Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Final 01/15.02.05
Study information
Scientific title
Acronym
HART-CIS-CET
Study hypothesis
An improvement of loco-regional disease control by addition of cetuximab (CET) to hyperfractionated-accelerated radiation therapy (HART) and cisplatin (CIS) is expected.
As of 01/06/2009 this record has been updated. All updates can be found in the relevant fields under the above update date. At this time, the anticipated end date of this trial was extended from 31/12/2007 to 31/12/2012, and the initial target number of participants was 67.
Ethics approval
Ethics commission of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg gave approval on the 10th June 2005.
Study design
Open-label, non-randomised phase I/II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Squamous cell carcinoma (SCC)
Intervention
Phase I:
1. HART: 30/2 Gy once daily, then twice daily 1/4 Gy to a total dose of 70/6 Gy
2. Chemotherapy: cisplatin - escalating doses (20, 30, 35, 40 mg/sqm), once weekly (typically on Monday), week one to six intravenous (iv) over a one hour infusion on days 1, 8, 15, 22, 29, 36
3. Antibody: cetuximab - loading dose 400 mg/sqm iv over a 120-min infusion on day 7 followed by subsequent weekly doses of 250 mg/sqm weeks one to six iv over a one hour infusion on days 1, 8, 15, 22, 29, 36
Phase II:
1. HART: see phase I
2. Chemotherapy: cisplatin at the recommended dose level defined in phase I
3. Antibody: see phase I
Intervention type
Drug
Phase
Phase I/II
Drug names
Cetuximab, cisplatin
Primary outcome measure
Phase I:
Definition of maximum tolerated dose (MTD) of cisplatin in HART-CIS-CET
Phase II:
Determination of the two year progression-free survival (PFS)
Secondary outcome measures
Phase I:
1. Evaluation of toxicity (according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0)
2. Determination of objective tumour response rate (ORR) (according to Response Evaluation Criteria In Solid Tumors [RECIST])
3. Determination of one, two and five year PFS, loco-regional progression-free survival (LPFS) and overall survival (OS)
Phase II:
1. Determination of one and five year-PFS
2. Determination of one, two and five year LPFS and OS
3. Determination of ORR (according to RECIST)
4. Evaluation of toxicity (according to CTCAE version 3.0)
Overall trial start date
10/06/2005
Overall trial end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with histologically confirmed unresectable squamous cell carcinoma (SCC) of the oral cavity (no lip), oropharynx, hypopharynx or larynx (stage III/IVa or b)
2. Unidimensionally measurable lesion
3. Signed informed consent
4. Karnofsky Performance Status more than or equal to 70%
5. Aged between 18 and 70 years
6. Curative treatment intent
7. Negative serum or urine pregnancy test (women of childbearing potential)
8. Adequate bone marrow, hepatic and renal function
All patients should have a dental examination and appropriate, dental therapy if required prior to the beginning of radiotherapy. A percutaneous gastrostomy (PEG) is required.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Added 01/06/2009: Phase I: 18, Phase II: 74
Participant exclusion criteria
1. Unknown primary cancer, nasopharynx cancer or salivary gland cancer
2. Metastatic disease
3. Another cancer within five years of study entry
4. Serious concomitant disease or medical condition
5. Pregnancy or lactation
6. Women of child-bearing potential with unclear contraception
7. Previous treatment with chemotherapy, radiotherapy or surgery in head and neck
8. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening
9. Life expectancy less than three months
10. Contraindications to receive cisplatin or cetuximab
11. Previous exposure to monoclonal antibodies and/or epidermal growth factor receptor (EGFR)-targeted therapy
12. Social situations that limit the compliance with study requirements
Recruitment start date
10/06/2005
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Germany, Netherlands
Trial participating centre
Universitätsklinikum Rostock AöR
Rostock
18059
Germany
Sponsor information
Organisation
Martin-Luther-University Halle-Wittenberg (Germany)
Sponsor details
Medical Faculty
Magdeburger Strasse 27
Halle/Saale
06120
Germany
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Merck Pharma GmbH Darmstadt (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list