Head and Neck Squamous CarcinomaPhase 2NCT05039606
Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
A Phase 2 study testing Nedaplatin and Cisplatin in people with Head and Neck Squamous Carcinoma, run by Guiyang Medical University at 1 site in China.
Trial summary
This study was designed as a prospective, multicenter and randomized clinical study of radiotherapy combined with Nedaplatin contrast and cisplatin for local advanced head and neck squamous SCC, aiming to explore the efficacy, safety and long-term efficacy of this trial and control groups and provide some evidence for… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Squamous Carcinoma
- What is being tested?
- Nedaplatin and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- Sep 2021to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- voluntarily participated and signed the informed consent form in writing
- is 18-70 and gender unlimited
- histologically proved to be squamous cell carcinoma
- as AJCC(version 8): -A, ⅣB head and neck squamous carcinoma unable or denied surgery; ~ A, ⅣB squamous carcinoma of the head and neck with the following postoperative risk factors: positive or proximal resection, lymph node envelope invasion, nerve and vascular invasion, primary focal pT3 or T4, N2 or N3 lymph node lesions.
- card score ≥ 70
- survival is expected to be ≥ for 6 months
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- fertility women should guarantee contraception during entering the study
- Hemoglobin (HGB) ≥ 100 g/L, leukocyte (WBC) ≥ 3.5 × 10^9 / L*(unit normal), Platelet (PLT) ≥ 100 × 10^9 / L(unit normal), neutrophil (WBC) ≥ 1.5 × 10^9 / L*(unit normal)
- liver function: 2.5 times of the upper normal limit (ULN), gluten transaminase (ASAT) <; total bilirubin <1.5 × ULN
- renal function: Serum creatinine <ULN, endogenous creatinine clearance (Ccr) ≥ 55 ml/min
- has no severe complications such as hypertension, diabetes, coronary heart disease, and psychiatric history
- (no history of head and neck radiotherapy or chemotherapy within 3 months)
Who cannot join
- has a distant transfer
- has received epidermal growth factor targeted or immunotherapy
- has developed other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ)
- pregnant women or lactating women and women of childbearing age who refuse contraception during the treatment observation period
- has a serious history of severe allergies or abnormalities
- refused or cannot sign an informed consent to participate in the trial
- substance abuse or alcohol addicts
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Feng Jin, Bachelor, 86-13985124806, jinf8865@yahoo.com.cn
Weili Wu, Master, 86-13885124077, wwlmhy@163.com
About this study
Official title: Prospective, Multicentric, Randomized Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
This study was designed as a prospective, multicenter and randomized clinical study of radiotherapy combined with Nedaplatin contrast and cisplatin for local advanced head and neck squamous SCC, aiming to explore the efficacy, safety and long-term efficacy of this trial and control groups and provide some evidence for the selection of clinical treatment options.
Read the detailed description
Head and neck squamous cell carcinoma (HNSCC) is a common malignancy accounting for more than 90% of head and neck tumors and over 60% of patients with mid-to late stage (-b) stage at diagnosis.For patients with moderate and advanced head and neck squamous carcinoma, concurrent chemoradiotherapy and chemotherapy is recommended for category 1 and the preferred drug is cisplatin.The application of simultaneous chemoradiotherapy can significantly improve the overall survival rate of patients with locally advanced head and neck squamous carcinoma, and effectively reduce their local recurrence rate and distant metastasis rate.However, the application of cisplatin aggravates the toxic and side reactions, such as nausea and vomiting, radioactive oral mucosal response, nephrotoxicity and ear toxicity.Although the clinical benefit of synchronous chemochemotherapy of locally advanced head and neck squamous carcinoma with cisplatin as chemotherapy is considerable, due to its obvious toxic and side reaction, some patients can not tolerate, cannot complete the whole course of treatment and quality of life, resulting in a substantial reduction in the treatment effect.Therefore, in synchronous chemoradiotherapy of locally advanced head and NSCC, there is an urgent need to find an efficient, hypotoxic, novel chemotherapeutic agent to address this problem.
