Back to resultsAdenoid Cystic Carcinoma, Erbitux, and Particle Therapy (ACCEPT)
Primary Purpose
Adenoid Cystic Carcinoma
Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Adenoid Cystic Carcinoma focused on measuring adenoid cystic carcinoma, carbon ion therapy, IMRT (intensity-modulated therapy), radioimmunotherapy, Cetuximab
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
Sites / Locations
- Dept. of Radiation OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cetuximab arm
Arm Description
patients receive weekly cetuximab in combination with IMRT and carbon ion boost
Outcomes
Primary Outcome Measures
Number of Participants with acute adverse effects as a Measure of toxicity
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
Number of Participants with late adverse effects as a Measure of toxicity
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
Secondary Outcome Measures
local relapse-free survival
Local relapse-free survival will be defined as the time from the initial dose of study therapy to the time of locoregional disease progression or relapse or death, or to the date of last assessment without any such event (censored observation)
distant relapse-free survival
Distant relapse-free survival will be defined as the time from the initial dose of study therapy to the time of distant metastasis detection or death, or to the date of last assessment without any such event (censored observation)
overall disease-free survival
Distant disease-free survival will be defined as the time from the initial dose of study therapy to the time of any detection of adenoid cystic carcinoma relapse or development of secondary cancer or death, or to the date of last assessment without any such event (censored observation)
overall survival
The duration of survival will be determined by measuring the time interval from initial dose of study therapy to the date of death of any cause or last observation (censored)
Full Information
NCT ID
NCT01192087
First Posted
August 30, 2010
Last Updated
April 23, 2013
Sponsor
Heidelberg University
Collaborators
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany, University Hospital Heidelberg, Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01192087
Brief Title
Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy
Acronym
ACCEPT
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
Collaborators
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany, University Hospital Heidelberg, Merck KGaA, Darmstadt, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Cystic Carcinoma
Keywords
adenoid cystic carcinoma, carbon ion therapy, IMRT (intensity-modulated therapy), radioimmunotherapy, Cetuximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cetuximab arm
Arm Type
Experimental
Arm Description
patients receive weekly cetuximab in combination with IMRT and carbon ion boost
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Cetuximab (Erbitux)
Intervention Description
cetuximab initial dose (7 days prior to RT treatment start): 400 mg/m² body surface cetuximab weekly doses (from RT treatment start throughout radiation treatment): 250 mg/m² body surface
Primary Outcome Measure Information:
Title
Number of Participants with acute adverse effects as a Measure of toxicity
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
Time Frame
6 weeks post completion of therapy
Title
Number of Participants with late adverse effects as a Measure of toxicity
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
Time Frame
3 years post completion of treatment
Secondary Outcome Measure Information:
Title
local relapse-free survival
Description
Local relapse-free survival will be defined as the time from the initial dose of study therapy to the time of locoregional disease progression or relapse or death, or to the date of last assessment without any such event (censored observation)
Time Frame
at 3 years post treatment
Title
distant relapse-free survival
Description
Distant relapse-free survival will be defined as the time from the initial dose of study therapy to the time of distant metastasis detection or death, or to the date of last assessment without any such event (censored observation)
Time Frame
at 3 years post treatment
Title
overall disease-free survival
Description
Distant disease-free survival will be defined as the time from the initial dose of study therapy to the time of any detection of adenoid cystic carcinoma relapse or development of secondary cancer or death, or to the date of last assessment without any such event (censored observation)
Time Frame
at 3 years post treatment
Title
overall survival
Description
The duration of survival will be determined by measuring the time interval from initial dose of study therapy to the date of death of any cause or last observation (censored)
Time Frame
at 3 years post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra D Jensen, MD MSc
Phone
+49-6221-56-
Ext
8202
Email
alexandra.jensen@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Marc W Münter, MD
Phone
+49-6221-56-
Ext
8202
Email
marc.muenter@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Debus, Prof. Dr. Dr.
Organizational Affiliation
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Radiation Oncology
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleandra D Jensen, MD MSc
Phone
+49-6221-56
Ext
8202
Email
alexandra.jensen@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Alexandra D Jensen, MD MSc
12. IPD Sharing Statement
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Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy
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