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
About this trial
This is an interventional treatment trial for Locally Advanced Head-and-Neck Cancer
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
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
NCT ID
NCT04185974
First Posted
November 25, 2019
Last Updated
November 2, 2022
Sponsor
University Hospital Heidelberg
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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