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

Primary Purpose

Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV, Laryngeal Squamous Cell Carcinoma Stage III

Status

Terminated

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

Standard care of parenteral nutrition

Parenteral over night nutrition

Cetuximab

Cisplatin

Radiotherapy

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Hypopharynx Stage III focused on measuring Squamous Cell Carcinoma, Head and neck, SCCHN, Parenteral nutrition, Larynx, Hypopharynx, Cavum oris, Radiotherapy, Cetuximab, Cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Landeskrankenhaus Feldkirch
Medizinische Universität Graz, HNO Universitätsklinik
Klinikum Klagenfurt am Wörthersee, HNO-Abteilung
Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie
Hanuschkrankenhaus
Landesklinikum Wiener Neustadt
Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A - Standard of care

Arm B - Parenteral over night nutrition

Arm Description

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

Outcomes

Primary Outcome Measures

Loss of body weight by more than 5% at the end of radiotherapy

Weekly body weight assessments - standardized method for all study sites

Secondary Outcome Measures

Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation

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

Full Information

NCT ID

NCT02236936

First Posted

September 5, 2014

Last Updated

April 30, 2020

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Medical University of Graz

1. Study Identification

Unique Protocol Identification Number

NCT02236936

Brief Title

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

Acronym

AGMT_HNO_PN

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Terminated

Why Stopped

Study stopped due to low recruitment

Study Start Date

February 3, 2017 (Actual)

Primary Completion Date

July 10, 2019 (Actual)

Study Completion Date

July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx 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, Squamous Cell Carcinoma of the Oral Cavity Stage III, Squamous Cell Carcinoma of the Oral Cavity Stage IV, Locally Advanced Malignant Neoplasm

Keywords

Squamous Cell Carcinoma, Head and neck, SCCHN, Parenteral nutrition, Larynx, Hypopharynx, Cavum oris, Radiotherapy, Cetuximab, Cisplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A - Standard of care

Arm Type

Active Comparator

Arm Description

Arm Title

Arm B - Parenteral over night nutrition

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Standard care of parenteral nutrition

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Parenteral over night nutrition

Other Intervention Name(s)

Emulsion for infusion

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

Weekly during radiotherapy; not given if cisplatin is given during radiotherapy Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Cisplatinum, CDDP

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

RTX

Intervention Description

70 Gy / 5 fractions per week, over 7 weeks

Primary Outcome Measure Information:

Title

Loss of body weight by more than 5% at the end of radiotherapy

Description

Weekly body weight assessments - standardized method for all study sites

Time Frame

Difference between baseline and week 8 (after end of RTX)

Secondary Outcome Measure Information:

Title

Bioelectrical Impedance Analysis (BIA): reduction of phase angle by > 10% during treatment/observation

Description

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

Time Frame

Prior to and 1 year after start of RTX, within 7 days and 3 months after end of RTX

Other Pre-specified Outcome Measures:

Title

Assessment of physical strength

Description

Handgrip strength measurement, mean value of three consecutive measurements

Time Frame

Prior to RTX, weekly during RTX, within 1 week and 3 months after end of RTX

Title

Number of implanted PEG tubes

Description

The number of implanted PEG tubes will be recorded

Time Frame

From start of RTX until 3 months after end of RTX

Title

Acute toxicity during radiotherapy

Description

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

Time Frame

During 7 weeks of radiotherapy, at end of radiotherapy and 3 months after radiotherapy

Title

Chronic toxicity after treatment

Description

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

Time Frame

3 months after end of radiotherapy

Title

Dose and dose intensity of radiotherapy

Description

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

Time Frame

At start and end of radiotherapy (duration of radiotherapy 7 weeks)

Title

Progression-free (PFS)

Description

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.

Time Frame

From start until 3 months after end of RTX

Title

Overall survival (OS)

Description

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.

Time Frame

From start until 3 months after end of RTX

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix Keil, Prof.Dr.

Organizational Affiliation

Hanuschkrankenhaus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Landeskrankenhaus Feldkirch

City

Feldkirch

ZIP/Postal Code

A-6807

Country

Austria

Facility Name

Medizinische Universität Graz, HNO Universitätsklinik

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Klinikum Klagenfurt am Wörthersee, HNO-Abteilung

City

Klagenfurt am Wörthersee

ZIP/Postal Code

A-9020

Country

Austria

Facility Name

Ordensklinikum Linz - Barmherzigen Schwestern, Abteilung f. HNO, Kopf- und Halschirurgie

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Hanuschkrankenhaus

City

Vienna

ZIP/Postal Code

1140

Country

Austria

Facility Name

Landesklinikum Wiener Neustadt

City

Wiener Neustadt

ZIP/Postal Code

2700

Country

Austria

Facility Name

Krankenhaus Hietzing, Sonderabteilung f. Strahlentheapie

City

Wien

ZIP/Postal Code

1130

Country

Austria

12. IPD Sharing Statement

Links:

URL

http://www.agmt.at

Description

Sponsor

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

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