Carbon ion re-radiotherapy for recurrent 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
This study is testing if a new type of radiation therapy called carbon ion re-radiotherapy can help people with recurrent head-and-neck cancer live longer and feel better compared to regular radiation treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Heidelberg and 1 other locations) |
| Trial ID | NCT04185974 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with locally recurrent or progressive head-and-neck cancer who have previously undergone radiation therapy and are not candidates for salvage surgery.
Not a fit: Patients with distant metastases, prior re-irradiation in the same field, or those who have not recovered from acute toxicities of previous treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option that minimizes toxicity while improving survival and quality of life for patients with recurrent head-and-neck cancer.
How similar studies have performed: While carbon ion therapy is a relatively novel approach, previous studies have shown promising results in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.