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

Korábbi kezelés

• macroscopic incomplete resection R2
• Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
• Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))
• 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

Más betegség

• Any condition potentially hampering compliance with the study protocol and follow-up schedule

Egyéb

• Distant metastases (cM1)
• 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
• On-treatment participation on other clinical therapeutic trials
• Patients who have contraindication for MRI and CT with contrast agent (both)

• 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)