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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer

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Trial Information

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 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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local-Regional Control (LRC)

Outcome Description:

The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Marc W Muenter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg

Authority:

Germany: Federal Office for Radiation Protection

Study ID:

TPF-C-HIT

NCT ID:

NCT01245985

Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer
  • SCCHN
  • squamous cell carcinoma of the head and neck
  • oropharyngeal carcinoma
  • hypopharyngeal carcinoma
  • laryngeal carcinoma
  • Carcinoma
  • Laryngeal Neoplasms
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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