Advanced Nasopharyngeal CarcinomaNCT03723343
GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Distant Metastatic Nasopharyngeal Carcinoma
An observational study of Advanced Nasopharyngeal Carcinoma, run by Guiyang Medical University at 1 site in China.
Trial summary
Mainly compared with GP induction chemotherapy combined with IMRT and TPF induction chemotherapy combined with IMRT in the treatment of nasopharyngeal carcinoma, the cure rate, remission rate, treatment of distant metastases and lymph node metastasis, quality of life improvement rate, etc. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Advanced Nasopharyngeal Carcinoma
- What is being tested?
- GP+IMRT and TPF+IMRT
- Type of treatment
- Injection or infusion
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2018to 30 Jun 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nasopharyngeal carcinoma with a distance between 18 and 65
Who may be able to join
- The pathological type is non-keratinized cancer (according to the pathological classification of the World Health Organization, WHO).
- The stage is TxNxM1 (according to the eighth edition of the AJCC staging standard) (Appendix I).
- There is evidence of distant transfer (M1).
- functional status: Karnofsky scale (KPS) > 70 (Appendix II).
- normal bone marrow function: white blood cell count > 4 × 109 / L, hemoglobin > 90g / L and platelet count > 100 × 109 / L.
- normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) <1.5 times the upper limit of normal (ULN), and alkaline phosphatase (alkaline phosphatase, ALP) < 2.5 x ULN and bilirubin < ULN.
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- normal renal function: creatinine clearance (creatinine clearance) > 60 ml / min.
- The patient must be informed of the basic content of the study and sign an informed consent form.
- -
Who cannot join
- the pathological type is WHO keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- age > 65 years old or < 18 years old.
- a history of malignant tumors, except for adequately treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
- Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
- has received radiation therapy (if it is non-melanoma skin cancer and the previous lesion is placed
- Except for the target area of treatment.
- primary lesions and cervical metastases have received chemotherapy or surgery (except for diagnostic treatment).
- accompanied by other serious diseases, may bring greater risk or affect the compliance of the test. For example: unstable heart disease, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose > 1.5 x ULN), and mental illness. -
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Jinhua Long, Master, 085186512802, longjinhua100@sina.cn
Feng Jin
About this study
Official title: Prospective Phase II Clinical Study of GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Nasopharyngeal Carcinoma
Mainly compared with GP induction chemotherapy combined with IMRT and TPF induction chemotherapy combined with IMRT in the treatment of nasopharyngeal carcinoma, the cure rate, remission rate, treatment of distant metastases and lymph node metastasis, quality of life improvement rate, etc.
Read the detailed description
- The main purpose: Whether the GP program can improve the efficiency of patients with nasopharyngeal carcinoma, especially overall survival (OS), in the TPF program. 2. Secondary purpose: To compare the progression-free survival (PFS) local failure-free survival (LR-FFS), the short-term remission rate of the tumor, the adverse chemotherapy response, and the treatment compliance Sex, as well as quality of life. 3. Significance of the research project Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Platinum-based chemotherapy is used in the treatment of distant metastasis and metastasis. It can effectively alleviate local symptoms and reduce local symptoms. The tumor volume thereby reduces the high dose area of the target area. Primary lesions and lymphatic drainage area radiotherapy can reduce tumor burden, relieve symptoms, and improve quality of life.
- Conditions
- Advanced Nasopharyngeal Carcinoma
- Being tested
- GP+IMRT, TPF+IMRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP+IMRTDrug
Also called Experimental group
Gemcitabine 1000 mg/m2 intravenously, d1\&d8 +Cisplatin 80 mg/m2 intravenously, d1 21~28 days/cycle, 4 patients with oligometastasis, 6 cycles with multiple metastases
TPF+IMRTDrug
Also called Control group
Docetaxel: 75mg/m2 intravenous drip, d1+Cisplatin75mg/m2 intravenous drip, d1~d5+5-fluorouracil 750mg/m2/d intravenous drip, d1~d521~28 days/cycle, patients with oligometastasis take 4 cycles, moreTransfer patients for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Experimental: GP+IMRT | Test group: GP-induced chemotherapy (Gemcitabine 1000 mg/m2 d1, 8+Cisplatin 80 mg/m2 d1, once every 3 weeks, 4/6 course) + IMRT radiotherapy alone Receives: Drug: GP+IMRT | |
| Active Comparator: TPF+IMRT | Control group: TPF-induced chemotherapy (Docetaxel: 75 mg/m2d1, Cisplatin 75 mg/m2, d1~d5, 5-fluorouracil 750 mg/m2/dd1~d5, 4/6 course) + IMRT radiotherapy alone Receives: Drug: TPF+IMRT |
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 posted29 Oct 2018
- Study start18 Oct 2018 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Guiyang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jing, Guiyang Medical University
- Investigators
- Jinhua Long, Master, Principal investigator, Guizhou Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723343
- Sponsor's protocol ID
- 201805045
- Status last verified
- Oct 2018
- First submitted
- 18 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Clinical Study of GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03723343
- Acronym / sponsor ID
- 201805045
- Conditions
- Advanced Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Guiyang Medical UniversityUniversity, hospital or other
- Study start
- 18 Oct 2018 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 29 Oct 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.
