UnknownNot Applicable

Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx

Belgium10 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients older than 18 years * Patients with squamous cell carcinoma of the oropharynx, HPV-negative (p16 assay) * T size of 3 cm or more in greatest dimension with the exclusion of tumor with bone infiltration * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute toxicity

Timeframe: up to 3 months following the completion of radiotherapy

Trial details

NCT IDNCT02336711

SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

Contact for this trial

Vincent Grégoire, MD, PhD

+ 32-2-7645431 vincent.gregoire@uclouvain.be

View on ClinicalTrials.gov More Head and Neck Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.