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

Primary Purpose

Locally Advanced Head-and-Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
C12 re-irradiation
Photon re-irradiation
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Head-and-Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Heidelberg, Radiation OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

C12 irradiation

Photon irradiation

Arm Description

Evaluation of Safety and Toxicity of C12 ion reirradiation

Evaluation of Safety and Toxicity of photon re-irradiation

Outcomes

Primary Outcome Measures

safety of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
toxicity of carbon ion re-irradiation
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3

Secondary Outcome Measures

progression-free survival
Local progression-free survival
Overall survival
within 12 month after re-irradiation
Score on EORTC QLQ C30 Quality of life questionaire
EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome
Score on EORTC QLQ H&N35 Quality of life questionaire
QLQ (quality of life questionnaire)-H&N (Head and neck) 35, score 1-6, high score means worse outcome

Full Information

First Posted
November 25, 2019
Last Updated
November 2, 2022
Sponsor
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT04185974
Brief Title
Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
Acronym
CARE
Official Title
Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Head-and-Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C12 irradiation
Arm Type
Experimental
Arm Description
Evaluation of Safety and Toxicity of C12 ion reirradiation
Arm Title
Photon irradiation
Arm Type
Active Comparator
Arm Description
Evaluation of Safety and Toxicity of photon re-irradiation
Intervention Type
Radiation
Intervention Name(s)
C12 re-irradiation
Intervention Description
51 Gy(RBE) or 54 Gy
Intervention Type
Radiation
Intervention Name(s)
Photon re-irradiation
Intervention Description
54 Gy(RBE) or 60 Gy
Primary Outcome Measure Information:
Title
safety of carbon ion re-irradiation
Description
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Time Frame
6 month
Title
toxicity of carbon ion re-irradiation
Description
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Time Frame
6 month
Secondary Outcome Measure Information:
Title
progression-free survival
Description
Local progression-free survival
Time Frame
12 month
Title
Overall survival
Description
within 12 month after re-irradiation
Time Frame
12 month
Title
Score on EORTC QLQ C30 Quality of life questionaire
Description
EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome
Time Frame
within 12 month after re-irradiation
Title
Score on EORTC QLQ H&N35 Quality of life questionaire
Description
QLQ (quality of life questionnaire)-H&N (Head and neck) 35, score 1-6, high score means worse outcome
Time Frame
within 12 month after re-irradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Adeberg, PD
Phone
49 622156
Ext
35754
Email
sebastian.adeberg@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hommertgen Adriane, PhD
Phone
49 622156
Ext
34091
Email
adriane.hommertgen@med.uni-heidelberg.de
Facility Information:
Facility Name
University Hospital of Heidelberg, Radiation Oncology
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jürgen Debus, Prof. Dr.
Phone
+49-6221-56
Ext
8202
Email
juergen.debus@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Adriane Hommertgen
Phone
+49-6221-56
Ext
34091
Email
adriane.hommertgen@med.uni-heidelberg.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32758267
Citation
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.
Results Reference
derived

Learn more about this trial

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

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