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Pituitary Adenomas clinical trials

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NCT ID: NCT04244708 Not yet recruiting - Pituitary Adenomas Clinical Trials

The Effect of Chemoradiotherapy in Patients With Refractory Pituitary Adenomas

Start date: February 10, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study was to determine whether radiotherapy combined with Temozolomide is more effective than radiotherapy alone in the treatment of patients with refractory pituitary adenomas. The Basic treatment was Radiotherapy over a period of six weeks, for a total dose of 54 Gy. The150 participants were randomized to use either radiotherapy plus Temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), or radiotherapy plus placebo for 6 weeks. After a 4-week break, followed by six cycles of placebo or adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle). The primary end point was Objective Response rate, the second end point was PFS. Greater response was anticipated in patients treated with Temozolomide+ radiotherapy than radiotherapy alone.

NCT ID: NCT02803697 Completed - Pituitary Adenomas Clinical Trials

Predictive Factors of Recurrence of Non Functioning Pituitary Adenomas : a Retrospective Study of 220 Patients in the Reims University Hospital, France

Start date: November 2015
Phase:
Study type: Observational

Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient.

NCT ID: NCT01442220 Recruiting - Pituitary Adenomas Clinical Trials

Genome-wide Association Study of Pituitary Tumors

Start date: September 2011
Phase: N/A
Study type: Observational

Pituitary adenomas is a very common disease, but the cause and genetics hasn't been identified. The investigators are going to use genome-wide association study to identify genes that may be related to pituitary adenomas.

NCT ID: NCT01377701 Recruiting - Pituitary Adenomas Clinical Trials

The Predictive Factors of Vision Recovery in Patients With Pituitary Tumor

Start date: June 2011
Phase: N/A
Study type: Observational

Pituitary adenomas can cause compression of optic nerves and chiasm, which will lead to damage of vision. This study aims to evaluate the predictive factors for recovery of vision in patients with pituitary adenomas following trans-sphenoidal surgery.

NCT ID: NCT00939523 Completed - Pituitary Adenomas Clinical Trials

Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

Start date: July 2009
Phase: Phase 2
Study type: Interventional

This study focuses on new therapies for a challenging disease in pituitary medicine, that of aggressive pituitary tumors which have limited therapeutic options beyond standard surgical, radiotherapy, and select medical therapies, each incurring significant morbidity and mortality, and each not optimally effective. To improve this gap in knowledge, we seek to translate findings from the laboratory into clinical practice and hone in on therapies directed at pituitary molecular targets, namely ErbB receptors. We have shown that human prolactinomas express nuclear EGFR and membranous ErbB2, ErbB3 and ErbB4, and expression correlates with tumor invasion. Pituitary tumor cell lines transfected with EGFR and ErbB2 translated to downstream effects on prolactin (PRL) gene expression and secretion,as well as cell proliferation. Animal models implanted with these cell lines developed larger tumors and PRL elevations. Treatment with ErbB tyrosine kinase inhibitors (TKIs) led to regression of tumors xenografted into these animals and attenuated PRL secretion. Primary culture of human prolactinomas confirmed expression of ErbB receptors and inhibitory effects of TKIs on PRL secretion and cell proliferation. Based on these exciting preliminary data, the objective of this new proposal is to conduct a Phase IIa clinical trial as a trenchant test of our translational hypothesis that tyrosine kinase inhibition constitutes highly effective targeted biologic therapy for these hitherto refractory pituitary adenomas. Specifically, our aims are to test the: 1) efficacy of TKI therapy with a clinical trial; 2) threshold level of tumor receptor expression to achieve TKI clinical response. Nineteen subjects will be treated with lapatinib for 6 months in combination with their current dopamine agonist therapy, with monthly measurements of PRL levels and MRI imaging every 3 months to evaluate the primary endpoints of achieving 40% reduction in tumor size and 50% reduction in PRL and secondary endpoints of radiologic stabilization and/or reduction and PRL normalization. Mean ErbB receptor protein expression will be compared between responders to lapatinib and non-responders by immunohistochemistry in pituitary tumor samples of these subjects collected from prior surgeries.