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

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ClinicalTrials.gov Identifier: NCT04185974
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Study Description
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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.


Condition or disease Intervention/treatment Phase
Locally Advanced Head-and-Neck Cancer Radiation: C12 re-irradiation Radiation: Photon re-irradiation Not Applicable

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 .
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: C12 irradiation
Evaluation of Safety and Toxicity of C12 ion reirradiation
 Radiation: C12 re-irradiation
51 Gy(RBE) or 54 Gy
Active Comparator: Photon irradiation
Evaluation of Safety and Toxicity of photon re-irradiation
 Radiation: Photon re-irradiation
54 Gy(RBE) or 60 Gy


Outcome Measures
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Primary Outcome Measures :
  1. safety of carbon ion re-irradiation [ Time Frame: 6 month ]
    the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3

  2. toxicity of carbon ion re-irradiation [ Time Frame: 6 month ]
    the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: 12 month ]
    Local progression-free survival

  2. Overall survival [ Time Frame: 12 month ]
    within 12 month after re-irradiation

  3. Score on EORTC QLQ C30 Quality of life questionaire [ Time Frame: within 12 month after re-irradiation ]
    EORTC (European Organization for Research and. Treatment of Cancer) QLQ (quality of life questionnaire) C30, score 1-6, high score means worse outcome

  4. Score on EORTC QLQ H&N35 Quality of life questionaire [ Time Frame: within 12 month after re-irradiation ]
    QLQ (quality of life questionnaire)-H&N (Head and neck) 35, score 1-6, high score means worse outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185974


Contacts
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Contact: Sebastian Adeberg, PD 49 622156 ext 35754 sebastian.adeberg@med.uni-heidelberg.de
Contact: Hommertgen Adriane, PhD 49 622156 ext 34091 adriane.hommertgen@med.uni-heidelberg.de

Locations
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Germany
University Hospital of Heidelberg, Radiation Oncology Recruiting
Heidelberg, Germany, 69120
Contact: Jürgen Debus, Prof. Dr.    +49-6221-56 ext 8202    juergen.debus@med.uni-heidelberg.de   
Contact: Adriane Hommertgen    +49-6221-56 ext 34091    adriane.hommertgen@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Juergen Debus, Head of department, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04185974    
Other Study ID Numbers: RADONK-CARE-2018
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms