Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx
1 other identifier
interventional
10
1 country
2
Brief Summary
Phase I study to assess the feasibility (i.e. early toxicity) of Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable head-and-neck-cancer
Started Nov 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJune 3, 2016
June 1, 2016
1.8 years
January 8, 2015
June 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Acute toxicity
up to 3 months following the completion of radiotherapy
Secondary Outcomes (4)
Primary tumor control probability
at 1 and 2 years
Late toxicity
at 1 and 2 years
Progression-free survival
at 1 and 2 years
Overall survival
at 1 and 2 years
Study Arms (1)
Dose escalation
EXPERIMENTALDose escalation
Interventions
Eligibility Criteria
You may qualify if:
- Patients older than 18 years
- Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay)
- N0, N1, N2a, N2b node (AJCC/UICC 7th edition)
- No distant metastasis
- No contra-indication to concomitant chemotherapy
- World Health Organization (WHO) Performance Status of 0 or 1 or Karnofsky performance status ≥ 80.
- Provision of written informed consent
You may not qualify if:
- Patients with induction chemotherapy will not be eligible
- Previous or concurrent history of cancer, except basal cell skin carcinoma
- Second primary tumor at the time of diagnosis
- Previous treatment with surgery, radiotherapy or chemotherapy for head and neck malignancy
- Any evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or psychological disorder
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Grégoire, MD, PhD
Department of Radiation Oncology, and Center for Molecular Imaging, Radiotherapy and Oncology (MIRO), Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain, St-Luc University Hospital, Brussels, Belgium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2015
First Posted
January 13, 2015
Study Start
November 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
June 3, 2016
Record last verified: 2016-06