Squamous Cell Carcinoma Of The Head And NeckPhase 2NCT03830385
Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
A Phase 2 study testing PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin in people with Squamous Cell Carcinoma Of The Head And Neck, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma Of The Head And Neck
- What is being tested?
- PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2019to 15 Feb 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy proved squamous cell carcinoma of the head and neck;
- stage IVc according to Union for International Cancer Control (UICC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
- 18 years or older; without other malignancy;
- proper functioning of the major organs.
Who cannot join
- allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ;
- female within gestation period or lactation;
- patients received drug of other clinical trial within 3 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Zhihua Li, PhD
About this study
Official title: Open-Label, Multicenter, Phase Ⅱ Study Of Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin As First-Line Treatment In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck
- Being tested
- PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or CarboplatinDrug
All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or | Experimental | Not described Receives: Drug: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start15 Feb 2019
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma Of The Head And NeckStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830385
- Sponsor's protocol ID
- B2018-138
- Status last verified
- Jul 2019
- First submitted
- 31 Jan 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter, Phase Ⅱ Study Of Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin As First-Line Treatment In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
- ClinicalTrials.gov ID
- NCT03830385
- Acronym / sponsor ID
- B2018-138
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 5 Feb 2019 (actual)
- 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 purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or | Experimental | Drug: PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- biopsy proved squamous cell carcinoma of the head and neck;
- stage IVc according to Union for International Cancer Control (UICC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;
- 18 years or older; without other malignancy;
- proper functioning of the major organs.
Key exclusion criteria (3 listed)
- allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ;
- female within gestation period or lactation;
- patients received drug of other clinical trial within 3 months
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 |
|---|---|---|
| PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or CarboplatinAll patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy | Drug | Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or |
Primary outcome
overall survival
Time frame: 5 years
overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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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.
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 PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin in people with Squamous Cell Carcinoma Of The Head And Neck, run by Sun Yat-sen University at 1 site in China.
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 4 inclusion and 3 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 16 Jul 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Cai, PhD (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2019.