Clinical trial · Interventional
Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer
A Pilot Study to Evaluate Response to Neoadjuvant Chemotherapy With Cisplatin and Docetaxel Followed by Chemoradiation Therapy With Carboplatin in Stage IV Non-metastatic Head and Neck Cancer
NCT00982436CI-TRIAL-00006566unknownPhase 1 / Phase 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)
The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed by carboplatin given at the same time as radiotherapy in the treatment of locally advanced head and neck cancer.
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel/cisplatin | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant/Concomitant Chemoradiation
- description
- Three cycles of docetaxel/carboplatin neoadjuvant chemotherapy followed by chemoradiotherapy for 7 weeks with weekly carboplatin
- interventionNames
- Drug: Docetaxel/cisplatin
- Radiation: Radiotherapy
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer
- timeFrame
- 6 months after initiation of therapy
Secondary outcomes (5)
- measure
- Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx * Measurable or evaluable disease * No distant metastases * Tumor should be surgically unresectable for cure or resection is considered inadvisable * Age \> 18 years * ECOG performance status 0, 1 or 2 * Life expectancy \> 2 months * Patients must have adequate organ and marrow function as defined below: * Leukocytes \> 3,000/mm3 * Absolute neutrophil count \> 1,500/mm3 * Platelets \> 100,000/mm3 * Hemoglobin \> 10.0g/dL * Total Bilirubin \<= institutional upper limit of normal * Aspartate aminotransferase \< 2.5 X institutional upper limit of normal * Alanine aminotransferase \< 2.5 X institutional upper limit of normal * Alkaline phosphatase \< 2.5 X institutional upper limit of normal * Creatinine \<= institutional upper limit of normal OR creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine \> institutional upper limit of normal * Signed informed consent * Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment Exclusion Criteria: * Previous chemotherapy for this malignancy * Previous radiotherapy to head and neck region * Other malignancy within last 5 years except for non-melanoma skin cancer * Uncontrolled intercurrent illness that would prevent delivery of protocol therapy * Peripheral neuropathy \> Grade 2 * Hypercalcemia * Patient is pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.