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Ion Irradiation of Sacrococcygeal Chordoma (ISAC)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Klaus Herfarth, MD, Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01811394
First received: March 9, 2013
Last updated: May 1, 2017
Last verified: May 2017
  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
Sacral Chordoma Radiation: protons Radiation: carbon ions Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 Klaus Herfarth, MD, Heidelberg University:

Primary Outcome Measures:
  • safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal 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: June 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protons
16x4GyE protons
Radiation: protons
Treatment is performed using 16 x 4 GyE protons
Experimental: Carbon ions
16x4GyE carbon ions
Radiation: carbon ions
Treatment is performed using 16 x 4 GyE carbon ions

Detailed Description:
The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 approval 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

Publications:
Responsible Party: Klaus Herfarth, MD, Prof. Dr., Heidelberg University
ClinicalTrials.gov Identifier: NCT01811394     History of Changes
Other Study ID Numbers: ISAC-01
Study First Received: March 9, 2013
Last Updated: May 1, 2017

Keywords provided by Klaus Herfarth, MD, Heidelberg University:
sacral chordoma
chordoma
carbon ion therapy
proton therapy
hypofractionation

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

ClinicalTrials.gov processed this record on June 28, 2017