Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer

NCT ID: NCT04185974

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-25
• Study Completion Date: 2024-11-30

Brief Summary

After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity.

In the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity/ safety, local progression-free survival, overall survival and quality-of-life.

Detailed Description

The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year, with male patients affected significantly more often. Common risk factors are smoking, alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain with a significant decrease of the quality-of-life. The prognosis depends on multiple factors such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further risk factors are positive resection margins, extracapsular extension and perineural invasion. While metastatic spread significantly decreases overall survival, the life-limiting problem in patients with head-and-neck cancer is locally invasive and destructive tumor growth leading to a decrease of the performance status and quality of life. After multimodal therapy of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a second primary tumor in the head-and-neck .

Conditions

Locally Advanced Head-and-Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C12 irradiation

Evaluation of Safety and Toxicity of C12 ion reirradiation

Group Type: EXPERIMENTAL

C12 re-irradiation

Intervention Type: RADIATION

51 Gy(RBE) or 54 Gy

Photon irradiation

Evaluation of Safety and Toxicity of photon re-irradiation

Group Type: ACTIVE_COMPARATOR

Photon re-irradiation

Intervention Type: RADIATION

54 Gy(RBE) or 60 Gy

Interventions

C12 re-irradiation

51 Gy(RBE) or 54 Gy

Intervention Type: RADIATION

Photon re-irradiation

54 Gy(RBE) or 60 Gy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Locally recurrent / progressive head-and-neck cancer after initial radiation therapy
• Microscopic or macroscopic tumor after salvage surgery
• Indication for re-irradiation
• Completed wound healing after surgical intervention
• Karnofsky-Performance-Score ≥ 60
• Age ≥ 18 years
• Written informed consent (must be available before enrolment in the trial)
• Ability of subject to understand character and individual consequences of the trial
• For women with childbearing potential, (and men) adequate contraception
• Submission of previous radiotherapy records

Exclusion Criteria

• Re-irradiation of malignancy in the larynx
• Diagnosed plasmocytoma, sarcoma or chordoma
• Previous re-irradiation in-field
• Time interval < 6 months after initial radiotherapy
• Distant metastases (except pulmonary metastases)
• Patients who have not recovered from acute toxicities of prior therapies
• Refusal of the patients to take part in the study
• Pregnant or lactating women
• Known carcinoma <5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
• Participation in another clinical study or observation period of competing trials, respectively

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Juergen Debus

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sebastian Adeberg, PD

Role: CONTACT

sebastian.adeberg@med.uni-heidelberg.de

49 622156 ext. 35754

Hommertgen Adriane, PhD

Role: CONTACT

adriane.hommertgen@med.uni-heidelberg.de

49 622156 ext. 34091

Facility Contacts

Jürgen Debus, Prof. Dr.

Role: primary

juergen.debus@med.uni-heidelberg.de

+49-6221-56 ext. 8202

Adriane Hommertgen

Role: backup

adriane.hommertgen@med.uni-heidelberg.de

+49-6221-56 ext. 34091

References

Held T, Lang K, Regnery S, Weusthof K, Hommertgen A, Jakel C, Tonndorf-Martini E, Krisam J, Plinkert P, Zaoui K, Freudlsperger C, Moratin J, Krauss J, Harrabi SB, Herfarth K, Debus J, Adeberg S. Carbon ion reirradiation compared to intensity-modulated re-radiotherapy for recurrent head and neck cancer (CARE): a randomized controlled trial. Radiat Oncol. 2020 Aug 5;15(1):190. doi: 10.1186/s13014-020-01625-0.

Reference Type: DERIVED

PMID: 32758267 (View on PubMed)

Other Identifiers

RADONK-CARE-2018

Identifier Type: -

Identifier Source: org_study_id