Background: Metastatic soft tissue sarcomas (STSs) management remains an unmet medical need. We assessed the activity and safety of regorafenib in patients with metastatic non-adipocytic STS who were previously treated with both chemotherapy and pazopanib.
Patients And Methods: This double-blind, placebo-controlled, multicenter comparative randomized phase II trial included patients with histologically proven advanced and inoperable STS.
The regulatory framework of clinical research is necessary to ensure the protection of participants and to define the actors and their responsibilities. Although main principles have been set up in 1947 with the Nuremberg Code, this regulatory framework is relatively recent in Europe: development of national regulations in the years 1980-1990, first European Directive regarding clinical trials in 2001. In France, as 2006 was marked by the implementation of this first "Clinical trials Directive", the end of the year 2016 and the following months were marked by the enforcement of the Jardé law (previously modified in order to reinforce the regulatory requirements following the death of an healthy volunteer in a clinical trial).
View Article and Find Full Text PDFPurpose Of Review: We aimed to summarize the recent reflections and collaborative initiatives pertaining to the definition of more appropriate eligibility criteria in cancer clinical trials.
Recent Findings: There is an intrinsic tension between two opposite purposes when it comes to defining eligibility criteria: on the one hand, participants must be protected, and on the other, the study population must be defined as accurately as possible. However, stringent eligibility criteria jeopardize the feasibility of trials, and, consequently, the generalizability of trial results.
Background: Few reports describe how adverse events (AEs) are reported in cancer surgery trials.
Materials And Methods: We systematically reviewed 179 consecutive study reports issued between January 1, 1990 and November 15, 2014, which investigated surgery in oesophago-gastric (OG) or gynecologic (GY) cancer patients. Based on the reviewed reports, we assessed how AEs were reported according to CONSORT statement.
Background: Angiogenesis, among other signaling pathways, plays a key-role in sarcoma biology. Regorafenib (RE) has recently been shown to be effective in imatinib and sunitinib-refractory GIST in a phase III trial.
Methods/design: We are conducting an international trial (France, Austria and Germany) consisting in 4 parallel double-blind placebo-controlled randomized (1/1) phase II trials to assess the activity and safety of RE in doxorubicin-refractory STS (ClinicalTrials.
Background: Selecting patients for phase I trials in order to investigate cytotoxic agents is challenging, since there is no clear and reliable guidance to estimate life expectancy among these patients. We retrospectively assessed prognostic factors in cancer patients screened for Phase1 trials between October 1997 and October 2002.
Methods: 148 consecutive patients, screened for inclusion in phase I trials investigating cytotoxic agents, were included in the present study.