EUCTR2016-002163-34-DE
Active, not recruiting
Phase 1
Comparative Effectiveness Trial of Transoral Head and Neck Surgery followed by adjuvant Radio(chemo)therapy versus primary Radiochemotherapy for Oropharyngeal Cancer (TopROC)
niversity Medical Center Hamburg-Eppendorf0 sites280 target enrollmentJune 14, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Enrollment
- 280
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 %
- •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.
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
Outcomes
Primary Outcomes
Not specified
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