Clinical trial · Interventional
Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced SCC of the Oropharynx
Molecular Imaging-based Dose Escalation in HPV Negative Patients With Locally Advanced Squamous Cell Carcinoma of the Oropharynx: a Phase-I Study.
NCT02336711CI-TRIAL-00022471unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dose escalation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Dose escalation
- interventionNames
- Radiation: dose escalation
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- up to 3 months following the completion of radiotherapy
Secondary outcomes (4)
- measure
- Primary tumor control probability
- timeFrame
- at 1 and 2 years
- measure
- Late toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.