Nedaplatin is the second generation platinum derivative, for cell cycle nonspecific drugs, mechanism and efficacy similar to cisplatin, anticancer spectrum, and cisplatin without drug resistance, cisplatin resistance still has a good effect, its gastrointestinal reaction and nephrotoxicity is significantly reduced, main dose-limiting toxicity, grade marrow suppression, clinical application without hydration, patients good tolerance and convenient to use, can significantly improve the quality of life of patients.A number of foreign studies have found that nedaplatin combination chemotherapy is effective in esophageal cancer, non-small cell lung cancer and cervical cancer, patients are tolerated, and the digestive tract response is significantly reduced, which helps to ensure the integrity of the course of treatment.Wang Zhennan and other studies reported that nedaplatin can improve the radiosensitivity of NPC CNE-2 cells and show dose-dependent inhibition of tumor cells.Koizumi et al also found that nedaplatin with radiotherapy could effective sensitization.In addition, the results of a phase III randomized controlled trial from the Cancer Center of Sun Yat-sen University, which showed that the overall efficiency of nedaplatin combined radiotherapy for local advanced NPC and 2-year progression-free survival rate were no less than cisplatin (88.7%vs89.7%), and compared with the cisplatin group, gastrointestinal loss, nausea, vomiting and weight loss quality score were significantly improved.
- Conditions
- Head and Neck Squamous Carcinoma
- Being tested
- Nedaplatin, Cisplatin
- Keywords
- Local advanced head and neck squamous carcinoma, Nedaplatin, Adverse reactions, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NedaplatinDrug
Nedaplatin is a second-generation platinum-like derivative, which is a cell cycle non-specific drug, with a mechanism of action and efficacy similar to cisplatin, and a wide anti-cancer spectrum
CisplatinDrug
Cisplatin, aka cis-dichlorodiamineplatin, is a platinum-containing anticancer drug
| Study group | Role | What they receive |
|---|---|---|
| the treatment group | Experimental | Nedplatin combined with intensive radiotherapy group Receives: Drug: Nedaplatin |
| the control group | Active comparator | Cisplatin was combined with the IMRT group Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCI CTCAE 5.0
Acute virulence side response
Measured: 1 year
RESIST1.1
Use to assess recent efficacy
Measured: 1year
Secondary outcomes (2)
overall survival
Overall survival was assessed at 5 years after the end of chemoradiotherapy during the same period
Measured: 5 years
Progression-free survival rate
Progression-free survival rate was assessed at 5 years after the end of chemoradiotherapy
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 posted9 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous 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
- 164 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, The Affiliated Cancer Hospital of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039606
- Sponsor's protocol ID
- 20210829
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Randomized Clinical Study of Radiotherapy Combined With Nedaplatin Contrast and Cisplatin for the Treatment of Locally Advanced Head and Neck Squamous Carcinoma
- ClinicalTrials.gov ID
- NCT05039606
- Acronym / sponsor ID
- 20210829
- Conditions
- Head and Neck Squamous Carcinoma
- Keywords
- Local advanced head and neck squamous carcinoma, Nedaplatin, Adverse reactions, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Guiyang Medical UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Sep 2021 (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 was designed as a prospective, multicenter and randomized clinical study of radiotherapy combined with Nedaplatin contrast and cisplatin for local advanced head and neck squamous SCC, aiming to explore the efficacy, safety and long-term efficacy of this trial and control groups and provide some evidence for the selection of clinical treatment options.
