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Trial record 18 of 27 for:    "chordoma"

Ion Irradiation of Sacrococcygeal Chordoma (ISAC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth - Dr. J. Debus, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01811394
First received: March 9, 2013
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.


Condition Intervention Phase
Exposure to Artificially Accelerated Beams of Ionized Particles Generated by Synchrotrons
Radiation: protons
Radiation: carbon ions
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • safety and feasibility of hypofractionated irradiation in patients with sacrococygeal chordoma using ions (protons or carbon ions) in raster scan technique [ Time Frame: From date of treatment start until 12 months after treatment. ]
    The evaluation is based on incidence of Grade 3-5 toxicity (NCI-CTC-AE) and/or discontinuation of the treatment for any reason. Endpoint is the proportion of treatments without Grade 3-5 toxicity (NCI-CTC-AE) up to 12 months after treatment and/or discontinuation of the treatment for any reason


Secondary Outcome Measures:
  • local progression free survival (LPFS) [ Time Frame: From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months. ]
    local progression free survival (LPFS) is determined from start of treatment until local progression in imaging (>10% size increase)

  • Overall survival (OS) [ Time Frame: From date of treatment start until the date of death from any cause assessed up to 12 months. ]
    Further objectives are overall survival (OS) from date of treatment start until the date of death from any cause assessed up to 12 months

  • Quality of life (QoL) [ Time Frame: From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment. ]
    Quality of life (QoL) evaluated with EORTC-QLQ30 questionnaire.


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protons
16x4GyE protons
Radiation: protons
Experimental: Carbon ions
16x4GyE carbon ions
Radiation: carbon ions

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Histological confirmation of sacrococcygeal chordoma
  • Karnofsky performance status ≥ 70%
  • Patients age 18 - 80 years
  • Macroscopic tumour (MRI)
  • Written informed consent

Exclusion Criteria:

  • Lack of macroscopic tumour
  • Tumor extension in craniocaudal direction >16cm
  • Metal implants at the level of the tumor which could influence the treatment planning
  • Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
  • Prior radiotherapy of the pelvic region
  • Simultaneous participation in another trial that could influence the results of the study
  • Active medical implants without treatment approveal at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811394

Contacts
Contact: Matthias Uhl, Dr. +49 6221 568201 Matthias.uhl@med.uni-heidelberg.de
Contact: Klaus Herfarth Herfath, Prof.Dr. +49 6221 568201 Klaus.herfarth@med.uni-heidelberg.de

Locations
Germany
University of Heidelberg, Radiooncology, HIT Recruiting
Heidelberg, Germany, 69125
Contact: Matthias Uhl, Dr.    +49 6221 568201    Matthias.uhl@med.uni-heidelberg.de   
Contact: Klaus Herfarth, Prof.Dr.    +49 6221 568201    Klaus.herfarth@med.uni-heidelberg.de   
Principal Investigator: Klaus Herfarth, Prof.Dr.         
Sponsors and Collaborators
Heidelberg University
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klaus Herfarth - Dr. J. Debus, Prof. Dr., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01811394     History of Changes
Other Study ID Numbers: ISAC-01
Study First Received: March 9, 2013
Last Updated: March 12, 2013
Health Authority: Germany: Federal Office for Radiation Protection

Keywords provided by Heidelberg University:
sacral chordoma
chordoma
carbon ion therapy
proton therapy
hypofractionation

Additional relevant MeSH terms:
Chordoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

ClinicalTrials.gov processed this record on November 25, 2014