Clinical Investigation Plan (CIP) for other clinical investigations on the safety and efficacy of helium ion radiotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038543

Enrollment

Registered

2025-11-25

Start date

2024-07-04

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with tumor diseases and an indication for radiotherapy

Interventions

Group 1: Adjuvant, additive, or definitive radiotherapy with helium ions. Dose and fractionation do not deviate from the usual radiotherapy treatment standards established for the respective disease.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Patients with cancer and an indication for radiotherapy - CI >60% or ECOG 0/1 - Age >18 years - Capacity to consent and written informed consent

Exclusion criteria

Exclusion criteria: - Patient participation in another clinical trial if further experimental therapy is necessary as a result, or if the therapies/study protocols are mutually exclusive - Conditions that prevent the individual from understanding the nature, scope, and potential consequences of the clinical trial - Minors - Pregnancy - Lack of written informed consent - Previous radiation therapy in the area to be irradiated - Active medical implants for which no authorization for ion beam therapy exists at the time of treatment (e.g., pacemaker, defibrillator, etc.) - Contraindication to MRI imaging

Design outcomes

Primary

Measure	Time frame
Safety and performance: Toxicity (rate of CTC toxicity = grade 3) The primary objective of this study is to demonstrate that the toxicity rate (rate of CTC toxicity = grade 3) under helium ion irradiation, pHe, is less than 10% (and thus comparable to the toxicity rate under proton or heavy ion therapy, pPr/C). The null hypothesis of the study is therefore that the toxicity rate is greater than or equal to 10%, i.e., H0 : pHe = 10%. The follow-up period is 90 days.	—

Measure

Time frame

Safety and performance: Toxicity (rate of CTC toxicity = grade 3) The primary objective of this study is to demonstrate that the toxicity rate (rate of CTC toxicity = grade 3) under helium ion irradiation, pHe, is less than 10% (and thus comparable to the toxicity rate under proton or heavy ion therapy, pPr/C). The null hypothesis of the study is therefore that the toxicity rate is greater than or equal to 10%, i.e., H0 : pHe = 10%. The follow-up period is 90 days.

—

Secondary

Measure	Time frame
Patient-reported outcome (PRO) quality of life progression-free survival	—

Countries

Germany

Contacts

Public ContactJürgen Debus

Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie

Juergen.Debus@med.uni-heidelberg.de+49 (0)6221 56 -34091

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026