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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332969

Enrollment

Registered

2006-06-02

Start date

2005-09-30

Completion date

Unknown

Last updated

2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thymoma

Keywords

Open label, phase II, disease, clinical trial, Octreotide, thymoma, cancer, tumor

Brief summary

This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.

Interventions

DRUGOctreotide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Shrinkage of tumor size and diameter of 3 respectively 6 months	6 months

Secondary

Measure	Time frame
Resection status after 3 respectively 6 months	3 - 6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026