This trial is active, not recruiting.

Condition rectal cancer
Treatments bevacizumab + capecitabine + radiotherapy, capecitabine + radiotherapy
Phase phase 2
Sponsor Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Collaborator Hoffmann-La Roche
Start date December 2009
End date January 2013
Trial size 90 participants
Trial identifier NCT01043484, EudraCT: 2009-010192-24, TTD-08-05


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Bevacizumab + Capecitabine + Radiotherapy
bevacizumab + capecitabine + radiotherapy
Bevacizumab (5 mg/kg; days 1, 15 and 29) Capecitabine (825 mg/m2/12h, 5 days/w) Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)
(Active Comparator)
Capecitabine + Radiotherapy
capecitabine + radiotherapy
Capecitabine (825 mg/m2/12h, 5 days/w) and Radiotherapy (45 Gy in sessions of 1.8 Gy 5 times/w for 5 weeks)

Primary Outcomes

Rate complete pathologic responses
time frame: 17 months

Secondary Outcomes

Disease free survival at 3 and 5 years
time frame: 78 months
Rate of local and distant recurrence at 3 and 5 years
time frame: 78 months
Overall survival at 3 and 5 years
time frame: 78 months
R0 resection rate.
time frame: 17 months
Adverse events
time frame: 17 months
Rate of surgery complications
time frame: 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)
time frame: 17 months
Rate of sphincter preservation
time frame: 17 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Written informed consent - Age ≥18 years - ECOG ≤ 1 - 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 - Adequate liver function: AST, ALT and alkaline phosphatase ≤2.5 x UL, bilirubin ≤1.5 x UL - Adequate nutritional weight loss <10% of regular weight and albumin ≥ 35 g/l 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). - Patients subjected to a major surgical procedure, open biopsy or who have had significant traumatic lesions within the 28 days prior to beginning the treatment of the study or in whom it is foreseen that a major surgical procedure will be necessary during the course of the study; fine-needle aspiration within the 7 days prior to beginning the treatment of the study. - Current or recent use (within the 10 days prior to beginning the treatment of the study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents. The use of low doses of warfarin is allowed, with an International Normalized Ratio [INR] of < 1.5. - Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid anti-inflammatory medications (which inhibit the platelet function at doses used for treating chronic inflammatory diseases). - Patients who have received any drug or agent/procedure under research, i.e., who have participated in another clinical trial during the 4 weeks prior to beginning the treatment with the medications of the study - Any psychological, familiar conditions suggesting that the patient will not be able to complete the study

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD).