Clinical trial NCT04185974: Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer
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
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Head-and-Neck Cancer
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: safety of carbon ion re-irradiation
timeFrame: 6 month
measure: toxicity of carbon ion re-irradiation
timeFrame: 6 month
Secondary outcomes:
measure: progression-free survival
timeFrame: 12 month
measure: Overall survival
timeFrame: 12 month
measure: Score on EORTC QLQ C30 Quality of life questionaire
timeFrame: within 12 month after re-irradiation
measure: Score on EORTC QLQ H&N35 Quality of life questionaire
timeFrame: within 12 month after re-irradiation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg, Radiation Oncology
Study officials:
References:
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.