Re-irradiation with proton therapy for head and neck cancer
DAHANCA 37 A Phase II Study of Intensity Modulated Proton Therapy (IMPT) for Re-irradiation With Curative Intent for Recurrent or New Primary Head and Neck Cancer
This study is testing if proton therapy can safely help patients with recurring head and neck cancer who have already had radiation treatment, while also looking at how it affects their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Danish Head and Neck Cancer Group Research network |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT03981068 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of proton radiotherapy for patients with recurrent head and neck neoplasms who have previously undergone radiation treatment. The study aims to assess the safety and efficacy of re-irradiation, focusing on late toxicity, quality of life, loco-regional control, and overall survival. Patients will receive a specific radiation dose regimen alongside standard chemotherapy with cisplatin and nimorazole, as per national guidelines. The trial will evaluate both the clinical outcomes and the patients' quality of life through validated questionnaires.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically verified loco-regional recurrence or new primary head and neck tumors who have previously received radiation therapy.
Not a fit: Patients who have undergone radical surgery with no adverse prognostic pathology or those with distant metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with recurrent head and neck cancers.
How similar studies have performed: Other studies have shown promising results with proton therapy for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological verified loco-regional recurrence or new primary * Available dose plan from primary radiotherapy course * Comparative dose plan with advantages for proton radiotherapy e.g. integral dose * Dmax dose (0.03 cm3) on the cumulated photon dose plan≥90 Gy * Complete Response (CR)\* after initial therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose. * Inoperable or salvage surgery with R1/R2 resection, extranodal extension (ENE) or extensive soft tissue infiltration * Absence of distant metastasis at both * clinical examination AND * PET-CT or CT of thorax and upper abdomen * Life expectancy due to age and co-morbidity of \>=1 year. The general condition must be sufficient to tolerate persistent significant side effects, e.g. tube or cannulae * PS\<=2 (WHO See appendix) Exclusion Criteria: * Radical surgery (R0) and absence of adverse prognostic pathological features * Lymphoma or malignant melanoma * Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic * As of 2019, patients with tracheal cannulas are excluded due to dose uncertainties. This may change if a technical solution becomes available.
Where this trial is running
Aarhus
- Danish Center for Particle Therapy — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Kenneth Jensen — Danish Centre for Particle Therapy
- Study coordinator: Kenneth Jensen, PhD
- Email: kennjens@rm.dk
- Phone: +45 21284108
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.