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
- Conditions
- Squamous cell carcinoma (SCC)CancerCarcinoma of the skin
- Registration Number
- ISRCTN47339346
- Lead Sponsor
- Martin-Luther-University Halle-Wittenberg (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 92
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I:<br>Definition of maximum tolerated dose (MTD) of cisplatin in HART-CIS-CET<br><br>Phase II:<br>Determination of the two year progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method Phase I:<br>1. Evaluation of toxicity (according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0)<br>2. Determination of objective tumour response rate (ORR) (according to Response Evaluation Criteria In Solid Tumors [RECIST])<br>3. Determination of one, two and five year PFS, loco-regional progression-free survival (LPFS) and overall survival (OS)<br><br>Phase II:<br>1. Determination of one and five year-PFS<br>2. Determination of one, two and five year LPFS and OS<br>3. Determination of ORR (according to RECIST)<br>4. Evaluation of toxicity (according to CTCAE version 3.0)