Clinical trial NCT02359474: Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin
Official title: Trabectedin Combined With Regional Hyperthermia as Second Line Treatment for Adult Patients With Advanced Soft-tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma
Keywords: high-risk soft tissue sarcoma
trabectedin
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma
* Patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without RHT
* Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome
* After macroscopic incomplete resection or marginal resection (tumor-free margins \< 1 cm)
* Prior chemotherapy, including anthracyclines with/without ifosfamide (with or without RHT) or patients who cannot be given these medicines
* At least one tumor manifestation which is eligible for hyperthermia
* Performance status (ECOG) 0,1 or 2
* More than 3 weeks from last treatment
* Neutrophil count ≥ 1,5 G/l, hemoglobin ≥ 9 g/dl, platelets ≥ 100 G/l
* Albumin ≥ 25 g/l, total bilirubin ≤ 1 x ULN, ALT/AST ≤ 2.5 x ULN, AP ≤ 2.5 x ULN, Cockroft and Gault's calculated creatinine clearance ≥ 30 ml/min, CPK ≤ 2.5 x ULN
* Patients with the ability to follow study instructions and likely to attend and complete all required visits
* Written informed consent of the subject

Exclusion Criteria:

* Uncontrolled infection (e.g. active viral hepatitis)
* Unstable cardiac status
* Peripheral neuropathy \> grade 2
* Known or persistent abuse of medications, drugs or alcohol
* Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ)
* Prior therapy with Tr or known history of hypersensitivity to drugs with a similar chemical structure
* Pregnancy or breast-feeding
* Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration
* Uncontrolled CNS-metastases
* Medical or technical impossibility for hyperthermia to heat the major target lesion

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Secondary outcomes:
measure: Radiological response according to RECIST
timeFrame: planned after 46 events after start of recruitment which are expected to occur after 27 month
measure: Overall Survival (OS)
timeFrame: planned after 46 events after start of recruitment which are expected to occur after 27 month
measure: Treatment related toxicity (hematological, renal, hepatic, others)
timeFrame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians University of Munich, Klinikum Großhadern
state: Bavaria
city: Bad Saarow
country: Germany
facility: Helios Klinikum Bad Saarow
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Rolf Issels, MD
role: PRINCIPAL_INVESTIGATOR
References: