ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Rectal Cancer
- Sponsor
- Institut Català d'Oncologia
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Bevacizumab
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.
Intervention: capecitabine (Xeloda)
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.
Intervention: Rectal Radiotherapy
Outcomes
Primary Outcomes
Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)
Time Frame: Surgery date
Secondary Outcomes
- 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)
- To determine the security profile of this neoadjuvant treatment (radio- chemotherapy)(From date of register to surgery date)
- Surgery complication rate(During surgery admission.)
- To determine the angiogenic profile changes in tumour.(15 days, 6 weeks and 4 months)