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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00004384
Date of registration:	28/09/2012
Prospective Registration:	Yes
Primary sponsor:	Westdeutsches Protonentherapiezentrum Essen, Klinik für Partikeltherapie, Universitätsklinikum Essen
Public title:	Register Study Standard Proton Therapy WPE - Adults -
Scientific title:	Register Study Standard Proton Therapy WPE - Adults - - ProReg
Date of first enrolment:	01/07/2013
Target sample size:
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00004384
Study type:	observational
Study design:	Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
Phase:

Countries of recruitment
Germany

Contacts

Name:	Stefanie Schulze Schleithoff
Address:	Hufelandstr. 55 45147 Essen Germany
Telephone:	0201/723 6607
Email:	stefanie.schulze-schleithoff@uk-essen.de
Affiliation:	Westdeutsches Protonentherapiezentrum Essen

Name:	Beate Timmermann
Address:	Hufelandstr. 55 45147 Essen Germany
Telephone:	+492017236607
Email:	beate.timmermann@uk-essen.de
Affiliation:	Westdeutsches Protonentherapiezentrum Essen (WPE)

Key inclusion & exclusion criteria

Inclusion criteria: • Indication for radiotherapy was given.
• Proton therapy is conducted alternatively to conventional radiotherapy. An accountable indication according to § 80 StrlSchV has to be proposed for each patient by a specialized physician including authoritative documentation during proton therapy within the scope of patient treatment. The designated use of proton therapy is in the realm of medical treatment,
- as far as it is clinically established (e.g. according to guidelines) or
- as far as the indication and treatment scheme (fractionation, total dosis) is equivalent to the established standard of conventional photon therapy.
• Patient does not participate in clinical studies concerning proton therapy.
• No pregnancy verified. If necessary, willingness to use contraception during treatment is given.
• Patient has given informed consent for participation, data documentation, and analysis in the Register Study.

Exclusion criteria: none

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Intervention(s)

Group 1: Register Study: Data collection from patients receiving proton therapy

Primary Outcome(s)

Data documentation regarding toxicity, tumor control, and outcome during proton therapy as basis for later evaluation concerning options and benefits of proton therapy.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Westdeutsches Protonentherapiezentrum gGmbH

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 21/08/2012
Contact:

ethikkommission@uk-essen.de

Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen

+49-201-7233637

ethikkommission@uk-essen.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00004384#studyResults

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