CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 304 target
Drug / intervention
De-escalation radio(chemo)therapy - Level 1 +2 moreradiation
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Squamous cell carcinoma of the oropharynx after surgical removal with adequate lymph node dissection
  • ✓Indication for adjuvant radiotherapy or radiochemotherapy by interdisciplinary tumor board
  • ✓ECOG performance status 0 or 1
  • ✓Adequate compliance for close follow-up
Key exclusion· 13
  • ✕Cumulative nicotine abuse >30 pack-years (excluded from intervention arms, allowed in observation arms)
  • ✕Radiologically presumed or histologically confirmed distant metastasis
  • ✕R2 resection or macroscopically visible residual tumor after surgery
  • ✕No neck dissection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03396718
NCT03396718N/ARecruitingOn TrackUpdated 9mo ago
Long Recruiting
CompareCT.gov

De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head and Neck Squamous Cell Carcinomas: A Phase I Study to Reduce Late Toxicity

Technische Universität Dresden·interventional·Posted Jan 11, 2018·Updated Sep 22, 2025

In Brief

A clinical study evaluating De-escalation radio(chemo)therapy - Level 1, De-escalation radio(chemo)therapy - Level 2, and 1 other intervention for Head-and-neck Squamous Cell Carcinoma. Currently recruiting, targeting 304 participants across 10 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead-and-neck Squamous Cell Carcinoma
CountriesGermany
CollaboratorsGerman 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

Timeline

N/ARecruiting
2018201920202021202220232024202520262027202820292030203120322033
First PostedJan 11, 2018
Enrollment StartNov 29, 2018
Primary CompletionNov 30, 2029
Study CompletionNov 30, 2032
TodayJul 2, 2026
Enrollment to primary: 11.0 yearsPosted 8.5 years agoPrimary completion in 3.4 years

Interventions

De-escalation radio(chemo)therapy - Level 1radiation

55/ 59,4 Gy (intermediate / high risk group)

De-escalation radio(chemo)therapy - Level 2radiation

48,4/ 55 Gy (intermediate / high risk group)

Standard radio(chemotherapy)radiation

60/ 66 Gy (intermediate / high risk group)