Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT03117257
Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced SCCHN
A Phase 2 study testing Lobaplatin and Cisplatin in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Guiyang Medical University at 1 site in China.
Trial summary
This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Lobaplatin and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2016to 20 Aug 2021
- 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
- Voluntary participation and written informed consent
- Age 18-70 years old, gender is not limited
- histologically proved to be squamous cell carcinoma
- No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period.
- After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients
- Karnofsky score ≥70
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- Survival is expected to be ≥ 6 months
- Women of childbearing age should be guaranteed contraception during the study period
- (WBC) ≥4 × 109 / L * (unit normal), platelet (PLT) ≥100 × 109 / L (unit normal value), neutrophil cell (WBC), hematocrit (WBC) ≥1.5 × 109 / L * (unit normal value)
- liver function: alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) <upper limit of normal (ULN) 1.5 times; total bilirubin <1.5 × ULN
- renal function: serum creatinine <1.5 × ULN, endogenous creatinine clearance rate (Ccr) ≥ 55 ml / min
- no serious complications such as hypertension, diabetes, coronary heart disease and psychiatric history
- The treatment for the first course of treatment (no head and neck radiotherapy, no chemotherapy within 3 months).
Who cannot join
- There is a distant shift
- primary lesions or lymph nodes were radiotherapy
- had received epidermal growth factor targeted therapy
- primary tumor had received chemotherapy or immunotherapy
- had other malignancies (except for cured basal cell carcinoma or cervical cancer)
- pregnant women or lactating women and treatment during the observation period of contraceptive women of childbearing age
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- have a serious history of allergies or specific physical
- Abuse of drugs or alcohol addicts
- Person who has personality or mental illness, no civil capacity or limited civil capacity
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Feng Jin, Bachelor, 0851-86512802, jinf8865@yahoo.com.cn
Weili Wu, master
About this study
Official title: A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.
Read the detailed description
TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.
- Being tested
- Lobaplatin, Cisplatin
- Keywords
- Lobaplatin, head and neck cancer, chronic-chemotherapy
- 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.
LobaplatinDrug
Also called Platinum
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
CisplatinDrug
Also called cis-DDP; cis-Diammineplatinum(II) dichloride;
Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| the treatment group | Experimental | docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy Receives: Drug: Lobaplatin |
| the control group | Active comparator | TPF induction chemotherapy combined with cisplatin chemoradiotherapy Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Cancer Institute CTCAE v4.0
Acute toxicity of radiotherapy and chemotherapy
Measured: 1 year
evaluation of immediate efficacy
Evaluation of efficacy by RESIST1.1 standard
Measured: 1 year
Secondary outcomes (2)
overall survival
Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST.
Measured: 5 years
progression-free survival
Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
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 posted17 Apr 2017
- Study start19 Aug 2016
- Primary completion19 Aug 2019 (estimated)
- Study completion20 Aug 2021 (estimated)
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiyang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jing, Guiyang Medical University
- Investigators
- Feng Jin, Bachelor, Study chair, Guizhou Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117257
- Sponsor's protocol ID
- 20160819
- Status last verified
- Apr 2017
- First submitted
- 2 Apr 2017
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Chen Y, Wu W, Jin F, Li Y, Long J, Luo X, Gong X, Chen X, Liu L, Tang H, Wang Z. A prospective phase II randomized study of docetaxel combined with lobaplatin versus TPF regimen induction chemotherapy followed by concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma. J Cancer Res Clin Oncol. 2023 Dec;149(20):18081-18091. doi: 10.1007/s00432-023-05497-1. Epub 2023 Nov 20.
PubMed 37985501
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Randomized Clinical Trial: Docetaxel and Loplatin Induction Chemotherapy Followed by Concurrent Lobaplatin Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03117257
- Acronym / sponsor ID
- 20160819
- Keywords
- Lobaplatin, head and neck cancer, chronic-chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Guiyang Medical UniversityUniversity, hospital or other
- Study start
- 19 Aug 2016 (actual)
- Primary completion
- 19 Aug 2019 (estimated)
- Study completion
- 20 Aug 2021 (estimated)
- First posted
- 17 Apr 2017 (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.
This study is to observe and compare the safety and tolerability of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma.
Detailed description
TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients. Therefore, how to improve the efficacy of the same time to reduce adverse drug reactions, as a prominent problem. Lobaplatin as the third generation of platinum antitumor drugs, anti-cancer activity and cisplatin rather, more than carboplatin. In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the treatment group | Experimental | Drug: Lobaplatindocetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy |
| the control group | Active comparator | Drug: CisplatinTPF induction chemotherapy combined with cisplatin chemoradiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary participation and written informed consent
- Age 18-70 years old, gender is not limited
- histologically proved to be squamous cell carcinoma
- No surgery: head and neck squamous cell carcinoma 2010UICC staging Ⅲ - ⅣA, ⅣB period.
- After surgery: 2010UICC staging ⅣA, ⅣB;stage III tongue base or hypopharyngeal primaries;Postoperative naked eye or image residual stage III patients
Key exclusion criteria (9 listed)
- There is a distant shift
- primary lesions or lymph nodes were radiotherapy
- had received epidermal growth factor targeted therapy
- primary tumor had received chemotherapy or immunotherapy
- had other malignancies (except for cured basal cell carcinoma or cervical cancer)
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 |
|---|---|---|
| LobaplatinAlso: PlatinumDevice: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy | Drug | the treatment group |
| CisplatinAlso: cis-DDP; cis-Diammineplatinum(II) dichloride;Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy | Drug | the control group |
Primary outcome
National Cancer Institute CTCAE v4.0
Time frame: 1 year
Acute toxicity of radiotherapy and chemotherapy
evaluation of immediate efficacy
Time frame: 1 year
Evaluation of efficacy by RESIST1.1 standard
2 secondary outcomes
overall survival
Time frame: 5 years
progression-free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Derived from this study: PubMed 37985501Zhang M, Chen Y, Wu W, Jin F, Li Y, Long J, Luo X, Gong X, Chen X, Liu L, Tang H, Wang Z. A prospective phase II randomized study of docetaxel combined with lobaplatin versus TPF regimen induction chemotherapy followed by concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma. J Cancer Res Clin Oncol. 2023 Dec;149(20):18081-18091. doi: 10.1007/s00432-023-05497-1. Epub 2023 Nov 20.
- Individual participant dataSharing planned: No
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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.
Feng Jin, Bachelor study chair
Guizhou Provincial Cancer Hospital
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 Lobaplatin and Cisplatin in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Guiyang Medical 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 13 inclusion and 9 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 17 Apr 2017. 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 Feng Jin, Bachelor (86-851-86512802, jinf8865@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Cancer Institute CTCAE v4.0 (time frame: 1 year). 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 NCT03117257, 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 17 Apr 2017.