Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT01689194
Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
A Phase 2 study testing genexolPM + cisplatin in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- genexolPM + cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Feb 2013to 31 Aug 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- locally advanced head and neck squamous cell carcinoma
- oral cavity, oropharynx, hypopharynx, larynx
- measurable lesion
- unresectable
- age 18 or more
- ECOG 0 or 1
Who cannot join
- distant metastasis
- pregnancy
- prior chemotherapy or radiation therapy
- 2ndary malignancy
- other unfit medical condition
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, 110-744
Seoul National University Hospital
Seoul
About this study
Official title: A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
- Being tested
- genexolPM + cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genexolPM + cisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| genexolPM + cisplatin | Experimental | Not described Receives: Drug: genexolPM + cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
RECIST
Measured: every 2 cycles, 6wk later after chemotherapy
Secondary outcomes (3)
Locoregional control rate
NCI CTCAE
Measured: every 3wk (every cycle)
Quality of life
EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)
Measured: every 3wk (every cycle)
safety
NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity
Measured: every 3wk (every cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completionApr 2016
- Study completion31 Aug 2017
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 Locally Advanced Head and Neck Squamous Cell CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 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, Se-Hoon Lee, Seoul National University Hospital
- Investigators
- Se-Hoon Lee, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689194
- Sponsor's protocol ID
- CRCST-L-0007
- Other IDs
- H-1204-103-407
- Status last verified
- Dec 2020
- First submitted
- 30 Aug 2012
- Last updated
- 8 Dec 2020
- Results posted
- No
Publications
Keam B, Lee KW, Lee SH, Kim JS, Kim JH, Wu HG, Eom KY, Kim S, Ahn SH, Chung EJ, Kwon SK, Jeong WJ, Jung YH, Kim JW, Heo DS. A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Oncologist. 2019 Jun;24(6):751-e231. doi: 10.1634/theoncologist.2019-0070. Epub 2019 Feb 22.
PubMed 30796155
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
- ClinicalTrials.gov ID
- NCT01689194
- Acronym / sponsor ID
- CRCST-L-0007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Clinical Research Center for Solid Tumor, Korea
- Study start
- Feb 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 21 Sep 2012 (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.
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| genexolPM + cisplatin | Experimental | Drug: genexolPM + cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- locally advanced head and neck squamous cell carcinoma
- oral cavity, oropharynx, hypopharynx, larynx
- measurable lesion
- unresectable
- age 18 or more
Key exclusion criteria (5 listed)
- distant metastasis
- pregnancy
- prior chemotherapy or radiation therapy
- 2ndary malignancy
- other unfit medical condition
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 |
|---|---|---|
| genexolPM + cisplatin | Drug | genexolPM + cisplatin |
Primary outcome
response rate
Time frame: every 2 cycles, 6wk later after chemotherapy
RECIST
3 secondary outcomes
Locoregional control rate
Time frame: every 3wk (every cycle)
Quality of life
Time frame: every 3wk (every cycle)
safety
Time frame: every 3wk (every cycle)
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 8 Dec 2020.
- Derived from this study: PubMed 30796155Keam B, Lee KW, Lee SH, Kim JS, Kim JH, Wu HG, Eom KY, Kim S, Ahn SH, Chung EJ, Kwon SK, Jeong WJ, Jung YH, Kim JW, Heo DS. A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Oncologist. 2019 Jun;24(6):751-e231. doi: 10.1634/theoncologist.2019-0070. Epub 2019 Feb 22.
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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.
Se-Hoon Lee, MD PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing genexolPM + cisplatin in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Seoul National University Hospital at 2 sites 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 6 inclusion and 5 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: every 2 cycles, 6wk later after chemotherapy). 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 NCT01689194, 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 8 Dec 2020.