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

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether reducing the amount of radiation given after surgery for certain types of head and neck cancer can still effectively control the disease while minimizing side effects. Specifically, it looks at patients with squamous cell carcinoma in areas like the oral cavity and larynx. The trial aims to eliminate radiation to the elective neck area if patients meet certain surgical and cancer treatment standards. This could lead to fewer long-term side effects from radiation therapy, which can significantly impact a patient's quality of life.

To participate in the trial, patients must be at least 18 years old and have a confirmed diagnosis of specific types of squamous cell carcinoma. They should have undergone surgery for their cancer and have no significant spread of the disease. Participants will be required to start radiation therapy at least six weeks after their surgery and must sign a consent form to join the study. Throughout the trial, patients can expect close monitoring and support from the research team, ensuring they understand the process and can follow the study guidelines.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
• • 2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard
• • 3. Indication for postoperative radio(chemo)therapy
• • 4. No lymph node metastases \> 6cm
• • 5. Lymph node metastases in not more than 3 lymph node level
• • 6. No distant metastases (cM0)
• • 7. Age ≥ 18 years, no upper age limit
• • 8. Eastern Cooperative Oncology Group (ECOG) ≤ 2
• • 9. Patients who understood protocol contents and are able to behave according to protocol
• • 10. Signed study-specific consent form prior to therapy
• • 11. 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 Criteria:
• • 1. macroscopic incomplete resection R2
• • 2. Distant metastases (cM1)
• • 3. Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
• • 4. Lymph node metastases in \> 3 lymph node level
• • 5. pregnant or lactating/nursing women
• • 6. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
• • 7. Any condition potentially hampering compliance with the study protocol and follow-up schedule
• • 8. On-treatment participation on other clinical therapeutic trials
• • 9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))
• • 10. Patients who have contraindication for MRI and CT with contrast agent (both)
• • 11. Prior (\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage
• • 12. 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