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Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

NCT ID: NCT04214366

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2032-12-01

Brief Summary

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Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.

Detailed Description

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Conditions

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Adenoid Cystic Carcinoma

Keywords

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carbon ion heavy ion salivary gland tumor ACC Radiation therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carbon Ion irradiation

22 x 3 Gy(RBE) Carbon Ions

Group Type EXPERIMENTAL

Carbon ion irradiation

Intervention Type RADIATION

22 x 3 Gy(RBE) Carbon Ions

Bimodal Arm

25 x 2 Gy photon IMRT and 8 x 3 Gy(RBE) Carbon ion boost

Group Type ACTIVE_COMPARATOR

Bimodal irradiation

Intervention Type RADIATION

25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Interventions

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Carbon ion irradiation

22 x 3 Gy(RBE) Carbon Ions

Intervention Type RADIATION

Bimodal irradiation

25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed adenoid cystic carcinoma in the head and neck area
* Indication for irradiation:
* non-operable or
* R1/R2 resected or
* perineural sheat invasion (Pn+) or
* pT3/pT4
* Informed consent
* KI \> 60% or ECOG 0/1 (minimum: self-sufficiency, normal activity or work not possible)
* Age 18-80 years

Exclusion Criteria

* rejection of the study by the patient
* Patient is not able to consent
* Stage IV (distant metastases), except lung metastases \< 1cm
* lymph node involvement (clinical or pathological)
* Previous radiotherapy in the head and neck area
* Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
* Contraindication to MR imaging
* Simultaneous participation in another clinical study that could influence the outcome of this study or the other study
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Klaus Herfarth, MD

Prof. Dr. Klaus Herfarth, Vice chair Dept. of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Herfarth, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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University of Heidelberg, Radiooncology, HIT

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Klaus Herfarth, Prof. Dr.

Role: CONTACT

Phone: +49 6221 56 8201

Email: [email protected]

Facility Contacts

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Klaus Herfarth, Prof. Dr.

Role: primary

References

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Lang K, Adeberg S, Harrabi S, Held T, Kieser M, Debus J, Herfarth K. Adenoid cystic Carcinoma and Carbon ion Only irradiation (ACCO): Study protocol for a prospective, open, randomized, two-armed, phase II study. BMC Cancer. 2021 Jul 15;21(1):812. doi: 10.1186/s12885-021-08473-5.

Reference Type DERIVED
PMID: 34266402 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ACCO

Identifier Type: -

Identifier Source: org_study_id