De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

NCT06030440 | Recruiting Phase 2 DMC

• 1 other identifier: DIREKHT2
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.

Conditions

Squamous Cell Carcinoma of the Hypopharynx; Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma of the Oral Cavity; Squamous Cell Carcinoma of the Larynx

Outcome Measures

Primary Outcomes (2)

• Phase II: 1-year PEG feeding tube dependence rate

  observe change of PEG-dependence due to different target volumes

  PEG-dependent 1 year after radiotherapy

• Phase III: Time to local relapse

  difference between the date of randomization and the date of observation of local relapse (LR), or the date of last observation if no LR occurred (censored observation)

  From the date of randomization until the date of observation of local relapse or the date of last observation if no LR occurred, whichever came first (assessed up to 26 months)

Secondary Outcomes (6)

• Disease-free survival

  up to 26 months

• Distant-metastasis-free survival

  through study completion, an average of 26 months

• Overall survival (OS)

  up to 26 months

• Cause of death (tumor-related, not tumor-related)

  through study completion, an average of 26 months

• Acute toxicity according to Common Terminology Criteria (CTC) version 5.0

  up to 2 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation

Radiation: RT standard of care

Investigational Arm

EXPERIMENTAL

postoperative radiotherapy of the head and neck region without elective nodal irradiation

Radiation: Eliminating RT to the elective neck

Interventions

Eliminating RT to the elective neck RADIATION

Reduction of radiation volume by eliminating radiotherapy to the elective neck

Investigational Arm

RT standard of care RADIATION

postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
• Surgery of primary tumor and neck dissection performed according to predefined surgical standard
• Indication for postoperative radio(chemo)therapy
• No lymph node metastases \> 6cm
• Lymph node metastases in not more than 3 lymph node level
• No distant metastases (cM0)
• Age ≥ 18 years, no upper age limit
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Patients who understood protocol contents and are able to behave according to protocol
• Signed study-specific consent form prior to therapy
• Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)

You may not qualify if:

• macroscopic incomplete resection R2
• Distant metastases (cM1)
• Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
• Lymph node metastases in \> 3 lymph node level
• pregnant or lactating/nursing women
• fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
• Any condition potentially hampering compliance with the study protocol and follow-up schedule
• On-treatment participation on other clinical therapeutic trials
• Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))
• Patients who have contraindication for MRI and CT with contrast agent (both)
• Prior (\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage
• History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Sarina Müller, PD

  Universitätsklinikum Erlangen, HNO

  STUDY DIRECTOR

• Rainer Fietkau, Prof

  Universitätsklinikum Erlangen, Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlen Haderlein, PD

CONTACT

+49913185; marlen.haderlein@uk-erlangen.de

Studiensekretariat

CONTACT

+49913185; studiensekretariat.ST@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 11, 2023
• Study Start: January 26, 2024
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): September 1, 2033
• Last Updated: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)