Clinical trial · Interventional
Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck
Phase II Study of Oxaliplatin in Combination With 5-Fluorouracil (5-FU) in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT00611754CI-TRIAL-00001149completedPhase 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 efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)
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 |
|---|---|---|---|
| Oxaliplatin, 5-FU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer.
Secondary outcomes (1)
- measure
- To investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Patients aged 18-70 years, with inoperable locally advanced or metastatic squamous cell carcinoma of the head and neck (stage III-IV) histologically proven, no prior chemo and/or hormone therapy for metastatic disease or local recurrence (adjuvant or neo-adjuvant chemotherapy or radio-chemotherapy was allowed if finished since more than 6 months before inclusion and cisplatinum total dose used \< or=to 300 mg/m² or carboplatinum total dose used \< or=to 200mg/m²), at least 1 target lesion (measurable in 2 dimensions \> or=to 20 mm on computed tomography (CT) or magnetic resonance imaging (MRI) evaluated \< 15 days before start of study treatment, outside of irradiated fields),performance status (PS) \< or =to 2 World Health Organization (WHO), weight loss \< 5% normal weight,hemoglobin \> or =to 10 g/dL, neutrophils \> or =to 2000/mm3, platelets \> or =to 100,000/mm3 , creatinine \< or =to 1.5 x upper limit of normal (ULN), bilirubin \< or =to .5 x ULN, alanine amino-transferase (ALT)/aspartate amino-transferase (AST)\< or =to 2.5 x ULN (5 x ULN if liver metastases), clotting: prothrombin time (PT) \> or =to 60%. Written informed consent signed by patient and doctor prior to all study procedures - Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.