Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 site in 1 country90 target enrollmentDecember 2009

ConditionsRectal Cancer

InterventionsBevacizumab + Capecitabine + Radiotherapy Capecitabine + Radiotherapy

DrugsBevacizumab + Capecitabine + Radiotherapy Capecitabine + Radiotherapy

Overview

Phase: Phase 2
Intervention: Bevacizumab + Capecitabine + Radiotherapy
Conditions: Rectal Cancer
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Enrollment: 90
Locations: 1
Primary Endpoint: Rate complete pathologic responses
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

August 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Age ≥18 years
•Histologically confirmed carcinoma of the rectum
•Localized and resectable rectal cancer
•No metastatic disease
•Measurable disease
•Life expectancy more than 4 months
•Non prior treatment for rectal cancer
•Adequate haematological function: leu ≥ 4x 109 /l, Hb ≥10 gr/dl, neutropils≥ 1,5 x 109 /l and platelets ≥100 x 109 /l
•Adequate renal function: creatinine ≤ 106 umol/l or calculated creatinine clearance \> 50 mL/min

Exclusion Criteria

•Unresectable rectal cancer
•Past or current history (within the last 5 years prior to treatment start) of other malignancies.
•Patients of childbearing potential not willing to use effective means of contraception.
•Clinically significant cardiovascular disease
•Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
•Patients subjected to organ allografts who require immunosuppressive treatment.
•Severe, non-cicatrized osseous fractures, wounds or ulcers.
•Indications of hemorrhagic diathesis or coagulopathy.
•Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant diseases.
•History of unexpected severe reactions to treatment with fluoropyrimidines or known deficiency dihydropyrimidine dehydrogenase deficiency (DPD).

Arms & Interventions

A

Bevacizumab + Capecitabine + Radiotherapy

Intervention: Bevacizumab + Capecitabine + Radiotherapy

B

Capecitabine + Radiotherapy

Intervention: Capecitabine + Radiotherapy

Outcomes

Primary Outcomes

Rate complete pathologic responses

Time Frame: 17 months

Secondary Outcomes

Rate of local and distant recurrence at 3 and 5 years(78 months)
R0 resection rate.(17 months)
Adverse events(17 months)
Molecular predictive markers: changes in angiogenic parameters, vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptors, microvessel quantification and angiopoietin-2 (Ang-2)(17 months)
Overall survival at 3 and 5 years(78 months)
Rate of sphincter preservation(17 months)
Disease free survival at 3 and 5 years(78 months)
Rate of surgery complications(17 months)