Clinical trial NCT00557713: XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Official title: Treatment of Induction With XELOX-Bevacizumab in Locally Advanced Rectal Adenocarcinoma: Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Neoplasms
Locally Advanced Rectal Adenocarcinoma
Lead sponsor: Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2007-11-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pathological complete response rate of addition of bevacizumab to induction therapy (xelox) and concomitant treatment (capecitabine+radiotherapy), followed by surgery.


Eligibility criteria: Inclusion Criteria:

* Written informed consent from patients who are able to understand the study request
* Histologically confirmed diagnosis of locally advanced rectal adenocarcinoma; ≤12 cm from the anal margin; T3, operable T4 or TxN+
* Karnofsky PS Index ≥ 70%
* Life expectancy \> 6 months
* Adequate bone marrow, liver and renal function: ANC ≥ 1.5 x 10e9/l; Platelets ≥ 100 x 10e9/l; Hb ≥ 9g/dl; INR ≤ 1.5; Bilirubin ≤ 1.5 x ULN; ALT and/or AST ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis); Alkaline phosphatase ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis) or ≤ 10 x ULN (in case of bone metastasis); Creatinine clearance (Cockcroft-Gault) ≥ 30 ml/min or seric creatinine ≤ 1.5 x ULN

Exclusion Criteria:

* Distant metastases; previous neoplasm during last 5 years or previous infiltrating neoplasm; previous treatment with radiotherapy or study drugs; recruited for other clinical trial in 4 weeks before study entry
* Surgery, open biopsy or traumatic injury in 4 weeks before study entry; fine-needle aspiration in 7 days before study entry; major surgery planned during study
* Previous heart disease or uncontrolled hypertension, previous hemorrhagic diathesis or coagulopathy; full-dose oral or parenteral anticoagulant or thrombolytic agent (low-dose warfarin is allowed, INR ≤ 1.5); chronic use of high-dose aspirin (\<325mg/day) or non-steroidal anti-inflammatory treatment
* No integrity of the upper gastrointestinal tract, malabsorption syndrome or unable to take oral drugs
* Pregnant or lactating patients; SNC disease; allogeneic transplant with immunosuppressive drugs; bone fracture not healed, wound or severe ulcers; uncontrolled intercurrent severe infections; previous related-fluoropyrimide SAEs or DPD deficiency

Primary outcomes:
measure: Pathologic Complete Response Rate
timeFrame: after concomitant CT-RT treatment
Secondary outcomes:
measure: Complete Resection (R0) Rate
timeFrame: after surgery
measure: Disease Free Survival
timeFrame: from complete response to relapse or disease-related death
measure: Time to Failure Treatment
timeFrame: from first treatment dose to drop out of the study
measure: Metastatic or Local Recurrence
timeFrame: during study
measure: Toxicity Evaluation
timeFrame: during study
measure: Surgical Morbility
timeFrame: during surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: ACROSS
Study officials:
affiliation: Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
name: Miquel Nogué, MD
role: STUDY_CHAIR
References: