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Trial Title:
Treatment Selection According to Skin Reaction to Cetuximab
NCT ID:
NCT01472653
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Cetuximab
Conditions: Keywords:
Head and neck Cancer
Radiochemotherapy
Radioimmunotherapy
Skin rush
locoregional control
Survival
Toxicity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
cisplatin
Description:
cisplatin 30 mg/m2/week I.V. during radiotherapy
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
3-dimensional conformal radiotherapy planning and delivery, 35x2 Gy/day over 7 weeks
Intervention type:
Drug
Intervention name:
cetuximab
Description:
cetuximab 400 mg/m2 I.V. 1 week before the start of radiotherapy, cetuximab 250 mg2/week
I.V. during radiotherapy
Other name:
Erbitux
Summary:
The therapy of patients with locally advanced head and neck cancer will be adjusted to
the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin,
i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy
(radiotherapy and Cisplatin.
Detailed description:
Background: According to literature, the treatment results in irradiated patients who
develop intensive skin reaction after concomitant Cetuximab administration appear
improved as compared to the results of standard combination of radiotherapy and
Cisplatin. In other patients, no beneficial effect of Cetuximab is expected and the
therapy with Cisplatin (concomitantly with irradiation) is more effective in this group.
In this proposed single-institution non-randomized phase II study on patients with
locally advanced squamous cell carcinoma of the head and neck, the therapy will be
adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab
and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or
radiochemotherapy (radiotherapy and Cisplatin).
Methods: In the patients with inoperable tumors, induction chemotherapy (Docetaxel 75
mg/m2, Cisplatin 75 mg/m2, 5-Fluorouracil 750 mg/m2 in continuous infusion days 1-5;
repeated every 21 days for 4 cycles) will be administered. In the week before the first
fraction of radiotherapy, all patients will receive a loading dose of Cetuximab (400
mg/m2) and combination of Cetuximab (250 mg/m2) and Cisplatin (30 mg/m2) during the first
week of irradiation. After multidisciplinary assessment of the grade of skin rush,
conducted at the end of the second week of irradiation, the patients will be grouped as
follows: arm A - skin rush of CTCAE v3.0 grade <2 will proceed with radiochemotherapy
with Cisplatin; arm B - skin rush of CTCAE v3.0 grade >=2 will proceed with
radioimmunotherapy with Cetuximab.
The planned number of patients included in the study is 120 (arm A - 50, arm B - 70) and
recruitment period is 3 years. The primary objective of the study is to determine
radiologically the complete response rate 12-14 weeks after therapy. The secondary
objectives are locoregional control, progression-free survival and overall survival at 2
years after therapy, acute and late toxicity.
Expected results: The expected complete response rate in patients treated with
radiochemotherapy and those treated with radioimmunotherapy is 50% and 75%, respectively.
We also expect the difference in an absolute survival gain between the groups to be 25%.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Squamous cell carcinoma, histologically proven (with HPV-status determined in
patients with oropharyngeal primary)
- Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
- Locally and/or regionally operable and inoperable tumors (UICC TNM stages III, IVa
or IVb), without distant metastases (M0-stage)
- Male or female ≥18 years of age
- Expected survival >6 months
- WHO performance status 0-2
- Laboratory parameters:
hemoglobin ≥100 g/L; leukocyte count > 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L;
platelet count > 100x109/L; total bilirubin < 1.25x upper normal limit; transaminases
(ALT, AST) < 5x upper normal limit; creatinine clearance (ECC) ≥ 60 ml/minute;
- Presence of at least one bidimensionally measurable index lesion
- Effective contraception for both male and female subjects if risk of conception
exists
- Signed written informed consent
Exclusion Criteria:
- Other previous malignancy within 5 years, with exception of a history of a
previously adequately treated basal cell carcinoma of the skin or pre- invasive
carcinoma of the cervix
- Chemotherapy ineligibility:
unstable cardiopulmonary, renal and liver disease likely to compromise the safe delivery
of I.V. infusion (chemotherapy); haematologic diseases; clinically evident hearing
impairment; pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE
v3.0; previous administration of Cetuximab or Cisplatin;
- Active, uncontrolled infection
- Medical or psychological condition which in the opinion of the investigator
precludes the safe administration of the planned radiotherapy or systemic therapy
- Known drug abuse or severe alcohol abuse
- Pregnancy or breast feeding
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Oncology Ljubljana
Address:
City:
Ljubljana
Zip:
SI-1000
Country:
Slovenia
Status:
Recruiting
Contact:
Last name:
Primož Strojan, Prof.
Email:
pstrojan@onko-i.si
Investigator:
Last name:
Marta Dremelj, MD, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Igor Fajdiga, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Cvetka Kuhar Grašič, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jančar Boris, MD, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Simona Jereb, MD
Email:
Sub-Investigator
Investigator:
Last name:
Katarina Karner, MD, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Barbara Žumer, MD
Email:
Sub-Investigator
Start date:
December 2011
Completion date:
December 2016
Lead sponsor:
Agency:
Institute of Oncology Ljubljana
Agency class:
Other
Source:
Institute of Oncology Ljubljana
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01472653