Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00010745

Trial Description

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Title

Trabectedin Combined With Regional Hyperthermia as Second Line Treatment for Adult Patients With Advanced Soft-tissue Sarcoma

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Trial Acronym

HyperTET

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00010745
  •   2016/06/29
  •   2014/11/10
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02359474  (ClinicalTrials.gov)
  •   HyperTET  (Ludwig-Maximilians - University of Munich)
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Health Condition or Problem studied

  •   Sarcoma
  •   C49 -  Malignant neoplasm of other connective and soft tissue
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Interventions/Observational Groups

  •   Drug: Trabectedin
  •   Genetic: DNA double-strand breaks
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

- Progression-free Survival (PFS); time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month

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Secondary Outcome

- Overall Survival (OS); time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2015/01/31
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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 and 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 and ifosfamide (with or without RHT) or
patients who cannot be given these medicines

- Oligometastasis (≤ 5 lesions)

- 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

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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

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Addresses

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    • Ludwig-Maximilians - University of Munich
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Ludwig-Maximilians - University of Munich
    • Eric Kampmann, MD 
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • Eric Kampmann, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2016/06/22
* This entry means the parameter is not applicable or has not been set.