A randomized study of cisplatin plus radiotherapy compared to cetuximab plus radiotherapy in locally advanced head and neck cancer

• Conditions: Stage III and IV head and neck squamous cell cancer (HNSCC) without radiographic signs of distant metastases aimed for radiotherapy with curative intent; MedDRA version: 14.1Level: PTClassification code 10071536Term: Head and neck cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10071537Term: Head and neck cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001879-37-SE
• Lead Sponsor: Department of Oncology, Skåne University Hospital Lund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-19
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 618

Inclusion Criteria

1.The patient must be over 18 years old.
2.Histologically or cytologically confirmed HNSCC of the oropharynx, hypopharynx, larynx or of the oral cavity aimed for unimodal treatment with radiotherapy with curative intent.
3.Tumour stage III and IV according to the UICC TNM classification, but with no evidence of distant metastases beyond the regional nodes in the neck.
4.WHO/ECOG performance status 0-2
5.The patient must be expected to withstand radiotherapy combined with cisplatin or cetuximab.
6.The patient must be able to understand the information about the treatment and give a written informed consent to participate in the trial.
7.Adequate follow-up study must be possible; this will exclude a patient who is uncooperative.
8.Adequate renal function, creatinine clearance > 50 mL/min/1.73 estimated according to local practise at each study centre
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 218

Exclusion Criteria

1.Previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years.

2.Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years.

3.Two or more synchronous primary HNSCC at time of diagnosis

4.Co-existing disease prejudicing survival (expected survival >6 months).

5.Absolute neutrophil count (ANC) < 1.5 x 109/L.

6. Platelet count < 100 x 109/L.

7. Bilirubin > 1.5 times upper limit of normal (ULN)

8. Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) >3 times ULN

9. Pregnancy or lactation

10. Allergy to study drug or to the excipients in their formulation.

11. Peripheral neuropathy > grade 2 according to CTCAE v4.0, grade 2 = moderate symptoms limiting instrumental ADL)

12. Hearing loss / tinnitus is a relative exclusion criteria;

13. Severe cardiac illness

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified