Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal CancerPhase 2TPF-C-HITNCT01245985
TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors
A Phase 2 study testing carbon ion boost in people with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer
- What is being tested?
- carbon ion boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept of Radiation Oncology, University of Heidelberg
Heidelberg, 69120
About this study
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
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.
Read the 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.
- Being tested
- carbon ion boost
- Keywords
- SCCHN, squamous cell carcinoma of the head and neck, oropharyngeal carcinoma, hypopharyngeal carcinoma, laryngeal carcinoma
- Medical subject headings
- Laryngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ion boostRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: carbon ion boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local-Regional Control (LRC)
The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year
Measured: 12 months
Secondary outcomes (7)
disease-free survival (DFS)
Measured: 12 months
progression-free survival (PFS)
Measured: 12 months
overall survival (OS)
Measured: 12 months
acute radiation effects
Measured: 6 weeks post completion of radiotherapy
late radiation effects
Measured: 12 months
adverse events
includes any adverse events attributable to the combined treatment not otherwise specified
Measured: 12 months
proteomic and genomic analyses
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
Measured: 6 measuring points: days 50, 64, 73, 106 of treatment; 6 weeks post completion of radioimmunotherapy; 3 months post completion of radioimmunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2013 (estimated)
Why it stopped: slow recruitment (only 8 patients recruited and treated until 12/2012)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg
- Investigators
- Marc W Muenter, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245985
- Sponsor's protocol ID
- TPF-C-HIT
- Acronym
- TPF-C-HIT
- Status last verified
- Apr 2013
- First submitted
- 22 Nov 2010
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01245985
- Acronym / sponsor ID
- TPF-C-HIT / TPF-C-HIT
- Keywords
- SCCHN, squamous cell carcinoma of the head and neck, oropharyngeal carcinoma, hypopharyngeal carcinoma, laryngeal carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment (only 8 patients recruited and treated until 12/2012)
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (estimated)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Radiation: carbon ion boostpatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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),
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbon ion boostpatients 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 | treatment arm |
Primary outcome
Local-Regional Control (LRC)
Time frame: 12 months
The primary endpoint of the study is the Local-Regional Control (LRC) at 1 year
7 secondary outcomes
disease-free survival (DFS)
Time frame: 12 months
progression-free survival (PFS)
Time frame: 12 months
overall survival (OS)
Time frame: 12 months
acute radiation effects
Time frame: 6 weeks post completion of radiotherapy
late radiation effects
Time frame: 12 months
adverse events
Time frame: 12 months
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
Results and safety
The study was stopped early (reason given: slow recruitment (only 8 patients recruited and treated until 12/2012)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc W Muenter, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carbon ion boost in people with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow recruitment (only 8 patients recruited and treated until 12/2012)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local-Regional Control (LRC) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.