Carbon ion re-radiotherapy for recurrent head-and-neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of carbon ion re-radiotherapy (reCIRT) compared to conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer. The study focuses on assessing safety, local progression-free survival, overall survival, and quality of life in a cohort that has limited treatment options after initial therapies. Participants must have experienced local recurrence or progression after prior radiation therapy and meet specific eligibility criteria. The trial aims to provide insights into the potential benefits of reCIRT in managing this challenging patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital of Heidelberg, Radiation Oncology
  Heidelberg, Germany Recruiting
• Philips University Marburg
  Marburg, Germany Recruiting

Study contacts

• Study coordinator: Held Thomas, PD Dr.
• Email: thomas.held@med.uni-heidelberg.de
• Phone: 49 622156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.