- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01245985
TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors (TPF-C-HIT)
April 23, 2013 updated by: Heidelberg University
Induction Chemotherapy With TPF Followed by Radioimmunotherapy With Cetuximab and Intensity Modulated Radiotherapy (IMRT) Plus Carbon Ion Boost for Locally Advanced Tumors of the Oro-, Hypopharynx and Larynx: TPF-C-HIT
TPF-C-HIT investigates the combination of induction chemotherapy with TPF followed by radioimmunotherapy with cetuximab and IMRT plus carbon ion boost with regard to efficacy and toxicity of the combination regimen.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
TPF-C-HIT is a prospective, monocentric phase II trial efficacy, as measured by control and survival rates, as well as toxicity (acute and late effects) of the combined treatment with TPF-induction followed by radioimmunotherapy with the EGFR-antibody cetuximab and carbon ion boost in locally advanced squamous cell carcinoma of the head and neck (SCCHN).
As long-term local control remains a therapeutic challenge in advanced head and neck cancer, locoregional control was chosen as the primary endpoint.
Secondary endpoints are survival rates (disease-free survival, PFS, OS), acute and late radiation effects as well as adverse events.
For development of prognostic markers, proteomic and genomic analyses are also included in the secondary endpoints.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Heidelberg, Germany, 69120
- Dept of Radiation Oncology, University of Heidelberg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent,
- Age of 18 to 70 years,
- Life expectancy of at least 6 month,
- Ability of subject to understand character and individual consequences of clinical trial,
- Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of oro-, hypopharynx and larynx (T2-4, any N, M0),
- Oral cavity or oro- , hypopharynx or laynx as the primary tumor site,
- At least one uni-measurable lesion according to the RECIST criteria, Karnofsky Performances Status > 70%,
- Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL,
- Adequate liver function: Bilirubin < 1.5 mg/dL, SGOT, SGPT < 3 x ULN, GGT < 5 x ULN,
- Adequate renal function: GFR> 70 ml/min,
- Negative serum/urine Beta-HCG test in women of childbearing potential,
- Women of childbearing potential: willingness to use effective contraceptive method, defined as the concomitant use of either an intrauterine pessary (IUP) or contraceptive pill and in both cases, condoms for the treatment duration and 2 months thereafter. Women of non-childbearing potiential are those who are post-menopausal for at least 1 year or sterilized,
- Men of procreative potential: willingness for effective prevention of procreation, defined as a use of condoms and a use of either an intrauterine pessary (IUP) or a contraceptive pill by his partner for the treatment duration and 2 months thereafter,
- Subject's consent to collect blood and/or tumor tissue samples for proteomics and genomics. If a patient does not consent, no samples for proteomics and genomics will be taken. Nonetheles, he/she may be enroled in the study
Exclusion Criteria:
- Previous systemic chemotherapy, radiotherapy or surgery for carcinoma of the head, neck and larynx,
- Nasopharyngeal Carcinoma,
- Prior exposure to EGFR pathway targeting therapy,
- Evidence of distant metastases.
- Other serious illness or medical conditions:
- Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4,
- Significant neurologic or psychiatric disorders including dementia or seizures,
- Active disseminated intravascular coagulation,
- Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study,
- Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher,
- ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumor mass,
- Participation in other interventional trial within the last 30 days§§,
- Surgery within the last 30 days,
- Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment,
- Women: pregnant or breast-feeding,
- Known drug abuse,
- Other previous malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix,
- Legal incapacity or limited legal capacity,
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: treatment arm
patients receive induction chemotherapy with TPF for a maximum of 3 cycles followed by radioimmunotherapy with cetuximab as intensity-modulated radiotherapy (IMRT) plus carbon ion boost
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patients receive induction chemotherapy with TPF for a maximum of 3 cycles followed by radioimmunotherapy with cetuximab as intensity-modulated radiotherapy (IMRT) plus carbon ion boost
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local-Regional Control (LRC)
Time Frame: 12 months
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The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival (PFS)
Time Frame: 12 months
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12 months
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overall survival (OS)
Time Frame: 12 months
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12 months
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disease-free survival (DFS)
Time Frame: 12 months
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12 months
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acute radiation effects
Time Frame: 6 weeks post completion of radiotherapy
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6 weeks post completion of radiotherapy
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late radiation effects
Time Frame: 12 months
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12 months
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adverse events
Time Frame: 12 months
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includes any adverse events attributable to the combined treatment not otherwise specified
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12 months
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proteomic and genomic analyses
Time Frame: 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy
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proteomic and genomic analyses designed to investigate changes during therapy, therefore analyses are carried out at 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy
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6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc W Muenter, MD, Heidelberg University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (ACTUAL)
November 1, 2012
Study Completion (ANTICIPATED)
November 1, 2013
Study Registration Dates
First Submitted
November 22, 2010
First Submitted That Met QC Criteria
November 22, 2010
First Posted (ESTIMATE)
November 23, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 24, 2013
Last Update Submitted That Met QC Criteria
April 23, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Otorhinolaryngologic Diseases
- Neoplasms, Squamous Cell
- Laryngeal Diseases
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Laryngeal Neoplasms
Other Study ID Numbers
- TPF-C-HIT
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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