E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced head and neck cancer |
|
E.1.1.1 | Medical condition in easily understood language |
advanced head and neck cancer |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067821 |
E.1.2 | Term | Head and neck cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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)
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the global MDADI score at 6 months after end of treatment. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
medical device (percutaneous endoscopic gastrostomy tube ) |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of trial is declared when all the following criteria have been met: • After last visit of the last subject remaining in the study. • The trial is mature for the analysis of the endpoints as defined in the protocol, if the trial reaches its endpoints. • The database has been fully cleaned and frozen for all analyses.
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |