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Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy (ACCEPT)

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ClinicalTrials.gov Identifier: NCT01192087
Recruitment Status : Unknown
Verified April 2013 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : August 31, 2010
Last Update Posted : April 24, 2013
Sponsor:
Collaborators:
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
University Hospital Heidelberg
Merck KGaA, Darmstadt, Germany
Information provided by:
Heidelberg University

August 30, 2010
August 31, 2010
April 24, 2013
June 2012
July 2015   (Final data collection date for primary outcome measure)
  • Number of Participants with acute adverse effects as a Measure of toxicity [ Time Frame: 6 weeks post completion of therapy ]
    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 [ Time Frame: 3 years post completion of treatment ]
    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
Same as current
Complete list of historical versions of study NCT01192087 on ClinicalTrials.gov Archive Site
  • local relapse-free survival [ Time Frame: at 3 years post treatment ]
    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 [ Time Frame: at 3 years post treatment ]
    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 [ Time Frame: at 3 years post treatment ]
    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 [ Time Frame: at 3 years post treatment ]
    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)
Same as current
Not Provided
Not Provided
 
Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy
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
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

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Adenoid Cystic Carcinoma
Drug: Cetuximab
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
Other Name: Cetuximab (Erbitux)
Experimental: Cetuximab arm
patients receive weekly cetuximab in combination with IMRT and carbon ion boost
Intervention: Drug: Cetuximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
49
Same as current
July 2017
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01192087
ACCEPT
Yes
Not Provided
Not Provided
Prof. Dr. Dr. J. Debus, Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
Heidelberg University
  • Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
  • University Hospital Heidelberg
  • Merck KGaA, Darmstadt, Germany
Principal Investigator: Jürgen Debus, Prof. Dr. Dr. Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
Heidelberg University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP