Condition category
Cancer
Date applied
13/09/2005
Date assigned
22/08/2006
Last edited
01/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kuhnt Thomas

ORCID ID

Contact details

Universitätsklinikum Rostock AöR
Zentrum für Radiologie
Klinik und Poliklinik für Strahlentherapie
Südring 75
Rostock
18059
Germany

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 measures

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

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

http://www.kks-halle.de

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes