cancer no amenable to resection
  2. 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
  3. Pregnant or breast-feeding women
  4. Women oh childbearing potential unless effective methods of contraception are used
  5. 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
  6. Major trauma within the past 28 days
  7. Serious nonhealing wound, ulcer, or bone fracture
  8. Evidence of bleeding diathesis or coagulopathy
  9. No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
  10. No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
  11. No known dihydropyrimidine dehydrogenase deficiency
  12. Major surgery in the 4 weeks prior to the start of study treatment
  13. No concurrent chronic, daily treatment with aspirin (> 325 mg/day)
  14. More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes
  15. No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation
  16. No other medical history or condition that, in the opinion of the investigator, would preclude study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00847119

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Institut Català d'Oncologia-L'Hospitalet
L'Hospitalet del Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Institut Català d'Oncologia
Hoffmann-La Roche
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Principal Investigator: Ramon Salazar, Phd Institut Català d'Oncologia
Study Chair: Margarita Garcia, MD Institut Català d'Oncologia
Publications of Results:
PHASE II STUDY OF PREOPERATIVE BEVACIZUMAB, CAPECITABINE, AND RADIOTHERAPY FOR RESECTABLE LOCALLY ADVANCED RECTAL CANCER. M. Martinez Villacampa, C. Santos, M. García, V. Navarro, A. Teule, F. Losa, A. Pisa, L. Lema, S. Biondo, R. Salazar. J Clin Oncol 29: 2011 (suppl 4; abstr 516)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Institut Català d'Oncologia Identifier: NCT00847119    
Other Study ID Numbers: ML 20006. XEBERECTO/ICO/005
EudraCT number:2007-000456-13
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Keywords provided by Institut Català d'Oncologia:
resectable locally advanced adenocarcinoma of the rectum
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action