advanced head and neck cancer MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o To assess the Health related QOL (HRQOL) (EORTC QLQ-C30;EORTC QLQ-H&N43 module) and FACT-HN o To assess CCRT related toxicities and PEG tube placement complications o To assess the nutritional status on survival and toxicity outcomes o To assess the clinical tumour response after study treatment o To assess the loco regional control (LRC), distant recurrence/distant progression (DR/DP), second primary (SP), disease-free survival (DFS), disease specific survival (DSS), overall survival (OS). o To assess the impact of HPV and tobacco smoking in oropharyngeal cancer on these secondary endpoints o Cost-Effectiveness of each treatment strategy o Clinical validation of cancer prediction models available at www.predictcancer.org o To assess the dosimetry factors associated with long-term patient-reported outcomes (PRO) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 61
Exclusion criteria
Exclusion criteria: 1) Severe malnutrition 2) Dysphagia requiring a liquid or puree texture modified diet (grade = 2 (CTCAE_v.5) 3) Distant metastasis 4) Serious coagulation disorders (INR>1.5, PTT> 50s, platelets <50000/mm3) 5) Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study. 6) Other malignancies in the 3 years prior to study entry except of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin; 7) Pregnant and/or lactating women. 8) Known hypersensitivity to the study drug (cisplatin) or excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess and compare the subjects reported outcomes measurements in term of swallowing (MD Anderson Dysphagia Inventory (MDADI)) 6 months after end of chemo-radiotherapy treatment in subjects randomized to either the prophylactic PEG tube group or the reactive PEG tube group.;Secondary Objective: oTo assess the Health related QOL (HRQOL) (EORTC QLQ-C30;EORTC QLQ-H&N43 module) and FACT-HN oTo assess CCRT related toxicities and PEG tube placement complications oTo assess the nutritional status on survival and toxicity outcomes oTo assess the clinical tumour response after study treatment oTo assess the loco regional control (LRC), distant recurrence/distant progression (DR/DP), second primary (SP), disease-free survival (DFS), disease specific survival (DSS), overall survival (OS). oTo assess the impact of HPV and tobacco smoking in oropharyngeal cancer on these secondary endpoints oCost-Effectiveness of each treatment strategy oClinical validation of cancer prediction models available at www.predictcancer.org oTo assess the dosimetry factors associated with long-term patient-reported outcomes (PRO) ;Primary end point(s): The primary endpoint is the global MDADI score at 6 months after end of treatment.;Timepoint(s) of evaluation of this end point: end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Patient reported outcomes via self-administered questionnaires: ? HR QOL (EORTC QLQ–C30; EORTC QLQ-H&N43 module and FACT-HN) ? Oral-Oropharyngeal toxicity according to the oral mucositis weekly questionnaire-Head and Neck cancer (OMWQ-NH) completed by the subject. ? Salivary toxicity according to the xerostomia questionnaire completed by the subject. o Incidence, type and severity of all adverse events (AEs) and serious adverse events according to CTCAE version 5.0. Incidence, type and severity of radiotherapy related AEs also according to Radiation Therapy Oncology Group (RTOG) / European Organisation for Research and treatment of Cancer (EORTC) scores [37][38] o Impact of nutritional status on survival and toxicity outcomes by using amongst other, GLIM criteria (Global Leadership Initiative on Malnutrition). o Tumour response after study treatment measured at 3 months by DECT and PET-CT after end of treatment. o Subject outcome: loco regional control (LRC), distant recurrence/distant progression (DR/DP), second primary (SP), disease-free survival (DFS), disease specific survival (DSS), overall survival (OS) o Impact of HPV and tobacco smoking on survival and toxicity outcomes in oropharyngeal cancer subjects. Smoking history and consumption will be assessed at 7 time points: before treatment, at week 3, at 1, 3, 6, 12 and 24 months after the treatment. o Cost-Effectiveness of each treatment strategy o Clinical validation of cancer prediction models available at www.predictcancer.org. HPV-based prognostic nomogram for oro-pharyngeal carcinoma will be analysed 2 years after end of treatment; prediction tool for swallowing dysfunction, xerostomia, sticky saliva and tube feeding dependence will be analysed at 6 months after end of treatment (see Appendix C). o The dosimetry factors associated with long-term PRO at 6 and 12 months after completing treatment. ;Timepoint(s) of evaluation of this end point: end of the study | — |
Countries
Belgium
Contacts
Public ContactCTSU
Institut Jules Bordet
Outcome results
None listed