Clinical trial · Interventional
Low-Dose Weekly vs High-Dose Cisplatin
Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer.
NCT03649048CI-TRIAL-00092908RADIOrecruitingN/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)
This study is a prospective open-label randomized clinical trial. Following informed consent eligible LASCCHN patients (n=100) planned for CRT will be stratified by tumor p16 status and then randomized in a 1:1 fashion to either concurrent HD cisplatin or concurrent weekly LD cisplatin.
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 |
|---|---|---|---|
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy
- interventionNames
- Drug: High-Dose Cisplatin
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapy
- interventionNames
- Drug: Low-Dose Cisplatin
- Radiation: Radiotherapy
Primary outcomes (4)
- measure
- Hearing related quality of life (QOL)
- timeFrame
- 1-year post start of treatment
- description
- Assessed with the Hearing Handicap Inventory for Adults (HHIA) Questionnaires. Scored by a points system. The higher the points the more significant the hearing handicap.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Willing and able to provide written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Histologically or cytologically confirmed squamous cell carcinoma * Primary tumor site includes oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, or larynx and primary unknown * Patients must be deemed suitable for HD cisplatin therapy based on tumor characteristics, clinical condition and comorbidities in the judgement of the treating medical oncologist. * Patients must be planned to receive radical intent radiation treatment based on clinical condition, comorbidities and tumor characteristics in the judgment of the treating radiation oncologist * Adequate organ and marrow function independent of transfusion for at least 7 days prior to randomization defined as: * Hemoglobin \> 80 g/L; Absolute neutrophil count \>1.5x10⁹ /L, platelets \>100x10⁹/L; Bilirubin \< 35 umol/L; AST or ALT \< 3 x the upper limit of normal; Calculated creatinine clearance (as determined by Cockcroft- Gault) \> 50 ml/min Males: Creatinine Clearance = Weight (kg) x (140 - Age) (mL/min) 72 x serum creatinine (mg/dL) Females: Creatinine Clearance = Weight (kg) x (140 - Age) x 0.85 (mL/min) 72 x serum creatinine (mg/dL) * Patient must be assessed at head and neck cancer multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumor board prior to randomization. Exclusion Criteria: * Serious medical comorbidities or other contraindications to radiotherapy and/or chemotherapy. * Prior history of head and neck cancer within 5 years. * Nasopharyngeal primary confirmed or suspected. * Severe hearing loss as determined clinically Pre-existing use of hearing aids. * Peripheral neuropathy .grade 2 (CTCAE v4.02). * Prior or planned neoadjuvant chemotherapy prior to CRT. * Prior head and neck radiation at any time. * Distant metastatic disease. * Inability to attend full course of radiotherapy or follow-up visits. * Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer or in-situ carcinoma. * Unable or unwilling to complete QOL questionnaires. * Pregnant or lactating women. * Unable to use dual method of contraception.
References
Publications (0)
Data not yet available
No reference posted for this study.