Locally Advanced Nasopharyngeal CarcinomaPhase 3NCT03604965
GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC
A Phase 3 study testing GP+CCRT and TPF+CCRT in people with Locally Advanced Nasopharyngeal Carcinoma, run by Guiyang Medical University at 1 site in China.
Trial summary
Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Locally Advanced Nasopharyngeal Carcinoma
- What is being tested?
- GP+CCRT and TPF+CCRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2018to 21 Jul 2020
- Phase
- Phase 3
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.
- Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
- III, IVa patients (AJCC version 8 staging).
- Male or non-pregnant women.
- Age ≥ 18 and < 70 years old.
- Functional status: Karnofsky scale (KPS) > 70.
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- White blood cells (WBC) ≥ 4 × 109.
- /L, hemoglobin (HGB) ≥ 90 g / L, platelets (PLT) ≥ 100 × 109 / L (or within the normal range of the laboratory)
- Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN.
- Renal function: creatinine clearance ≥ 60ml / min or serum creatinine ≤ 1.5 × ULN.
- The patient has signed an informed consent form.
Who cannot join
- The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- Age ≥ 70 years old or < 18 years old.
- Treatment is palliative.
- Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
- Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).
- Previously received radiation therapy (if non-melanoma skin cancer and previous lesions are outside the target area of radiotherapy, then except).
- Primary and cervical metastatic lesions received chemotherapy or surgery (except for diagnostic treatment).
- With other serious diseases, it may bring greater risk or affect the compliance of the test. For example: no need for treatment Stable heart disease, kidney disease, chronic hepatitis, control of unsatisfactory diabetes (fasting blood glucose > 1.5 × ULN),And mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Yuanyuan Li, master, 085186512802, lilyuanyuan@qq.com
Feng Jin, Bachelor
About this study
Official title: A Multicenter, Randomized Controlled Phase III Clinical Trial of GP Induction Chemotherapy With TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.
- Being tested
- GP+CCRT, TPF+CCRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP+CCRTDrug
Also called Experimental group
Patients receive Neoadjuvant gemcitabine (1000mg/m2 on day1 and day8 ) and cisplatin (80mg/m2 on day1)every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy
TPF+CCRTDrug
Also called Control group
Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| GP+CCRT | Experimental | GP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy Receives: Drug: GP+CCRT |
| TPF+CCRT | Active comparator | TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy Receives: Drug: TPF+CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival(PFS)
Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
Measured: 3 years
Secondary outcomes (5)
Overall survival(OS)
The OS(year) was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Measured: 3 years
Locoregional failure-free survival(LRFS)
The LRFS(year) is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
Measured: 3 years
Distant metastasis-free survival(DMFS)
The DMFS(year) is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Measured: 3 years
Overall response rate
Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1
Measured: 3 years
Incidence of acute and late toxicity
Incidence of acute toxicity（Grade1/2/3/4） is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start21 Jul 2018
- Primary completion21 Jul 2020 (estimated)
- Study completion21 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Nasopharyngeal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 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
- Yuanyuan Li, Master, Principal investigator, Guizhou Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604965
- Sponsor's protocol ID
- 201805043
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Phase III Clinical Trial of GP Induction Chemotherapy With TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03604965
- Acronym / sponsor ID
- 201805043
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Guiyang Medical UniversityUniversity, hospital or other
- Study start
- 21 Jul 2018 (actual)
- Primary completion
- 21 Jul 2020 (estimated)
- Study completion
- 21 Jul 2020 (estimated)
- First posted
- 30 Jul 2018 (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.
Through randomized controlled phase III multicenter clinical trials, GP induction chemotherapy vs TPF regimen adjuvant chemotherapy combined with DDP concurrent chemoradiotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP+CCRT | Experimental | Drug: GP+CCRTGP neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy |
| TPF+CCRT | Active comparator | Drug: TPF+CCRTTPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- In the newly diagnosed patient, no radiotherapy or chemotherapy was performed before the start of the clinical trial.
- Pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
- III, IVa patients (AJCC version 8 staging).
- Male or non-pregnant women.
- Age ≥ 18 and < 70 years old.
Key exclusion criteria (8 listed)
- The pathological type is WHO's keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- Age ≥ 70 years old or < 18 years old.
- Treatment is palliative.
- Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
- Women during pregnancy or lactation (pregnant women should be considered for women of childbearing age; Effective contraception).
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 |
|---|---|---|
| GP+CCRTAlso: Experimental groupPatients receive Neoadjuvant gemcitabine (1000mg/m2 on day1 and day8 ) and cisplatin (80mg/m2 on day1)every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy | Drug | GP+CCRT |
| TPF+CCRTAlso: Control groupPatients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy | Drug | TPF+CCRT |
Primary outcome
Progress-free survival(PFS)
Time frame: 3 years
Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
5 secondary outcomes
Overall survival(OS)
Time frame: 3 years
Locoregional failure-free survival(LRFS)
Time frame: 3 years
Distant metastasis-free survival(DMFS)
Time frame: 3 years
Overall response rate
Time frame: 3 years
Incidence of acute and late toxicity
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- 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.
Yuanyuan Li, Master principal investigator
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 3 study testing GP+CCRT and TPF+CCRT in people with Locally Advanced Nasopharyngeal 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 11 inclusion and 8 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 30 Jul 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (0851-86512802, jinf8865@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-free survival(PFS) (time frame: 3 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 30 Jul 2018.