Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation

NCT04214366 | Recruiting Phase 2 DMC

• 1 other identifier: ACCO
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenoid Cystic Carcinoma

Keywords

carbon ion; heavy ion; salivary gland tumor; ACC; Radiation therapy

Outcome Measures

Primary Outcomes (1)

• Freedom from loco-regional progression

  Freedom from loco-regional tumor progression according to MR imaging

  at 5 years

Secondary Outcomes (4)

• Progression-free survival

  at 3 and 5 years

• Overall survival

  at 3 and 5 years

• Acute toxicities

  during and up to 6 weeks after radiotherapy

• Late toxicities

  up to 5 years

Study Arms (2)

Carbon Ion irradiation

EXPERIMENTAL

22 x 3 Gy(RBE) Carbon Ions

Radiation: Carbon ion irradiation

Bimodal Arm

ACTIVE COMPARATOR

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

Radiation: Bimodal irradiation

Interventions

Carbon ion irradiation RADIATION

22 x 3 Gy(RBE) Carbon Ions

Carbon Ion irradiation

Bimodal irradiation RADIATION

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

Bimodal Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

University of Heidelberg, Radiooncology, HIT

Heidelberg, 69120, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 34266402 DERIVED

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Salivary Gland Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Study Officials

• Klaus Herfarth, Prof. Dr.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Herfarth, Prof. Dr.

CONTACT

+49 6221 56 8201; klaus.herfarth@med.uni-heidelberg.de

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. Klaus Herfarth, Vice chair Dept. of Radiation Oncology

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: January 2, 2020
• Study Start: December 1, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

DE (1)