Detailed description
Head and neck squamous cell carcinoma (HNSCC) is a common malignancy accounting for more than 90% of head and neck tumors and over 60% of patients with mid-to late stage (-b) stage at diagnosis.For patients with moderate and advanced head and neck squamous carcinoma, concurrent chemoradiotherapy and chemotherapy is recommended for category 1 and the preferred drug is cisplatin.The application of simultaneous chemoradiotherapy can significantly improve the overall survival rate of patients with locally advanced head and neck squamous carcinoma, and effectively reduce their local recurrence rate and distant metastasis rate.However, the application of cisplatin aggravates the toxic and side reactions, such as nausea and vomiting, radioactive oral mucosal response, nephrotoxicity and ear toxicity.Although the clinical benefit of synchronous chemochemotherapy of locally advanced head and neck squamous carcinoma with cisplatin as chemotherapy is considerable, due to its obvious toxic and side reaction, some patients can not tolerate, cannot complete the whole course of treatment and quality of life, resulting in a substantial reduction in the treatment effect.Therefore, in synchronous chemoradiotherapy of locally advanced head and NSCC, there is an urgent need to find an efficient, hypotoxic, novel chemotherapeutic agent to address this problem.
Nedaplatin is the second generation platinum derivative, for cell cycle nonspecific drugs, mechanism and efficacy similar to cisplatin, anticancer spectrum, and cisplatin without drug resistance, cisplatin resistance still has a good effect, its gastrointestinal reaction and nephrotoxicity is significantly reduced, main dose-limiting toxicity, grade marrow suppression, clinical application without hydration, patients good tolerance and convenient to use, can significantly improve the quality of life of patients.A number of foreign studies have found that nedaplatin combination chemotherapy is effective in esophageal cancer, non-small cell lung cancer and cervical cancer, patients are tolerated, and the digestive tract response is significantly reduced, which helps to ensure the integrity of the course of treatment.Wang Zhennan and other studies reported that nedaplatin can improve the radiosensitivity of NPC CNE-2 cells and show dose-dependent inhibition of tumor cells.Koizumi et al also found that nedaplatin with radiotherapy could effective sensitization.In addition, the results of a phase III randomized controlled trial from the Cancer Center of Sun Yat-sen University, which showed that the overall efficiency of nedaplatin combined radiotherapy for local advanced NPC and 2-year progression-free survival rate were no less than cisplatin (88.7%vs89.7%), and compared with the cisplatin group, gastrointestinal loss, nausea, vomiting and weight loss quality score were significantly improved.
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: NedaplatinNedplatin combined with intensive radiotherapy group |
| the control group | Active comparator | Drug: CisplatinCisplatin was combined with the IMRT group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- voluntarily participated and signed the informed consent form in writing
- is 18-70 and gender unlimited
- histologically proved to be squamous cell carcinoma
- as AJCC(version 8): -A, ⅣB head and neck squamous carcinoma unable or denied surgery; ~ A, ⅣB squamous carcinoma of the head and neck with the following postoperative risk factors: positive or proximal resection, lymph node envelope invasion, nerve and vascular invasion, primary focal pT3 or T4, N2 or N3 lymph node lesions.
- card score ≥ 70
Key exclusion criteria (7 listed)
- has a distant transfer
- has received epidermal growth factor targeted or immunotherapy
- has developed other malignant tumors (except for cured basal cell carcinoma or cervical carcinoma in situ)
- pregnant women or lactating women and women of childbearing age who refuse contraception during the treatment observation period
- has a serious history of severe allergies or abnormalities
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 |
|---|---|---|
| NedaplatinNedaplatin is a second-generation platinum-like derivative, which is a cell cycle non-specific drug, with a mechanism of action and efficacy similar to cisplatin, and a wide anti-cancer spectrum | Drug | the treatment group |
| CisplatinCisplatin, aka cis-dichlorodiamineplatin, is a platinum-containing anticancer drug | Drug | the control group |
Primary outcome
NCI CTCAE 5.0
Time frame: 1 year
Acute virulence side response
RESIST1.1
Time frame: 1year
Use to assess recent efficacy
2 secondary outcomes
overall survival
Time frame: 5 years
Progression-free survival rate
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 9 Sep 2021.
- 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
The Affiliated Cancer Hospital of Guizhou Medical University
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 Nedaplatin and Cisplatin in people with Head and Neck Squamous 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 12 inclusion and 7 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 9 Sep 2021. 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?
NCI CTCAE 5.0 (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?
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 9 Sep 2021.