Head and Neck NeoplasmPhase 2NCT00623558
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 2 study testing Cetuximab, Docetaxel and Cisplatin in people with Head and Neck Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasm
- What is being tested?
- Cetuximab, Docetaxel and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Aug 2013
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC
- ECOG performance status 0-1
- Age 18 or older than 18 years
- Measurable disease by RECIST criteria
- Having signed informed consent
- ALT and AST<2.5 times ULN
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- Serum albumin level ≥3.0g/dL
- Serum AKP < 2.5 times ULN
- Bilirubin level < 1.5mg/dL
- Serum creatinine <1.5 times ULN
- WBC>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet>75,000/mm3, Hb>9g/dl
Who cannot join
- Previous cytotoxic chemotherapy for HNSCC
- Radiotherapy for targeted lesions within six months
- Previous EGFR pathway-targeting therapy
- Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
- Distant metastatic disease
- Heart failure, coronary artery disease, myocardial infarction within the last 6 months
Show all 11Show fewer
- Known allergy to any study treatment
- Pregnancy or lactation period
- Any investigational agent within the past 28 days
- Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
- Legal incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Neoplasm
- Keywords
- head and neck neoplasm, cetuximab, docetaxel, cisplatin, radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks
DocetaxelDrug
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
CisplatinDrug
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Docetaxel+CDDP Receives: Drug: Docetaxel; Drug: Cisplatin |
| 2 | Experimental | Docetaxel+CDDP+Cetuximab Receives: Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: after induction treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Center for Solid Tumor, Korea
- Responsible party
- Principal investigator, Dae Seog Heo, Seoul National University Hospital
- Investigators
- Dae Seog Heo, Prof., Principal investigator, Clinical Research Center for Solid Tumors, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623558
- Sponsor's protocol ID
- CRCST-L0002
- Status last verified
- Apr 2013
- First submitted
- 17 Feb 2008
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24.
PubMed 26304911
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT00623558
- Acronym / sponsor ID
- CRCST-L0002
- Conditions
- Head and Neck Neoplasm
- Keywords
- head and neck neoplasm, cetuximab, docetaxel, cisplatin, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Clinical Research Center for Solid Tumor, Korea
- Study start
- Apr 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Feb 2008 (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 aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Docetaxel, Drug: CisplatinDocetaxel+CDDP |
| 2 | Experimental | Drug: Cetuximab, Drug: Docetaxel, Drug: CisplatinDocetaxel+CDDP+Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC
- ECOG performance status 0-1
- Age 18 or older than 18 years
- Measurable disease by RECIST criteria
- Having signed informed consent
Key exclusion criteria (11 listed)
- Previous cytotoxic chemotherapy for HNSCC
- Radiotherapy for targeted lesions within six months
- Previous EGFR pathway-targeting therapy
- Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
- Distant metastatic disease
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 |
|---|---|---|
| Cetuximab400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks | Drug | 2 |
| Docetaxel75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles) | Drug | 1, 2 |
| Cisplatin75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles) | Drug | 1, 2 |
Primary outcome
Response rate
Time frame: after induction treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
- Derived from this study: PubMed 26304911Lee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24.
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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.
Dae Seog Heo, Prof. principal investigator
Clinical Research Center for Solid Tumors, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab, Docetaxel and Cisplatin in people with Head and Neck Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
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 11 inclusion and 11 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: finished, as of the sponsor's last update on 4 Dec 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 South Korea. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: after induction treatment). 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 NCT00623558, which also lists 1 linked publication.
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 4 Dec 2013.