Status:
UNKNOWN
Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
University Hospital Heidelberg
Conditions:
Adenoid Cystic Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 treat...
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 thera...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01192087
Start Date
June 1 2012
End Date
July 1 2017
Last Update
April 24 2013
Active Locations (1)
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1
Dept. of Radiation Oncology
Heidelberg, Germany, 69120