Clinical trial · Observational
Definitive Concurrent Hypofractionated Rth With Weekly Cisplatin in Locally Advanced SCCHN
Definitive Concurrent Hypofractionated Radiotherapy With Weekly Cisplatin in Locally Advanced Squamous Cell Carcinoma Head and Neck (SCCHN)
NCT03880396CI-TRIAL-00059895completedClinicalTrials.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 primary endpoint will be acute toxicity. Secondary endpoints included: late toxicity and quality of life; loco-regional control, disease free survival and overall 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 |
|---|---|---|---|
| Squamous Cell Carcinoma of the Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated Rth with platinol | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- hypofractionated Rth with weekly cisplatin 40mg/m2
- description
- hypofractionated radioyherapy with weekly cisplatin 40mg/m2
- interventionNames
- Radiation: hypofractionated Rth with platinol
Primary outcomes (1)
- measure
- number of patients havingdegrees of Number of patients having acute toxicities of hypofractionated radiotherapy ,Number of patients with locoregional recurrence-free interval
- timeFrame
- 2 years
- description
- degree of acute toxicity (mucosititis degree) according to RECIST criteria,degree of dysphagia ,Number of patients with locoregional recurrence-free interval This is assessed by imaging studies and/or physical exams at follow- up visits. This will include a diagnostic FDG PET/CT scan. CT and/or MRI of the primary site and neck will also be recommended. Patients will be classified as locoregional recurrence-free as long as there is no evidence of locoregional recurrence of disease by clinical evaluation, CT, MRI, and/or PET-CT according to the standard of care. For patients achieving complete response of disease, no further imaging study is necessary.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Have histologically or cytologically proven oropharyngeal, laryngeal or hypopharyngeal squamous cell carcinoma; with AJCC high risk stage II (T2N0, excluding glottic laryngeal) disease, stage III (T1-3N1 or T3N0) and stage IV (T1-4N2 or N3) Locally advanced non metastatic stage II/IV SCCHN according to AJCC stage classification 2018 (8th edition); * Age \>18 years and \<75 years; * No previous treatment(neither chemotherapy nor radiotherapy); * Eastern Cooperative Oncology Group(ECOG) performance status of \<2; * Adequate organ function; * Provide informed oral or written consent. Exclusion Criteria: * prior surgical curative resection for primary tumor; * patients with metastatic disease; * prior radiotherapy within the treatment field; * any relative contraindication to radiotherapy; * prior administration of EGFR monoclonal antibodies, signal transduction inhibitors or targeted therapies; * Active severe infection; * Active concomitant malignancy; * Pregnant and or lactating women; * Pre-existing motor or sensory neurotoxicity \> CTCAE grade 2.
References
Publications (2)
- RESULTThomson DJ, Ho KF, Ashcroft L, Denton K, Betts G, Mais KL, Garcez K, Yap BK, Lee LW, Sykes AJ, Rowbottom CG, Slevin NJ. Dose intensified hypofractionated intensity-modulated radiotherapy with synchronous cetuximab for intermediate stage head and neck squamous cell carcinoma. Acta Oncol. 2015 Jan;54(1):88-98. doi: 10.3109/0284186X.2014.958528. Epub 2014 Oct 3. PMID 25279959
- RESULTSzutkowski Z, Kawecki A, Jarzabski A, Laskus Z, Krajewski R, Michalski W, Kukolowicz P. Hypofractionated accelerated radiotherapy in T1-3 N0 cancer of the larynx: A prospective cohort study with historical controls. Rep Pract Oncol Radiother. 2016 Nov-Dec;21(6):537-543. doi: 10.1016/j.rpor.2016.08.001. Epub 2016 Sep 20. PMID 27698593