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04 February 2012
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| [ Print-friendly version ] |
| Phase I-/II-study of Hyperfractionated-Accelerated Radiation Therapy plus Cetuximab plus Cisplatin chemotherapy in locally advanced inoperable squamous cell cancers of head and neck |
| ISRCTN | ISRCTN47339346 |
| ClinicalTrials.gov identifier | |
| Public title | Phase I-/II-study of Hyperfractionated-Accelerated Radiation Therapy plus Cetuximab plus Cisplatin chemotherapy in locally advanced inoperable squamous cell cancers of head and neck |
| Scientific title | |
| Acronym | HART-CIS-CET |
| Serial number at source | Final 01/15.02.05 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Germany, Netherlands |
| Disease/condition/study domain | Squamous cell carcinoma (SCC) |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 10/06/2005 |
| Anticipated end date | 31/12/2012 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Added 01/06/2009: Phase I: 18, Phase II: 74 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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) |
| Sources of funding | Merck Pharma GmbH Darmstadt (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Kuhnt Thomas |
| Address |
Universitätsklinikum Rostock AöR
Zentrum für Radiologie Klinik und Poliklinik für Strahlentherapie Südring 75 |
| City/town | Rostock |
| Zip/Postcode | 18059 |
| Country | Germany |
| Sponsor | Martin-Luther-University Halle-Wittenberg (Germany) |
| Address |
Medical Faculty
Magdeburger Strasse 27 |
| City/town | Halle/Saale |
| Zip/Postcode | 06120 |
| Country | Germany |
| Sponsor website: | http://www.kks-halle.de |
| Date applied | 13/09/2005 |
| Last edited | 01/06/2009 |
| Date ISRCTN assigned | 22/08/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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