Status:
UNKNOWN
VASCular Impact of Angiogenic Treatment in Patients With Advanced Colorectal Cancer
Lead Sponsor:
University Hospital, Rouen
Conditions:
Oncology
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Antiangiogenic treatments are used in many tumor locations such as metastatic colorectal cancer (mCRC) with a significant improvement in carcinological results on overall survival and / or progression...
Eligibility Criteria
Inclusion
- Patient at least 18 years old,
- Patient with colorectal cancer of the adenocarcinoma type, stage IV, histologically confirmed, mutated or wild tumor RAS status (exons 2, 3 and 4 of the KRAS and NRAS genes), mutated or wild BRAF status, naive in antineoplastic treatment
- Patient eligible to start systemic carcinological treatment including bevacizumab in combination with chemotherapy based on IV fluoropyrimidine,
- General condition WHO grade less than or equal to 3,
- Life expectancy greater than 4 months,
- Patient who has read and understood the information letter and signed the consent form,
- Patient affiliated to a social security scheme,
- Effective contraception (see WHO definition) in women of childbearing age (negative pregnancy test). For postmenopausal women, a confirmatory diagnosis should be obtained (amenorrhea not medically induced for at least 12 months before the inclusion visit).
Exclusion
- Previous exposure to anti-VEGF,
- Exposure to treatment for metastatic disease in the 12 months prior to inclusion,
- Other histologically proven neoplasia not considered in complete remission or considered in complete remission for less than two years,
- Bilateral carotid breath,
- Absence of peripheral pulse of the two upper limbs,
- Contraindication to AVASTIN 25 mg / ml concentrate for solution for infusion:
- Hypersensitivity to the active substance or to any of the excipients,
- Hypersensitivity to Chinese hamster ovarian cell products or other human or humanized recombinant antibodies,
- Patients:
- having undergone a major surgical intervention in the 28 days preceding the inclusion or as long as the surgical wound is not completely healed,
- Unhealed ulcer or wound,
- having uncontrolled pre-existing hypertension (PAS\> or = 170 mm Hg after three repeated measurements at rest),
- having a history of arterial thromboembolism (transient ischemic attack (TIA), cardiovascular accident (stroke) or recent (\<6 months) and / or symptomatic myocardial infarction (MI)
- having had an invasive dental procedure in the 28 days preceding inclusion,
- with known proteinuria\> 2g / 24h or in whom proteinuria\> 2g / 24h is discovered in the case of a positive urine strip 3+ for proteins (excluding urinary tract infection),
- on aspirin\> 325 mg / d,
- with a colonic prosthesis in place,
- Systemic treatment with anti-EGFR monoclonal antibodies,
- Presence or history of lymphedema of the bilateral upper limbs,
- Patient with poor understanding of spoken or written French,
- Patient deprived of liberty by an administrative or judicial decision or patient placed under the protection of justice, under guardianship or curatorship,
- Pregnant or lactating woman or wishing to breastfeed within 6 months after the last administration of the treatment,
- Patient participating in another drug trial / having participated in another drug trial within 30 days of inclusion,
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for his participation
Key Trial Info
Start Date :
May 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 5 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04813913
Start Date
May 5 2019
End Date
November 5 2022
Last Update
March 24 2021
Active Locations (1)
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1
CHU de ROUEN
Rouen, France