RecruitingNot ApplicableNCT04185974

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

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


Sponsor

University Hospital Heidelberg

Enrollment

72 participants

Start Date

Aug 25, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing carbon ion re-irradiation — a specialized, highly targeted form of radiation — for patients with head and neck cancer that has come back after initial radiation therapy. Carbon ions can deliver high doses more precisely than conventional radiation, which may help when re-treating previously irradiated areas. **You may be eligible if...** - You have head and neck cancer that has returned or progressed after prior radiation - You have had surgery to remove as much tumor as possible (with some microscopic or visible cancer remaining) - You are in reasonable health (Karnofsky performance score 60 or above) - You are 18 or older and can give written consent **You may NOT be eligible if...** - You have not had a prior course of radiation to the head/neck (this trial is specifically for re-irradiation) - You have distant metastases (cancer that has spread to other organs) - You have not yet healed from surgery - You have severe neurological or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONC12 re-irradiation

51 Gy(RBE) or 54 Gy

RADIATIONPhoton re-irradiation

54 Gy(RBE) or 60 Gy


Locations(2)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, Germany

Philips University Marburg

Marburg, Germany

View Full Details on ClinicalTrials.gov

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NCT04185974


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