Mainly compared with GP induction chemotherapy combined with IMRT and TPF induction chemotherapy combined with IMRT in the treatment of nasopharyngeal carcinoma, the cure rate, remission rate, treatment of distant metastases and lymph node metastasis, quality of life improvement rate, etc.
Detailed description
- The main purpose: Whether the GP program can improve the efficiency of patients with nasopharyngeal carcinoma, especially overall survival (OS), in the TPF program. 2. Secondary purpose: To compare the progression-free survival (PFS) local failure-free survival (LR-FFS), the short-term remission rate of the tumor, the adverse chemotherapy response, and the treatment compliance Sex, as well as quality of life. 3. Significance of the research project Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Platinum-based chemotherapy is used in the treatment of distant metastasis and metastasis. It can effectively alleviate local symptoms and reduce local symptoms. The tumor volume thereby reduces the high dose area of the target area. Primary lesions and lymphatic drainage area radiotherapy can reduce tumor burden, relieve symptoms, and improve quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: GP+IMRT | – | Drug: GP+IMRTTest group: GP-induced chemotherapy (Gemcitabine 1000 mg/m2 d1, 8+Cisplatin 80 mg/m2 d1, once every 3 weeks, 4/6 course) + IMRT radiotherapy alone |
| Active Comparator: TPF+IMRT | – | Drug: TPF+IMRTControl group: TPF-induced chemotherapy (Docetaxel: 75 mg/m2d1, Cisplatin 75 mg/m2, d1~d5, 5-fluorouracil 750 mg/m2/dd1~d5, 4/6 course) + IMRT radiotherapy alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nasopharyngeal carcinoma with a distance between 18 and 65
Key inclusion criteria (9 listed)
- The pathological type is non-keratinized cancer (according to the pathological classification of the World Health Organization, WHO).
- The stage is TxNxM1 (according to the eighth edition of the AJCC staging standard) (Appendix I).
- There is evidence of distant transfer (M1).
- functional status: Karnofsky scale (KPS) > 70 (Appendix II).
- normal bone marrow function: white blood cell count > 4 × 109 / L, hemoglobin > 90g / L and platelet count > 100 × 109 / L.
Key exclusion criteria (8 listed)
- the pathological type is WHO keratinized squamous cell carcinoma or basal squamous cell carcinoma.
- age > 65 years old or < 18 years old.
- a history of malignant tumors, except for adequately treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ.
- Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment).
- has received radiation therapy (if it is non-melanoma skin cancer and the previous lesion is placed
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+IMRTAlso: Experimental groupGemcitabine 1000 mg/m2 intravenously, d1\&d8 +Cisplatin 80 mg/m2 intravenously, d1 21~28 days/cycle, 4 patients with oligometastasis, 6 cycles with multiple metastases | Drug | Experimental: GP+IMRT |
| TPF+IMRTAlso: Control groupDocetaxel: 75mg/m2 intravenous drip, d1+Cisplatin75mg/m2 intravenous drip, d1~d5+5-fluorouracil 750mg/m2/d intravenous drip, d1~d521~28 days/cycle, patients with oligometastasis take 4 cycles, moreTransfer patients for 6 cycles | Drug | Active Comparator: TPF+IMRT |
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 29 Oct 2018.
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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.
Jinhua Long, 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?
An observational study of 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 9 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 29 Oct 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.
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 29 Oct 2018.