Clinical trial NCT00847119: Xeloda and Bevacizumab to Treat Rectal Cancer
Official title: ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: rectum
adenocarcinoma
neoadjuvant
bevacizumab
capecitabine
radiotherapy
locally
advanced
resectable
resectable locally advanced adenocarcinoma of the rectum
xeberecto
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2009-02-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)
timeFrame: Surgery date
Secondary outcomes:
measure: Overall clinical response
timeFrame: Surgery date
measure: To determine the downstaging caused by treatment
timeFrame: Surgery date
measure: relapse free survival
timeFrame: Time of radiological evidence of relapse.
measure: Quantify the local control grade: R0 resections in surgery
timeFrame: Surgery date
measure: Local relapse and distant relapse rates
timeFrame: Relapse date
measure: To determine the security profile of this neoadjuvant treatment (radio- chemotherapy)
timeFrame: From date of register to surgery date
measure: Surgery complication rate
timeFrame: During surgery admission.
measure: To determine the angiogenic profile changes in tumour.
timeFrame: 15 days, 6 weeks and 4 months
Other outcomes:
Locations:
city: L'Hospitalet del Llobregat
country: Spain
facility: Institut Català d'Oncologia-L'Hospitalet
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia
name: Ramon Salazar, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Català d'Oncologia
name: Margarita Garcia, MD
role: STUDY_CHAIR
References:
citation: 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.