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

TopROC

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

2018-01-05

2024-05-05

2024-05-05

Active (not recruiting)

Early phase I

280

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, two-arm, open label, multicenter, randomized, controlled comparative effectiveness study.\n\nThe trial is based on an event-driven design: the final analysis will be performed when all events have been observed or the study was terminated at one of the interim analyses.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

2023-05-17