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CARE Studie

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

Zusammenfassung

Die Studie untersucht Kohlenstoff Ion Re-Radiotherapie bei Patienten mit rezidivierenden Kopf-Hals-Tumoren im Vergleich zu einer Intensitätsmodulierten-Radiotherapie (IMRT). Die Studien beinhaltet eine breites translationales Program mit Bestimmung der zirkulierenden Tumor-DNA im longitudinalen Verlauf, als auch die prospektive Auswertung bildgebender MRT Parameter.

Einschlusskriterien

  • 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

Ausschlusskriterien

  • Re-irradiation of malignancy in the larynx
  • Diagnosed plasymocytoma, 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
  • Re-irradiation of malignancy in the larynx