Clinical trial NCT00828672: Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer
Official title: A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Rectal Cancer
Keywords: bevacizumab
capecitabine
radiation therapy
oxaliplatin
multimodality treatments
TME (total mesorectal excision)
Axe Beam
rectal cancer
neoadjuvant
pathological complete response
postoperative complications
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2009-01-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Detailed description: See Synopsis

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of rectum measurable (RECIST), locally advanced (defined by MRI - Tumour beyond mesorectal fascia (T4) or Tumour ≤ 2 mm from mesorectal fascia or T3 tumour \< 5 cm from anal verge
* Patient is at least 18 years of age
* Good organ function

Exclusion Criteria:

* Evidence of distant metastases
* Contraindication for bevacizumab
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery.
timeFrame: 4 months
Secondary outcomes:
measure: Number of Participants With Histopathologic R0 and Negative CRM Resection
timeFrame: 4 months
measure: Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery.
timeFrame: 4 months
measure: Clinical Response Rate
timeFrame: 3 months
measure: Types and Numbers of Adverse Events - General Overview
timeFrame: continuous up to 1 year
measure: Recurrence Rates and Disease Free Survival
timeFrame: up to 5 years
measure: Death Rates and Overall Survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ St- Lucas
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liege
country: Belgium
facility: C.H.U. Sart-Tilman
city: Namur
country: Belgium
facility: Clinique Sainte Elisabeth
city: Roeselare
country: Belgium
facility: H. Hartziekenhuis
Study officials:
affiliation: UZ Leuven
name: Eric Van Cutsem, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: