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

April 23, 2013 updated by: Heidelberg University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Recruiting
        • Dept. of Radiation Oncology
        • Contact:
        • Sub-Investigator:
          • Alexandra D Jensen, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cetuximab arm
patients receive weekly cetuximab in combination with IMRT and carbon ion boost
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 Names:
  • Cetuximab (Erbitux)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks post completion of therapy
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
3 years post completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at 3 years post treatment
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)
at 3 years post treatment
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)
at 3 years post treatment
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)
at 3 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Merck KGaA, Darmstadt, Germany
University Hospital Heidelberg
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany

Investigators

  • Principal Investigator: Jürgen Debus, Prof. Dr. Dr., Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (ESTIMATE)

August 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACCEPT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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