Status:
TERMINATED
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck
Lead Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborating Sponsors:
Medical University of Graz
Conditions:
Squamous Cell Carcinoma of the Hypopharynx Stage III
Squamous Cell Carcinoma of the Hypopharynx Stage IV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 trea...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02236936
Start Date
February 3 2017
End Date
July 10 2019
Last Update
May 1 2020
Active Locations (7)
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1
Landeskrankenhaus Feldkirch
Feldkirch, Austria, A-6807
2
Medizinische Universität Graz, HNO Universitätsklinik
Graz, Austria, A-8036
3
Klinikum Klagenfurt am Wörthersee, HNO-Abteilung
Klagenfurt, Austria, A-9020
4
Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie
Linz, Austria, 4010