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Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging

Phase 2
18 Years
Open (Enrolling)
Rectum Cancer

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Trial Information

Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging

XELOX / Bevacizumab will be administrated for 3 cycles over a 9 week period. XELOX
without Bevacizumab will be administrated for an additional cycle over a 4 week period.
Patients will undergo re-staging within 3 weeks of their 4th cycle of XELOX. This will
include MRI of the pelvis. If the reassessment reveals that there has been no disease
progression compared to the pre-treatment evaluation and the patient remains a candidate for
an R0 resection, the patient will proceed to definitive rectal cancer surgery within 4
weeks from the last chemotherapy dose. If the surgical oncologist's reassessment reveals
that the patient is not a candidate for an R0 resection, the patient will proceed to
standard pre-operative radiation with synchronous Capecitabine.

Inclusion Criteria:

- Patient ≥18 years

- Tumor biopsy with histopathologic confirmation of rectal adenocarcinoma as primary

- Patient with measurable disease at the baseline visit

- T3 tumor that meets all the following criteria in high-resolution magnetic resonance
imaging (MRI) (3-mm slices) of the pelvis: distal border of tumor more than 5cm form
the external edge of the anus and below the sacral promontory (located in the anatomy

- Candidate for complete surgical resection (R0) with sphincter preservation surgery,
prior to the administration of any therapy

- Candidate for systemic therapy with XELOX/BVZ

- ECOG: 0-2

- ANC≥1.5 cells/mm3, Hb>8.0 g/dL, platelets>150,000/mm3 in 2 previous weeks

- Patient who signed the informed consent

Exclusion Criteria:

- Stage T4.

- Distant metastases

- Tumor with an intraperitoneal distal border

- Tumor presenting initially in a low location and judged, prior to any treatment, to
require abdominoperineal resection

- Previous chemotherapy for colorectal cancer or incomplete recovery from oncologic
surgery or other previous major surgery that, in the opinion of the investigator,
precludes the use of a combined modality therapy

- Serum creatinine <1.5 ULN

- Patient who has received previous pelvic radiotherapy

- Patient with an uncontrolled infection

- Presence of a high degree of obstruction (intestinal lumen ≤ 1 cm), unless the
patient has undergone protective surgical bypass or an endoscopic stent procedure

- Pt with a history of an arterial thromboembolic event during the previous year.This
includes angina (stable or unstable),myocardial infarction (MI),cerebrovascular
accident (CVA),or other relevant history in the opinion of the investigator.Note: A
patient with a history of thrombotic events, such as deep venous thrombosis,
pulmonary embolism, MI or ACV, within the 6 months preceding recruitment may be
considered for participation in the clinical trial if they are receiving stable doses
of anticoagulant therapy. Similarly, patients being anticoagulated for atrial
fibrillation or other conditions can participate if they are receiving a stable
dosage of anticoagulant therapy. Clinicians must consider the higher risk of therapy
with BVZ among patients with a history of thromboembolic disorders so the decision to
allow the patients to participate remains at the discretion of the physician

- Previous treatment with another investigational antitumoral therapy in the 30 days
prior to beginning treatment

- History of previous malignancy in the past 5 years, excepting basocellular or
squamous cell skin cancer, or properly treated cervix cancer in situ

- Woman with a positive pregnancy test in urine or serum during recruitment, prior to
the administration of the study medication, or within 72 hours of beginning to take
the study medication, or a woman who is nursing

- WOCBP who does not wish to use or cannot use an effective contraceptive method to
avoid pregnancy during the complete study period up to 4 weeks after ending the
study.Male subjects also must agree to use an effective method of contraception.Note:
WOCBP refers to any woman who has experienced menarche and has not undergone
successful surgical sterilization or is not postmenopausal (defined as amenorrhea≥12
consecutive months,or women with hormonal replacement therapy and documented serum
levels of follicle stimulating hormone).Even women who are using oral, implanted or
injectable contraceptive hormones, mechanical products such as an intrauterine device
or barrier methods to prevent pregnancy,or who practice abstinence or have a sterile
partner, must be assumed to be WOCBP

- Patient with any other condition or concurrent medical or psychiatric disease who,in
opinion of the investigator, is not eligible to enter the study

- Known hypersensitivity to any component of the study drug (XELOX/bevacizumab) or

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria

Outcome Time Frame:

Until the end of study

Safety Issue:


Principal Investigator

Carlos Fernández Martos, Oncologist

Investigator Role:

Study Chair

Investigator Affiliation:

Instituto Valenciano de Oncología (IVO)


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

March 2009

Completion Date:

June 2014

Related Keywords:

  • Rectum Cancer
  • rectum
  • intermediate risk cancer rectum
  • neoadjuvant
  • Rectal Neoplasms