Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Laryngeal Diseases

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Oral Squamous Cell Carcinoma

Hypopharyngeal Cancer

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Herbal and Botanical

Vitamins

Cetuximab

Cisplatin

Immunomodulating Agents

Trace Elements

Antineoplastic Agents, Immunological

Kava

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

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

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

Standard care of parenteral 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.

Parenteral over night nutrition

Weekly during radiotherapy; not given if cisplatin is given during radiotherapy

Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)

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

70 Gy / 5 fractions per week, over 7 weeks

Radiotherapy

Felix Keil, Prof.Dr.

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).

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 .

Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck

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

Handgrip strength measurement, mean value of three consecutive measurements

The number of implanted PEG tubes will be recorded

Acute toxicity according to Common Terminology Criteria for Adverse Events (CTCAE 4.0.)

Chronic toxicity evaluated according to RTOG (Radiation Therapy Oncology Group)/EORTC (European Organisation for Research and Treatment of Cancer) - Toxicity Criteria

Dose and dose intensity including delay of scheduled therapy and absolute dose of radiotherapy applied.

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.

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.

Weekly body weight assessments - standardized method for all study sites

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

Medical University of Graz

Arbeitsgemeinschaft medikamentoese Tumortherapie

Mouth and Tooth Diseases

Laryngeal Neoplasms

Oropharyngeal Neoplasms

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Respiratory Tract Neoplasms

Pharyngeal Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Laryngeal Cancer

Docetaxel

Fluorouracil

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Active comparator is 5-fluorouracil for first three cycles.

All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).

Experimental: cetuximab for the first three cycles.

750 mg/m² day 1 to 5 during 24 hours of 21-days cycle

5-fluorouracil

weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days

Cetuximab Induction

weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks

Cetuximab Radioimmunotherapy

First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks

Boost irradiation

This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.

It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.

Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN

Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck

Information about acute toxicity (grade, relation to study drug) during study treatment and until 3 months after end of radiotherapy will be collected for each patient using CTCAE 3.0 criteria list.

Information about late toxicity (grade) will be collected after 3 months of radiotherapy and until 60 months after radiotherapy using RTOG/EORTC toxicity criteria.

Kind and number of toxicities will be described according to grade. The highest grade of each patient and toxicity will be analysed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck	NCT02236936	Squamous Cell C... Squamous Cell C... Laryngeal Squam... Laryngeal Squam... Oropharyngeal S... Oropharyngeal S... Squamous Cell C... Squamous Cell C... Locally Advance...	Standard care o... Parenteral over... Cetuximab Cisplatin Radiotherapy	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN	NCT01884259	Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C...	Docetaxel Cisplatin 5-fluorouracil Cetuximab Induc... Cetuximab Radio... Boost irradiati...	18 Years - 75 Years	Arbeitsgemeinschaft medikamentoese Tumortherapie
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck	NCT02236936	Squamous Cell C... Squamous Cell C... Laryngeal Squam... Laryngeal Squam... Oropharyngeal S... Oropharyngeal S... Squamous Cell C... Squamous Cell C... Locally Advance...	Standard care o... Parenteral over... Cetuximab Cisplatin Radiotherapy	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie

Spots Global Cancer Trial Database for squamous cell carcinoma of the oral cavity stage iii