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Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy

NCT01192087 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2013-04-24

No results posted yet for this study

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

Conditions

  • Adenoid Cystic Carcinoma

Interventions

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

Sponsors & Collaborators

  • Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany

    collaborator UNKNOWN

  • University Hospital Heidelberg

    collaborator OTHER

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • Heidelberg University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-07-31
Completion
2017-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01192087 on ClinicalTrials.gov