TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors

NCT01245985 | Terminated Phase 2 DMC

• 1 other identifier: TPF-C-HIT
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer

Keywords

SCCHN; squamous cell carcinoma of the head and neck; oropharyngeal carcinoma; hypopharyngeal carcinoma; laryngeal carcinoma

Outcome Measures

Primary Outcomes (1)

• Local-Regional Control (LRC)

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

  12 months

Secondary Outcomes (7)

• disease-free survival (DFS)

  12 months

• progression-free survival (PFS)

  12 months

• overall survival (OS)

  12 months

• acute radiation effects

  6 weeks post completion of radiotherapy

• late radiation effects

  12 months

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Interventions

carbon ion boost RADIATION

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

treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Heidelberg University: lead
• University Hospital Heidelberg: collaborator

Study Sites (1)

Dept of Radiation Oncology, University of Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Laryngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pharyngeal Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases

Study Officials

• Marc W Muenter, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

DE (1)