Adenoid Cystic CarcinomaPhase 1/2ACCEPTNCT01192087
Adenoid Cystic Carcinoma, Erbitux, and Particle Therapy
A Phase 1/2 study testing Cetuximab in people with Adenoid Cystic Carcinoma, run by Heidelberg University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adenoid Cystic Carcinoma
- What is being tested?
- Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Jul 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Radiation Oncology
Heidelberg, 69120
Aleandra D Jensen, MD MSc, +49-6221-56 ext. 8202, alexandra.jensen@med.uni-heidelberg.de
Alexandra D Jensen, MD MSc
About this study
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
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
Read the 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.
- Conditions
- Adenoid Cystic Carcinoma
- Being tested
- Cetuximab
- Keywords
- adenoid cystic carcinoma, carbon ion therapy, IMRT (intensity-modulated therapy), radioimmunotherapy, Cetuximab
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Cetuximab (Erbitux)
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
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab arm | Experimental | patients receive weekly cetuximab in combination with IMRT and carbon ion boost Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks post completion of therapy
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
Measured: 3 years post completion of treatment
Secondary outcomes (4)
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)
Measured: at 3 years post treatment
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)
Measured: at 3 years post treatment
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)
Measured: at 3 years post treatment
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)
Measured: at 3 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startJun 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany, University Hospital Heidelberg, Merck KGaA, Darmstadt, Germany
- Investigators
- Jürgen Debus, Prof. Dr. Dr., Principal investigator, Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192087
- Sponsor's protocol ID
- ACCEPT
- Acronym
- ACCEPT
- Status last verified
- Apr 2013
- First submitted
- 30 Aug 2010
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen AM, Bucci MK, Weinberg V, Garcia J, Quivey JM, Schechter NR, Phillips TL, Fu KK, Eisele DW. Adenoid cystic carcinoma of the head and neck treated by surgery with or without postoperative radiation therapy: prognostic features of recurrence. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):152-9. doi: 10.1016/j.ijrobp.2006.04.014.
PubMed 16904520Munter MW, Schulz-Ertner D, Hof H, Nikoghosyan A, Jensen A, Nill S, Huber P, Debus J. Inverse planned stereotactic intensity modulated radiotherapy (IMRT) in the treatment of incompletely and completely resected adenoid cystic carcinomas of the head and neck: initial clinical results and toxicity of treatment. Radiat Oncol. 2006 Jun 6;1:17. doi: 10.1186/1748-717X-1-17.
PubMed 16756669Schulz-Ertner D, Nikoghosyan A, Didinger B, Munter M, Jakel O, Karger CP, Debus J. Therapy strategies for locally advanced adenoid cystic carcinomas using modern radiation therapy techniques. Cancer. 2005 Jul 15;104(2):338-44. doi: 10.1002/cncr.21158.
PubMed 15937907Schulz-Ertner D, Nikoghosyan A, Thilmann C, Haberer T, Jakel O, Karger C, Kraft G, Wannenmacher M, Debus J. Results of carbon ion radiotherapy in 152 patients. Int J Radiat Oncol Biol Phys. 2004 Feb 1;58(2):631-40. doi: 10.1016/j.ijrobp.2003.09.041.
PubMed 14751537Schulz-Ertner D, Nikoghosyan A, Jakel O, Haberer T, Kraft G, Scholz M, Wannenmacher M, Debus J. Feasibility and toxicity of combined photon and carbon ion radiotherapy for locally advanced adenoid cystic carcinomas. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):391-8. doi: 10.1016/s0360-3016(02)04511-x.
PubMed 12738314Jakel O, Kramer M, Schulz-Ertner D, Heeg P, Karger CP, Didinger B, Nikoghosyan A, Debus J. Treatment planning for carbon ion radiotherapy in Germany: review of clinical trials and treatment planning studies. Radiother Oncol. 2004 Dec;73 Suppl 2:S86-91. doi: 10.1016/s0167-8140(04)80022-7.
PubMed 15971317Huber PE, Debus J, Latz D, Zierhut D, Bischof M, Wannenmacher M, Engenhart-Cabillic R. Radiotherapy for advanced adenoid cystic carcinoma: neutrons, photons or mixed beam? Radiother Oncol. 2001 May;59(2):161-7. doi: 10.1016/s0167-8140(00)00273-5.
