NCT01811394

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

10.1 years

First QC Date

March 9, 2013

Last Update Submit

November 29, 2023

Conditions

Sacral Chordoma

Keywords

sacral chordomachordomacarbon ion therapyproton therapyhypofractionation

Outcome Measures

Primary Outcomes (1)

  • safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique

    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

    From date of treatment start until 12 months after treatment.

Secondary Outcomes (3)

  • local progression free survival (LPFS)

    From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.

  • 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)

    From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.

Study Arms (2)

protons

EXPERIMENTAL

16x4GyE protons

Radiation: protons

Carbon ions

EXPERIMENTAL

16x4GyE carbon ions

Radiation: carbon ions

Interventions

protonsRADIATION

Treatment is performed using 16 x 4 GyE protons

protons
carbon ionsRADIATION

Treatment is performed using 16 x 4 GyE carbon ions

Carbon ions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg, Radiooncology, HIT

Heidelberg, 69125, Germany

Location

Related Publications (1)

  • Uhl M, Edler L, Jensen AD, Habl G, Oelmann J, Roder F, Jackel O, Debus J, Herfarth K. Randomized phase II trial of hypofractionated proton versus carbon ion radiation therapy in patients with sacrococcygeal chordoma-the ISAC trial protocol. Radiat Oncol. 2014 Apr 29;9:100. doi: 10.1186/1748-717X-9-100.

    PMID: 24774721BACKGROUND

MeSH Terms

Conditions

Chordoma

Interventions

Protons

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Cations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical Phenomena

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 9, 2013

First Posted

March 14, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2023

Study Completion

June 1, 2025

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations

DE(1)