NCT04185974

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
58mo left

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2020Jan 2031

First Submitted

Initial submission to the registry

November 25, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2031

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

9.9 years

First QC Date

November 25, 2019

Last Update Submit

March 21, 2026

Conditions

Locally Advanced Head-and-Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • safety of carbon ion re-irradiation

    the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3

    6 month

  • toxicity of carbon ion re-irradiation

    the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3

    6 month

Secondary Outcomes (4)

  • progression-free survival

    12 month

  • Overall survival

    12 month

  • Score on EORTC QLQ C30 Quality of life questionaire

    within 12 month after re-irradiation

  • Score on EORTC QLQ H&N35 Quality of life questionaire

    within 12 month after re-irradiation

Study Arms (2)

C12 irradiation

EXPERIMENTAL

Evaluation of Safety and Toxicity of C12 ion reirradiation

Radiation: C12 re-irradiation

Photon irradiation

ACTIVE COMPARATOR

Evaluation of Safety and Toxicity of photon re-irradiation

Radiation: Photon re-irradiation

Interventions

C12 re-irradiationRADIATION

51 Gy(RBE) or 54 Gy

C12 irradiation
Photon re-irradiationRADIATION

54 Gy(RBE) or 60 Gy

Photon irradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

RECRUITING

Philips University Marburg

Marburg, 35037, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32758267DERIVED

Central Study Contacts

Held Thomas, PD Dr.

CONTACT

49 622156thomas.held@med.uni-heidelberg.de

Cornelia Jäkel, Dr.

CONTACT

49 622156studienkoordination.rad@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 4, 2019

Study Start

August 25, 2020

Primary Completion (Estimated)

July 30, 2030

Study Completion (Estimated)

January 30, 2031

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)