Clinical trial · Interventional
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size
NCT00332969CI-TRIAL-00026714completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Octreotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sandostatin
- interventionNames
- Drug: Octreotide
Primary outcomes (1)
- measure
- Shrinkage of tumor size and diameter of 3 respectively 6 months
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
- Resection status after 3 respectively 6 months
- timeFrame
- 3 - 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients aged \>18 years 2. Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected. 3. Positive result in SMS-szintigraphy, 4. Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens. 5. Patients with and without thymoma associated paraneoplastic syndrome 6. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1. Exclusion Criteria: 1. Performance status 0,1, or 2 (ECOG) 2. Symptomatic cholelithiasis, 3. Pretreatment with octreotide (longn acting release) within the 3 months 4. Patient has received any other investigational agents within 28 days of first day of study drug dosing 5. Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed 6. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) Other protocol-defined inclusion/exclusion criteria apply
References
Publications (1)
- RESULTKirzinger L, Boy S, Marienhagen J, Schuierer G, Neu R, Ried M, Hofmann HS, Wiebe K, Strobel P, May C, Kleylein-Sohn J, Baierlein C, Bogdahn U, Marx A, Schalke B. Octreotide LAR and Prednisone as Neoadjuvant Treatment in Patients with Primary or Locally Recurrent Unresectable Thymic Tumors: A Phase II Study. PLoS One. 2016 Dec 16;11(12):e0168215. doi: 10.1371/journal.pone.0168215. eCollection 2016. PMID 27992479