PubMed 11325445Douglas JG, Koh WJ, Austin-Seymour M, Laramore GE. Treatment of salivary gland neoplasms with fast neutron radiotherapy. Arch Otolaryngol Head Neck Surg. 2003 Sep;129(9):944-8. doi: 10.1001/archotol.129.9.944.
PubMed 12975266Pommier P, Liebsch NJ, Deschler DG, Lin DT, McIntyre JF, Barker FG 2nd, Adams JA, Lopes VV, Varvares M, Loeffler JS, Chan AW. Proton beam radiation therapy for skull base adenoid cystic carcinoma. Arch Otolaryngol Head Neck Surg. 2006 Nov;132(11):1242-9. doi: 10.1001/archotol.132.11.1242.
PubMed 17116822Mizoe JE, Tsujii H, Kamada T, Matsuoka Y, Tsuji H, Osaka Y, Hasegawa A, Yamamoto N, Ebihara S, Konno A; Organizing Committee for the Working Group for Head-And-Neck Cancer. Dose escalation study of carbon ion radiotherapy for locally advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):358-64. doi: 10.1016/j.ijrobp.2004.02.067.
PubMed 15380567de Haan LD, De Mulder PH, Vermorken JB, Schornagel JH, Vermey A, Verweij J. Cisplatin-based chemotherapy in advanced adenoid cystic carcinoma of the head and neck. Head Neck. 1992 Jul-Aug;14(4):273-7. doi: 10.1002/hed.2880140403.
PubMed 1381339Kaplan MJ, Johns ME, Cantrell RW. Chemotherapy for salivary gland cancer. Otolaryngol Head Neck Surg. 1986 Sep;95(2):165-70. doi: 10.1177/019459988609500206.
PubMed 3035459Suen JY, Johns ME. Chemotherapy for salivary gland cancer. Laryngoscope. 1982 Mar;92(3):235-9. doi: 10.1288/00005537-198203000-00003.
PubMed 6279995Creagan ET, Woods JE, Rubin J, Schaid DJ. Cisplatin-based chemotherapy for neoplasms arising from salivary glands and contiguous structures in the head and neck. Cancer. 1988 Dec 1;62(11):2313-9. doi: 10.1002/1097-0142(19881201)62:113.0.co;2-4.
PubMed 3179947Dreyfuss AI, Clark JR, Fallon BG, Posner MR, Norris CM Jr, Miller D. Cyclophosphamide, doxorubicin, and cisplatin combination chemotherapy for advanced carcinomas of salivary gland origin. Cancer. 1987 Dec 15;60(12):2869-72. doi: 10.1002/1097-0142(19871215)60:123.0.co;2-y.
PubMed 2824016
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01192087
- Acronym / sponsor ID
- ACCEPT / ACCEPT
- Conditions
- Adenoid Cystic Carcinoma
- Keywords
- adenoid cystic carcinoma, carbon ion therapy, IMRT (intensity-modulated therapy), radioimmunotherapy, Cetuximab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany, University Hospital Heidelberg, Merck KGaA, Darmstadt, Germany
- Study start
- Jun 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab arm | Experimental | Drug: Cetuximabpatients receive weekly cetuximab in combination with IMRT and carbon ion boost |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (17 listed)
- Prior RT or chemotherapy for tumors of the head and neck
- R0 resection
- M1 (distant metastases)
- prior immunotherapy
- signs of active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: Cetuximab (Erbitux)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 | Drug | Cetuximab arm |
Primary outcome
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
4 secondary outcomes
local relapse-free survival
Time frame: at 3 years post treatment
distant relapse-free survival
Time frame: at 3 years post treatment
overall disease-free survival
Time frame: at 3 years post treatment
overall survival
Time frame: at 3 years post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
- Background: PubMed 16904520Chen AM, Bucci MK, Weinberg V, Garcia J, Quivey JM, Schechter NR, Phillips TL, Fu KK, Eisele DW. Adenoid cystic carcinoma of the head and neck treated by surgery with or without postoperative radiation therapy: prognostic features of recurrence. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):152-9. doi: 10.1016/j.ijrobp.2006.04.014.
