RecruitingPhase 2Phase 3NCT06030440
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
508 participants
Start Date
Jan 26, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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)
Exclusion Criteria12
- 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
Interventions
RADIATIONEliminating RT to the elective neck
Reduction of radiation volume by eliminating radiotherapy to the elective neck
RADIATIONRT standard of care
postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06030440
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