Clinical trial · Interventional
Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC
Assessing Tumor Response and IMRT Treatment Planning After Induction Chemotherapy Based on FDG-PET/CT for Locally Advanced Head and Neck Squamous Cell Carcinoma.
NCT02047201CI-TRIAL-00021199completedPhase 2ClinicalTrials.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)
To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck squamous cell carcinoma.
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 Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
| PET/CT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Induction chemotherapy (Docetaxel, Cisplatin and Fluorouracil) following radiochemotherapy (IMRT using PET/CT images after IC for treatment planning + cisplatin iv 40 mg/m2 weekly).
- interventionNames
- Radiation: IMRT
- Radiation: PET/CT
- Drug: Docetaxel
- Drug: Fluorouracil
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 24 months after treatment
- description
- PFS was defined as the time from the first day of IC first cycles to either progression or death.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients aged 18 years or over; * Histologically confirmed locally advanced (stage III and IV) head and neck squamous cell carcinoma (HNSCC); * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; * Signed written informed consent approved by the Lithuanian Bioethics Committee (LBEC); Exclusion Criteria: * Positive serum pregnancy test in women of childbearing potential or breastfeeding; * Presence of distant metastasis; * Second primary tumor; * History of other malignancy within the last 5 years; * Recurrent head and neck cancer; * Serious uncontrolled concomitant disease that would contraindicate the use of any drugs use in this study as chemotherapy or radiotherapy; ; * Inadequate organ function, evidenced by the following laboratory results: 1. Absolute neutrophil count \<1,500 cells/mm3; 2. Platelet count \<100,000 cells/mm3; 3. Hemoglobin \<9 g/dL; 4. Total bilirubin greater than the upper limit of normal (ULN); 5. AST (SGOT) or ALT (SGPT) \>1,5 x ULN; 6. Alkaline phosphatase levels \>2,5 x the ULN; 7. Serum creatinine \>2,0 mg/dl or 177 umol/l.
References
Publications (0)
Data not yet available
No reference posted for this study.