Brief Title
Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy
Official Title
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
Brief Summary
The ACCEPT (A(denoid) c(ystic) c(arcinoma), E(rbitux, and) p(article) t(herapy))-trial is a
prospective, monocentric phase I/II feasibility trial evaluating toxicity and efficacy in the
combined treatment of intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost
with the epidermal growth factor receptor (EGFR) antibody cetuximab. The primary objective of
the study is to explore the toxicity of the combined modality regimen consisting of heavy ion
therapy / IMRT and EGFR antibody immunotherapy, by assessing the rate of patients with
mucositis or any other toxicity of severity grade 3 or 4 according to NCI CTCAE V. 4.
Secondary endpoints include local control, distant control, overall disease-free survival,
overall survival
Detailed Description
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants with acute adverse effects as a Measure of toxicity
Secondary Outcome
local relapse-free survival
Condition
Adenoid Cystic Carcinoma
Intervention
Cetuximab
Study Arms / Comparison Groups
Cetuximab arm
Description: patients receive weekly cetuximab in combination with IMRT and carbon ion boost
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
49
Start Date
June 2012
Completion Date
July 2017
Primary Completion Date
July 2015
Eligibility 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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Jürgen Debus, Prof. Dr. Dr., +49-6221-56-, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01192087
Organization ID
ACCEPT
Study Sponsor
Heidelberg University
Collaborators
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
Study Sponsor
Jürgen Debus, Prof. Dr. Dr., Principal Investigator, Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
Verification Date
April 2013