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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002163-34-DE

Enrollment

280

Registered

2017-06-14

Start date

2017-11-28

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

squamous cell carcinoma of the oropharynx MedDRA version: 20.0 Level: LLT Classification code 10026184 Term: Malignant neoplasm of oropharynx System Organ Class: 100000004864

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin Other descriptive name: CISPLATIN Concentration unit: mg milligram(s) Concentration type: range Concentration

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 154

Exclusion criteria

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 dental preservation status or not accomplished wound healing

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effectiveness of primary surgical versus non-surgical treatment of locally advanced, but transorally resectable oropharyngeal cancer in terms of time to local or locoregional failure or death from any cause (LRF) ;Secondary Objective: Effectiveness of primary surgical versus non-surgical treatment of locally advanced, but transorally resectable oropharyngeal cancer with respect to •overall and disease-free survival of both treatments •acute toxicity and late morbidity (including swallowing function) until 3 years after randomization •Quality of life •Cost-effectiveness/ cost-utility analysis ;Primary end point(s): Time to local or locoregional failure (LRF) (defined as time from randomization to local or locoregional failure or death from any cause, whatever occurs first);Timepoint(s) of evaluation of this end point: treatment phase: at every visit according to protocol follow-up: every three months until 36 month, every 6 months until end of study	—

Measure

Time frame

Main Objective: To evaluate the effectiveness of primary surgical versus non-surgical treatment of locally advanced, but transorally resectable oropharyngeal cancer in terms of time to local or locoregional failure or death from any cause (LRF) ;Secondary Objective: Effectiveness of primary surgical versus non-surgical treatment of locally advanced, but transorally resectable oropharyngeal cancer with respect to •overall and disease-free survival of both treatments •acute toxicity and late morbidity (including swallowing function) until 3 years after randomization •Quality of life •Cost-effectiveness/ cost-utility analysis ;Primary end point(s): Time to local or locoregional failure (LRF) (defined as time from randomization to local or locoregional failure or death from any cause, whatever occurs first);Timepoint(s) of evaluation of this end point: treatment phase: at every visit according to protocol follow-up: every three months until 36 month, every 6 months until end of study

—

Secondary

Measure	Time frame
Secondary end point(s): • Overall and disease-free survival • Therapy-associated toxicity including swallowing function • QoL and QALY • Direct and indirect costs ;Timepoint(s) of evaluation of this end point: treatment phase: at every visit according to protocol follow-up: every three months until 36 month, every 6 months until end of study	—

Countries

Germany

Contacts

Public ContactStudy Coordinator

University Medical Center Hamburg-Eppendorf, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde

cj.busch@uke.de00494074105236

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026