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ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece)

Outcome Time Frame:

Surgery date

Safety Issue:

No

Principal Investigator

Ramon Salazar, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Català d'Oncologia

Authority:

Spain: Spanish Agency of Medicines

Study ID:

ML 20006. XEBERECTO/ICO/005

NCT ID:

NCT00847119

Start Date:

September 2007

Completion Date:

September 2013

Related Keywords:

  • Rectal Cancer
  • rectum
  • adenocarcinoma
  • neoadjuvant
  • bevacizumab
  • capecitabine
  • radiotherapy
  • locally
  • advanced
  • resectable
  • resectable locally advanced adenocarcinoma of the rectum
  • xeberecto
  • Rectal Neoplasms

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