TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors (TPF-C-HIT)

This study has been terminated.
(slow recruitment (only 8 patients recruited and treated until 12/2012))
Sponsor:
Collaborator:
University Hospital Heidelberg
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01245985
First received: November 22, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer
Radiation: carbon ion boost
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Local-Regional Control (LRC) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year


Secondary Outcome Measures:
  • disease-free survival (DFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • progression-free survival (PFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • overall survival (OS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • acute radiation effects [ Time Frame: 6 weeks post completion of radiotherapy ] [ Designated as safety issue: Yes ]
  • late radiation effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    includes any adverse events attributable to the combined treatment not otherwise specified

  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 8
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Radiation: carbon ion boost
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245985

Locations
Germany
Dept of Radiation Oncology, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
University Hospital Heidelberg
Investigators
Principal Investigator: Marc W Muenter, MD Heidelberg University
  More Information

No publications provided

Responsible Party: PD Dr. Marc Muenter, Dept of Radiation Oncology, University of Heidelberg, Germany
ClinicalTrials.gov Identifier: NCT01245985     History of Changes
Other Study ID Numbers: TPF-C-HIT
Study First Received: November 22, 2010
Last Updated: April 23, 2013
Health Authority: Germany: Federal Office for Radiation Protection
Germany: Paul-Ehrlich-Institut

Keywords provided by Heidelberg University:
SCCHN
squamous cell carcinoma of the head and neck
oropharyngeal carcinoma
hypopharyngeal carcinoma
laryngeal carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014