Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or … (NCT02021942) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size
Germany16 participantsStarted 2012-03
Plain-language summary
This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230 LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The purpose of this trial is a proof of concept.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female patients aged ≥18 years
* Diagnosis of thymoma as assessed by biopsy and/or szintigraphy
* Inoperability of thymoma or loco-regional metastases. Inoperability is defined as at least adherence of the tumor to the neighbored organs, suspicious to infiltrate neighbored organs or local metastasis so that R0 resection can not be expected and /or local recurrence of thymic tumor
* Tumor stage: Thymomas of all WHO based histological subtypes (WHO A, AB, B1, B2, B3) (Rosai, 1999; Travis 2004) at Masaoka stage II to IVa based on histological examination of resection specimens or core biopsies.
* Patients with and without thymoma associated paraneoplastic syndrome.
* Performance status 0,1, or 2 (ECOG)
* Patients for whom written informed consent to participate in the study has been obtained
Exclusion Criteria:
* Patients having received radiolabeled somatostatin analogue therapy within the 6 months or any cytotoxic chemotherapy or interferon therapy within the 2 months prior to recording baseline symptoms
* Patients who have undergone major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months before recording baseline symptoms
* Patients who have received radiotherapy for any reason within the last 4 weeks and must have recovered from any side effects of radiotherapy before recording baseline symptoms
* Patients who are not biochemically euthyroid
* Diabetic patients on an…
What they're measuring
1
Percent Change in Tumor Volume From Baseline to EOS