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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 : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Tracking Information
First Submitted Date  ICMJE November 25, 2019
First Posted Date  ICMJE December 4, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE August 25, 2020
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • safety of carbon ion re-irradiation [ Time Frame: 6 month ]
    the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
  • toxicity of carbon ion re-irradiation [ Time Frame: 6 month ]
    the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • progression-free survival [ Time Frame: 12 month ]
    Local progression-free survival
  • Overall survival [ Time Frame: 12 month ]
    within 12 month after re-irradiation
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • progression-free survival [ Time Frame: 12 month ]
    Local progression-free survival
  • Overall survival [ Time Frame: 12 month ]
    within 12 month after re-irradiation
  • Quality of life [ Time Frame: 12 month ]
    within 12 month after re-irradiation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
Official Title  ICMJE 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
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced Head-and-Neck Cancer
Intervention  ICMJE
  • Radiation: C12 re-irradiation
    51 Gy(RBE) or 54 Gy
  • Radiation: Photon re-irradiation
    54 Gy(RBE) or 60 Gy
Study Arms  ICMJE
  • Experimental: C12 irradiation
    Evaluation of Safety and Toxicity of C12 ion reirradiation
    Intervention: Radiation: C12 re-irradiation
  • Active Comparator: Photon irradiation
    Evaluation of Safety and Toxicity of photon re-irradiation
    Intervention: Radiation: Photon re-irradiation
Publications * Held T, Lang K, Regnery S, Weusthof K, Hommertgen A, Jäkel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2019)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2024
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04185974
Other Study ID Numbers  ICMJE RADONK-CARE-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Juergen Debus, University Hospital Heidelberg
Study Sponsor  ICMJE University Hospital Heidelberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital Heidelberg
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP