Locally Advanced Head-and-Neck Cancer Clinical Trial
— CAREOfficial 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
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Heidelberg, Radiation Oncology | Heidelberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety of carbon ion re-irradiation | the rate of patients with an acute/subacute toxicity CTCAE v5.0 = grade 3 | 6 month | |
Primary | toxicity of carbon ion re-irradiation | the rate of patients with an acute/subacute toxicity CTCAE v5.0 = grade 3 | 6 month | |
Secondary | progression-free survival | Local progression-free survival | 12 month | |
Secondary | Overall survival | within 12 month after re-irradiation | 12 month | |
Secondary | 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 | within 12 month after re-irradiation | |
Secondary | 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 | within 12 month after re-irradiation |