Clinical trial · Interventional
3'-Deoxy-3'-[18F] Fluorothymidine and Fludeoxyglucose F 18 PET Scans in Evaluating Response to Cetuximab, Cisplatin, and Radiation Therapy in Patients With Advanced Cancer of the Oropharynx, Larynx, or Hypopharynx
Comparison of FLT and FDG PET in the Evaluation of Response to Cetuximab, Cisplatin and Radiation Therapy in Advanced Head and Neck Malignancies or Response to Standard Chemo-radiotherapy in Esophageal Malignancies
- 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)
RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of the oropharynx, larynx, or hypopharynx.
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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3'-deoxy-3'-[18F]fluorothymidine | Other | — | UNRESOLVED |
| cetuximab | Biological | Cetuximab | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| TdT-mediated dUTP nick end labeling assay | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percent change in the standard uptake value levels calculated for the identified volumes of interest for FLT and FDG PET scans from baseline to after 2 weeks of cetuximab therapy and from baseline to after 20-30 Gy of radiotherapy
Secondary outcomes (1)
- measure
- Quantified change values (after cetuximab therapy and after 20-30 Gy of radiotherapy) for the FLT and FDG PET scan-based topographic profiles created using the ImQuant software package
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx * Advanced disease * Requires chemoradiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 16 weeks * Weight loss ≤ 10% within the past 3 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 3 times ULN * Hemoglobin ≥ 8 g/dL * Creatinine clearance ≥ 40 mL/min * No peripheral neuropathy ≥ grade 2 * No NYHA class III-IV heart disease * No uncontrolled infection * No poorly controlled diabetes that would limit the ability to obtain reliable fludeoxyglucose F 18 PET scan results * No other severe underlying disease that, in the judgment of the investigator, would preclude study participation PRIOR CONCURRENT THERAPY: * More than 2 weeks since prior major surgery and recovered * No prior radiotherapy to the planned treatment field * No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
References
Publications (0)
Data not yet available