Laryngeal Squamous Cell Carcinoma Stage III, Laryngeal Squamous Cell Carcinoma Stage IV, Locally Advanced Malignant Neoplasm, Oropharyngeal Squamous Cell Carcinoma Stage III, Oropharyngeal Squamous Cell Carcinoma Stage IV, Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV, Squamous Cell Carcinoma of the Oral Cavity Stage III, Squamous Cell Carcinoma of the Oral Cavity Stage IV
Conditions
Keywords
Squamous Cell Carcinoma, Head and neck, SCCHN, Parenteral nutrition, Larynx, Hypopharynx, Cavum oris, Radiotherapy, Cetuximab, Cisplatin
Brief summary
Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result in higher treatment related toxicity and discontinuation of a potential curative treatment. Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (PN) support in patients with SCCHN treated with curative radiotherapy (RTX) in combination with Cetuximab (E) or Cisplatin (P).
Detailed description
The investigators hypothesize that about 60% of patients receiving RTX without supplemental PN will suffer from critical weight loss of more than 5% during treatment - supplemental overnight PN might result in significant improvement of the nutritional status .
Interventions
DIETARY_SUPPLEMENTStandard care of parenteral nutrition
Standard treatment according to the discretion of the center, any required nutritional support (enteral tube feeding by nasogastric tube or percutaneous endoscopic gastrostomy) when considered necessary is allowed
DIETARY_SUPPLEMENTParenteral over night nutrition
Patients in interventional Arm B will receive parenteral overnight nutrition with ZentroOLIMEL® 5.7% with electrolytes, vitamins (Cernevit®) and micronutrients (Addel Trace® or Nutryelt®) starting with 15 ml/kg body weight/day. In case of weight loss of more than 5%, dose of ZentroOLIMEL® has to be increased up to 25 ml/kg/body weight/day.
BIOLOGICALCetuximab
Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)
DRUGCisplatin
Cisplatin total dose of \>200 mg administered weekly (40 mg/m2/week) or every three weeks (100 mg/m2 every three weeks) according to local standard; not given in combination with cetuximab
RADIATIONRadiotherapy
70 Gy / 5 fractions per week, over 7 weeks
Sponsors
Medical University of Graz
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient who is eligible for definitive curative radio-chemotherapy with Cisplatin or radio-immunotherapy with Cetuximab. * Written informed consent obtained prior to any study specific screening activities and patients have to be able to comply with this protocol. * Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris treated with definitive radiotherapy in combination with Cisplatin or Cetuximab. * p16 status available * Age ≥ 18 * Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception.
Exclusion criteria
* Distant metastases * Prior radiation (Head and neck area) * Pregnant or lactating women * History of other malignancy; yet patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * Concurrent other cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug. * Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent. * Participation in another interventional clinical study at time of study inclusion (except follow-up period without treatment for more than 30 days) or denial of the simultaneous participation in a non-interventional study by the PI of the study center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loss of body weight by more than 5% at the end of radiotherapy | Difference between baseline and week 8 (after end of RTX) | Weekly body weight assessments - standardized method for all study sites |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation | Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX | Determination of parameters on functional nutritional status: fat-free mass (FFM), total body water (TBW), body fat and phase angle will be evaluated by BIA |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity during radiotherapy | During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy | Acute toxicity according to Common Terminology Criteria for Adverse Events (CTCAE 4.0.) |
| Chronic toxicity after treatment | 3 months after end of radiotherapy | Chronic toxicity evaluated according to RTOG (Radiation Therapy Oncology Group)/EORTC (European Organisation for Research and Treatment of Cancer) - Toxicity Criteria |
| Assessment of physical strength | Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX | Handgrip strength measurement, mean value of three consecutive measurements |
| Progression-free (PFS) | From start until 3 months after end of RTX | The study will be finished one year post RTX and clinical al data on PFS will be obtained. In addition, patient will be asked to agree to collection of information regarding PFS even after completion of the trial. |
| Overall survival (OS) | From start until 3 months after end of RTX | The study will be finished one year post RTX and clinical data on OS will be obtained. In addition, patient will be asked to agree to collection of information regarding OS even after completion of the trial. |
| Dose and dose intensity of radiotherapy | At start and end of radiotherapy (duration of radiotherapy 7 weeks) | Dose and dose intensity including delay of scheduled therapy and absolute dose of radiotherapy applied. |
| Number of implanted PEG tubes | From start of RTX until 3 months after end of RTX | The number of implanted PEG tubes will be recorded |
Countries
Austria
Outcome results
None listed