Spots Global Cancer Trial Database for Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage
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Trial Identification
Brief Title: Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage
Official Title: Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage (DERANO)
Study ID: NCT04252248
Interventions
Study Description
Brief Summary: Open-label, single-center phase I study to evaluate first signs of efficacy and to confirm the safety and tolerability of a decitabine safe-dose treatment in two strata of patients with HPV induced anogenital and head and neck cancers (Stratum 1: patients with high rist for disease recurrence; Stratum 2: patients with failure of standard therapy). The study is expected to enroll 18 patients overall (9 patients in each stratum). The duration of the trial for each patient is expected to be 6 months (two 28 day cycles of study treatment plus four months of additional follow-up). The overall duration of the trial is expected to be approximately 42 months.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UKHD, Klinik für RadioOnkologie und Strahlentherapie, Heidelberg, , Germany
Contact Details
Name: Juergen Debus, Prof. Dr. Dr.
Affiliation: University Hospital Heidelberg
Role: PRINCIPAL_INVESTIGATOR
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