EUCTR2018-002095-40-ES
Active, not recruiting
Phase 1
Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program.
Fundación de investigación de HM Hospitales0 sites30 target enrollmentJanuary 18, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación de investigación de HM Hospitales
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or females, aged \> or \= 18 years.
- •2\. Agree to participate and sign voluntary written ICF before any study specific
- •3\. Patients with confirmed histopathological diagnosis of rectal cancer.
- •4\. Patients with locally advanced rectal cancer T3\-T4N0M0 or TxN\+M0 and selected T2N0M0 candidates to watch \& wait program.
- •5\. Patients considered for neoadjuvant treatment according to usual clinical practice
- •may also be potential candidates.
- •6\. ECOG performance status 0 or 1\.
- •7\. Patients who can receive radiotherapy and chemotherapy.
- •8\. No prior or concurrent malignant disease unless in complete remission for more
- •than three years, except for adequately treated in situ carcinoma of the cervix, basal
Exclusion Criteria
- •1\. Patients with ECOG performance status \> or \=2\.
- •2\. T1N0M0\)or stage IV (TxNxM1\) AJCC rectal cancer.
- •3\. Any illness that the investigator considers will substantially increase the risk if the
- •patient participates in the study.
- •4\. Pregnant or breast\-feeding woman.
- •5\. Chronically active hepatitis B or C virus infection.
- •6\. Active uncontrolled infection.
- •7\. History, within last year, or presence of unstable angina, myocardial infarction,
- •symptomatic congestive heart failure or asymptomatic left ventricular ejection
- •fraction \< 50% (assessed by multiple\-gated acquisition scan or equivalent by
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Proof-of-concept study for BIVV020 in chronic inflammatory demyelinating polyneuropathy (CIDP)Chronic inflammatory demyelinatingpolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10077384Term: Chronic inflammatory demyelinating polyneuropathySystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2020-004006-54-FRSanofi-Aventis Recherche & Développement90
Active, not recruiting
Not Applicable
Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine. - Not applicableMetastatic breast cancer patients after failure to anthracyclines, taxanes and capecitabine.Classification code 10055113EUCTR2004-000572-14-DKAventis Pharmaceuticals, Inc. (a subsidiary of sanofi-aventis group)162
Active, not recruiting
Phase 1
Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine. - Not applicableMetastatic Breast Cancer Patients after failure to Anthracyclines, Taxanes and Capecitabine.Classification code 10055113EUCTR2004-000572-14-ESAventis Pharmaceuticals, Inc.162
Active, not recruiting
Not Applicable
Phase II multicenter, open label, non-randomized study of intravenous RPR109881 q 3 weeks in patients with metastatic breast cancer progressing after therapy with anthracyclines, taxanes, and capecitabine. - Not applicableEUCTR2004-000572-14-BEAventis Pharmaceuticals, Inc. (a subsidiary of sanofi-aventis group)162
Recruiting
Phase 1
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 GlomerulopathyCTIS2024-515892-36-00Region Skane30