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De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas

Study acronym: DELPHI
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 9 to 10v7
  2. Start date: Sep 4, 2018 to Nov 29, 2018
    • Study description expanded, about 13 words
    • Study sites revised (9)
    v6
  3. Primary completion date: Jan 2026 to Nov 30, 2029
    • Enrollment target: 384 to 304
    • Study sites: 10 to 9
    • Study completion date: Jan 2029 to Nov 30, 2032
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Eligibility criteria expanded, about 24 words
    • Site details revised at 4 of 10 sites
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2018 to Sep 4, 2018
    • Study sites: 9 to 10
    • Collaborators: 3 to 4
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and / or residual tumor (R1-Status) after resection. Oropharyngeal cancer caused by HPV (human papillomavirus 16) is a distinct subgroup with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx). Additionally a superior outcome after R(C)Tx over HPV negative patients was shown for patients treated with primary or adjuvant RCTx. To date it is unknown if the total dose of the radiotherapy can be safely reduced with the aim to decrease the therapy associated late effects. Patients with a HPV associated carcinoma that take part in the study will be treated with a reduced radiotherapy dose, chemotherapy will be prescribed based on clinical factors (number of affected lymph node, presence of extracapsular spread or residual tumor). Radiation dose will be reduced in two steps.
Trial Details
NCT Number NCT03396718
Lead Sponsor Technische Universität Dresden
Collaborators: German Cancer Research Center, National Center for Tumor Diseases (NCT) Dresden, National Center for Tumor Diseases, Heidelberg, Radiation Oncology Working Group of the German Cancer Society
Conditions
(from sponsor)		 Head-and-neck Squamous Cell Carcinoma
Related terms Head and Neck Neoplasms, Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 304 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov