Combined Treatment of Adenoid Cystic Carcinoma With Cetuximab and IMRT Plus C12 Heavy Ion Boost - ACCEPT - (ACC, Erbitux, and Particle Therapy); Phase I/II Feasibility Study
18 Years
70 Years
Both
Adenoid Cystic Carcinoma
Trial Information
Combined Treatment of Adenoid Cystic Carcinoma With Cetuximab and IMRT Plus C12 Heavy Ion Boost - ACCEPT - (ACC, Erbitux, and Particle Therapy); Phase I/II Feasibility Study
Treatment with novel radiotherapeutic technologies could increase local control in adenoid
cystic carcinoma of the head and neck. Especially combined treatment with
intensity-modulated radiation therapy and heavy ion (C12) boost to the primary tumor or
previous tumor bed could be established as the treatment of choice in this disease.
Unfortunately, therapeutic results in the treatment of adenoid cystic carcinoma are still
hampered by the occurrence of distant metastases (predominantly in the lungs) which, though
progressing comparatively slowly, still limit the patient's life expectancy. Most adenoid
cystic carcinomas (> 80%) though, exhibit over-expression of EGFR receptors and hence
provide an approach for systemic treatment. In this prospective phase II trial, the
application of the EGFR antibody cetuximab will be evaluated in combination with the
established treatment of intensity-modulated radiation therapy plus C12 heavy ion boost.
The trial aims at evaluation of toxicity and feasibility of the combined treatment, as
primary endpoint, as well as local control and disease-free survival as secondary endpoints.
Inclusion Criteria
Inclusion criteria
- Histologically proven, or surgically resected adenoid-cystic carcinoma of the head
and neck and
- macroscopic or microscopic residual tumor (R1/ R2) or
- Tumor stage >T3/T4 or
- perineural invasion and
- M0 stage
- Written informed consent
- Age between 18 and 70 years
- Karnofsky Index ≥ 70%
- Adequate bone-marrow, liver, and kidney function:
- neutrophils ≥ 1.5 x 109/L,
- thrombocytes ≥ 100 x 109/L,
- haemoglobin ≥ 10.0 g/dL
- bilirubin ≤ 2.0 g/dL
- SGOT, SGPT, AP, gamma-GT ≤ 3 x ULN
- serum creatinine ≤ 1.5 mg/dL
- effective contraception
Exclusion Criteria:
- Prior RT or chemotherapy for tumors of the head and neck
- R0 resection
- M1 (distant metastases)
- prior immunotherapy
- signs of active infection
- other serious illnesses
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or
IV, unstable angina pectoris, history of myocardial infarction within the last twelve
months, significant arrhythmias)
- Significant neurologic or psychiatric disorders including dementia or seizures
- Active disseminated intravascular coagulopathies
- Other serious underlying medical conditions prohibiting the patient's participation
in the trial according to the judgement of the investigators
- Active participation in another clinical trial within the past 30 days
- Known allergic/ hypersensitivity reactions to non-human proteins
- Women: pregnant (Positive serum/ urine beta-HCG ) or breast-feeding,
- Known drug abuse,
- Other previous malignancy within the past 5 years, with exception of a history of a
previous, adequately treated, basal cell carcinoma of the skin or pre-invasive
carcinoma of the cervix,
- Legal incapacity or limited legal capacity,
- Medical or psychological condition which in the opinion of the investigator would not
permit the patient to complete the study or sign meaningful informed consent
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants with acute adverse effects as a Measure of toxicity
Outcome Description:
The primary objective is to explore the toxicity of the combined treatment consisting of heavy ion therapy / IMRT and cetuximab by assessing the rate of patients with mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4. Acute treatment effects will be evaluated 6 weeks and late effects 3 years post completion of treatment
Outcome Time Frame:
6 weeks post completion of therapy
Safety Issue:
Yes
Principal Investigator
Jürgen Debus, Prof. Dr. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
ACCEPT
NCT ID:
NCT01192087
Start Date:
June 2012
Completion Date:
July 2017
Related Keywords:
- Adenoid Cystic Carcinoma
- adenoid cystic carcinoma
- carbon ion therapy
- IMRT (intensity-modulated therapy)
- radioimmunotherapy
- Cetuximab
- Carcinoma
- Carcinoma, Adenoid Cystic
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