- Background: PubMed 16756669Munter MW, Schulz-Ertner D, Hof H, Nikoghosyan A, Jensen A, Nill S, Huber P, Debus J. Inverse planned stereotactic intensity modulated radiotherapy (IMRT) in the treatment of incompletely and completely resected adenoid cystic carcinomas of the head and neck: initial clinical results and toxicity of treatment. Radiat Oncol. 2006 Jun 6;1:17. doi: 10.1186/1748-717X-1-17.
- Background: PubMed 15937907Schulz-Ertner D, Nikoghosyan A, Didinger B, Munter M, Jakel O, Karger CP, Debus J. Therapy strategies for locally advanced adenoid cystic carcinomas using modern radiation therapy techniques. Cancer. 2005 Jul 15;104(2):338-44. doi: 10.1002/cncr.21158.
- Background: PubMed 14751537Schulz-Ertner D, Nikoghosyan A, Thilmann C, Haberer T, Jakel O, Karger C, Kraft G, Wannenmacher M, Debus J. Results of carbon ion radiotherapy in 152 patients. Int J Radiat Oncol Biol Phys. 2004 Feb 1;58(2):631-40. doi: 10.1016/j.ijrobp.2003.09.041.
- Background: PubMed 12738314Schulz-Ertner D, Nikoghosyan A, Jakel O, Haberer T, Kraft G, Scholz M, Wannenmacher M, Debus J. Feasibility and toxicity of combined photon and carbon ion radiotherapy for locally advanced adenoid cystic carcinomas. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):391-8. doi: 10.1016/s0360-3016(02)04511-x.
- Background: PubMed 15971317Jakel O, Kramer M, Schulz-Ertner D, Heeg P, Karger CP, Didinger B, Nikoghosyan A, Debus J. Treatment planning for carbon ion radiotherapy in Germany: review of clinical trials and treatment planning studies. Radiother Oncol. 2004 Dec;73 Suppl 2:S86-91. doi: 10.1016/s0167-8140(04)80022-7.
- Background: PubMed 11325445Huber PE, Debus J, Latz D, Zierhut D, Bischof M, Wannenmacher M, Engenhart-Cabillic R. Radiotherapy for advanced adenoid cystic carcinoma: neutrons, photons or mixed beam? Radiother Oncol. 2001 May;59(2):161-7. doi: 10.1016/s0167-8140(00)00273-5.
- Background: PubMed 12975266Douglas JG, Koh WJ, Austin-Seymour M, Laramore GE. Treatment of salivary gland neoplasms with fast neutron radiotherapy. Arch Otolaryngol Head Neck Surg. 2003 Sep;129(9):944-8. doi: 10.1001/archotol.129.9.944.
- Background: PubMed 17116822Pommier P, Liebsch NJ, Deschler DG, Lin DT, McIntyre JF, Barker FG 2nd, Adams JA, Lopes VV, Varvares M, Loeffler JS, Chan AW. Proton beam radiation therapy for skull base adenoid cystic carcinoma. Arch Otolaryngol Head Neck Surg. 2006 Nov;132(11):1242-9. doi: 10.1001/archotol.132.11.1242.
- Background: PubMed 15380567Mizoe JE, Tsujii H, Kamada T, Matsuoka Y, Tsuji H, Osaka Y, Hasegawa A, Yamamoto N, Ebihara S, Konno A; Organizing Committee for the Working Group for Head-And-Neck Cancer. Dose escalation study of carbon ion radiotherapy for locally advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):358-64. doi: 10.1016/j.ijrobp.2004.02.067.
- Background: PubMed 1381339de Haan LD, De Mulder PH, Vermorken JB, Schornagel JH, Vermey A, Verweij J. Cisplatin-based chemotherapy in advanced adenoid cystic carcinoma of the head and neck. Head Neck. 1992 Jul-Aug;14(4):273-7. doi: 10.1002/hed.2880140403.
- Background: PubMed 3035459Kaplan MJ, Johns ME, Cantrell RW. Chemotherapy for salivary gland cancer. Otolaryngol Head Neck Surg. 1986 Sep;95(2):165-70. doi: 10.1177/019459988609500206.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Debus, Prof. Dr. Dr. principal investigator
Dept. of Radiation Oncology, INF 400, 69120 Heidelberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cetuximab in people with Adenoid Cystic Carcinoma, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra D Jensen, MD MSc (+49-6221-56- ext. 8202, alexandra.jensen@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with acute adverse effects as a Measure of toxicity (time frame: 6 weeks post completion of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192087, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.