This is a national multicenter study to assess acute radiodermatitis in patients with non-metastatic squamous cell carcinoma of the head and neck (SCCHN) receiving platin-based radiochemotherapy Cancer
Conditions
Interventions
Rate of radiodermatitis grade 3 and 4 in patients receiving topical R1&R2 will be compared to patients receiving standard treatment of the institution by Fisher?s exact text, with 95% confidence inter
Sponsors
Water-Jel Technologies (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed non-metastatic squamous-cell carcinoma of the oral cavity, oro- or hypopharynx and larynx (adjuvant or additive radiochemotherapy post surgery, i.e. R0-, R1- or Rx-resection) or primary definitive treatment concept in patients with LASCCHN UICC stadium III, IVA or IVB) or patients with nasopharyngeal carcinoma 2. Platin-based radiochemotherapy 3. ECOG Performance Status of 0-2 4. More than or equal to 18 years of age 5. Life expectancy of at least 6 months 6. Signed and dated informed consent before the start of specific protocol procedures 7. Women of childbearing potential must have had a negative serum or urine beta-HCG pregnancy test within 7 days prior to the first administration of study treatment or must have a documented condition that prohibits pregnancy (e.g. post-menopausal; hysterectomy) 8. Patients enrolled in this trial must be willing to use effective birth control measures during the course of the trial and the subsequent 2 months
Exclusion criteria
Exclusion criteria: 1. Distant metastases 2. Previous radiotherapy for carcinoma of the head and neck 3. Participation in other clinical trial within 30 days prior to start of study treatment 4. Concomitant treatment with epidermal growth factor (EGFR) targeted therapy. 5. Known hypersensitive reaction to any of the components of study treatments 6. Previous or concurrent cancer within 5 years prior to study entry that is distinct in primary site or histology except adequately treated basal cell carcinoma or pre-invasive cervical carcinoma. 7. Pregnant or breast-feeding patients 8. Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results as judged by the investigator Notes: The applied platin-based chemotherapy in combination with radiotherapy could be Cisplatin or Carboplatin or Cisplatin/5-Fluorouracil or Carboplatin/5-Fluorouracil. The indication for radiochemotherapy could be an adjuvant or an additive or a primary definitive treatment concept. Furthermore, a patient previously treated with induction chemotherapy is allowed to participate in this trial. Previous exposure to epidermal growth factor (EGFR) targeted therapy is allowed. Concomitant treatment with EGFR targeted therapy is an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of rate of acute radiation induced dermatitis (?radiodermatitis?) grade 3/4 during platin-based radiochemotherapy. Severity graded by the National Cancer Institute, Common Terminology Criteria for Adverse Events [CTCAE] Version 4.03 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of radiodermatitis grade 1 and 2 2. Objective Response rate (ORR) 3. Locoregional control (LRC) 4. Progression free survival (PFS) 5. Overall survival (OS) 6. Safety profile of R1 and R2 7. Safety profile of applied radiation protocol 8. Quality of Life (QoL) | — |
Countries
Germany
Outcome results
None listed