Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer

• Status: Active, not recruiting
• Trial end date: 2023-06-05
• Target enrollment: 0
• Participant gender: All

Summary

Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Charite University, Berlin, Germany; University Hospital Ulm; University Medical Center Gießen and Marburg GmbH; University Medical Center Ulm

Criteria

Inclusion Criteria:

• Histologically proven SCC of the oropharynx; T1, N2a-c, M0; T2, N1-2c, M0; T3, N0-2c, M0, with only amendable to transoral resection)

• Primary tumor must be resectable through transoral approach

• p16 immunohistochemitry by local pathology or FFPE tissue must be available for central HPV diagnostic

• Written and signed informed consent

• Briefing through surgeon and radiation oncologist

• ECOG PS ≥2, Karnofsky PS ≥ 60 %

• Age ≥ 18

• Curative treatment intent

• Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 80 x 109/L, hemoglobin > 9.5 g/dL

• Adequate liver function: Bilirubin < 2.0 g/dL, SGOT, SGPT, < 3 x ULN

• If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing.

• dental examination and appropriate dental therapy if needed prior to Confidential TopROC 2017_03_24 Version 1.0 Seite 15 von 124 beginning of radiotherapy

• Nutritional evaluation prior to initiation of therapy and optional prophylactic gastrostomy (PEG) tube placement

Exclusion Criteria:

• Prior invasive malignancy except controlled skin cancer or carcinoma in situ of cervix

• Unknown primary (CUP), nasopharynx, hypopharynx, laryngeal or salivary gland cancer

• Metastatic disease

• Serious co-morbidity, e.g. high-grade carotid artery stenosis, congestive heart failure NYHA grade 3 and 4, liver cirrhosis CHILD C

• Hemoglobin level <9.5g/dl within 4 weeks before randomization

• Pregnancy or lactation

• Women of child-bearing potential with unclear contraception

• Previous treatment with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck

• Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening

• Social situations that limit compliance with study requirements or patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol

• Patients institutionalized by official means or court order

• Deficient