- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236936
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck (AGMT_HNO_PN)
Randomized Phase III Study: Supplemental Parenteral Nutrition for Patients With Locally Advanced Inoperable Tumors of the Head and Neck, Receiving Definitive Radiotherapy With Cetuximab or Cisplatin
Study Overview
Status
Conditions
- Locally Advanced Malignant Neoplasm
- 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
- Laryngeal Squamous Cell Carcinoma Stage III
- Laryngeal Squamous Cell Carcinoma Stage IV
- Oropharyngeal Squamous Cell Carcinoma Stage III
- Oropharyngeal Squamous Cell Carcinoma Stage IV
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Feldkirch, Austria, A-6807
- Landeskrankenhaus Feldkirch
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Graz, Austria, A-8036
- Medizinische Universität Graz, HNO Universitätsklinik
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Klagenfurt am Wörthersee, Austria, A-9020
- Klinikum Klagenfurt am Wörthersee, HNO-Abteilung
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Linz, Austria, 4010
- Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie
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Vienna, Austria, 1140
- Hanuschkrankenhaus
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Wien, Austria, 1130
- Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie
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Wiener Neustadt, Austria, 2700
- Landesklinikum Wiener Neustadt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A - Standard of care
Standard care of parenteral nutrition (with or without parenteral nutrition during radio-chemotherapy or radio-immunotherapy in combination with Cetuximab or Cisplatin. Concomitant radiotherapy and immunotherapy (radio-immunotherapy) with Cetuximab or concomitant radiotherapy and chemotherapy (radio-chemotherapy) with Cisplatin |
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
Other Names:
Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)
Other Names:
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
Other Names:
70 Gy / 5 fractions per week, over 7 weeks
Other Names:
|
Experimental: Arm B - Parenteral over night nutrition
Parenteral over night nutrition with ZentroOLIMEL 5.7% parenteral over night with electrolytes, vitamins (Cernevit®) and micronutrients (Addel Trace® or Nutryelt®) 15 ml/kg body weight/day (weight loss >5% from baseline; parenteral nutrition increased up to 25 ml/kg body weight per day) during radio-chemotherapy or radio-immunotherapy in combination with Cetuximab or Cisplatin. Concomitant radiotherapy and immunotherapy (radio-immunotherapy) with Cetuximab or concomitant radiotherapy and chemotherapy (radio-chemotherapy) with Cisplatin |
Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)
Other Names:
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
Other Names:
70 Gy / 5 fractions per week, over 7 weeks
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loss of body weight by more than 5% at the end of radiotherapy
Time Frame: Difference between baseline and week 8 (after end of RTX)
|
Weekly body weight assessments - standardized method for all study sites
|
Difference between baseline and week 8 (after end of RTX)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation
Time Frame: 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
|
Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of physical strength
Time Frame: 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
|
Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX
|
Number of implanted PEG tubes
Time Frame: From start of RTX until 3 months after end of RTX
|
The number of implanted PEG tubes will be recorded
|
From start of RTX until 3 months after end of RTX
|
Acute toxicity during radiotherapy
Time Frame: During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy
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Acute toxicity according to Common Terminology Criteria for Adverse Events (CTCAE 4.0.)
|
During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy
|
Chronic toxicity after treatment
Time Frame: 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
|
3 months after end of radiotherapy
|
Dose and dose intensity of radiotherapy
Time Frame: 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.
|
At start and end of radiotherapy (duration of radiotherapy 7 weeks)
|
Progression-free (PFS)
Time Frame: 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.
|
From start until 3 months after end of RTX
|
Overall survival (OS)
Time Frame: 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.
|
From start until 3 months after end of RTX
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGMT_HNO_PN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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