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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01043484
Other study ID # TTD-08-05
Secondary ID EudraCT: 2009-01
Status Completed
Phase Phase 2
First received December 30, 2009
Last updated October 18, 2016
Start date December 2009
Est. completion date August 2016

Study information

Verified date October 2016
Source Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date August 2016
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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)
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)

Locations

Country Name City State
Spain Spanish Cooperative Group for Gastrointestinal Tumour Therapy Madrid

Sponsors (2)

Lead Sponsor Collaborator
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate complete pathologic responses 17 months No
Secondary Disease free survival at 3 and 5 years 78 months No
Secondary Rate of local and distant recurrence at 3 and 5 years 78 months No
Secondary Overall survival at 3 and 5 years 78 months No
Secondary R0 resection rate. 17 months No
Secondary Adverse events 17 months Yes
Secondary Rate of surgery complications 17 months Yes
Secondary 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 No
Secondary Rate of sphincter preservation 17 months No
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