ChemoradiationPhase 3ESNCCTNCT01536223
Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma
A Phase 3 study testing PF (cisplatin and 5-fluorouracil) group and TPF (docetaxel plus cisplatin and 5-fluorouracil) group in people with Chemoradiation and Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemoradiation, Nasopharyngeal Carcinoma
- What is being tested?
- PF (cisplatin and 5-fluorouracil) group and TPF (docetaxel plus cisplatin and 5-fluorouracil) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Feb 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system)
- No evidence of distant metastasis(M0)
- Performance status:KPS>70
- With normal liver function test(ALT, AST<1.5ULN)
- Renal:creatinine clearance >60ml/min
Show all 9Show fewer
- Without hematopathy,marrow:WBC>4*109/L, HGB>80G/L, and PLT>100*109/L.
- With controled blood glucose for diabetes patients
- Written informed consent
Who cannot join
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age>70 or <18
- With a history of renal disease
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0
- Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume)
- Patient is pregnant or lactating .
- Peripheral neuropathy
- Emotional disturbance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, MD, 86-571-88122098, cxzfyun@sina.com
Weifeng Qin, MD, 86-571-88122091, qinweifeng@yahoo.com.cn
About this study
Official title: Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
Read the detailed description
For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle.
After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.
- Conditions
- Chemoradiation, Nasopharyngeal Carcinoma
- Being tested
- PF (cisplatin and 5-fluorouracil) group, TPF (docetaxel plus cisplatin and 5-fluorouracil) group
- Keywords
- Nasopharyngeal Carcinoma (NPC), cisplatin and 5-fluorouracil (PF), docetaxel,cisplatin and 5-fluorouracil(TPF), Neoadjuvant Chemotherapy, intensity modulated radiotherapy(IMRT)
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF (cisplatin and 5-fluorouracil) groupDrug
Also called Active Comparator group
the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
TPF (docetaxel plus cisplatin and 5-fluorouracil) groupDrug
Also called Experiment group
3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours .
And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| PF group | Active comparator | the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy Receives: Drug: PF (cisplatin and 5-fluorouracil) group |
| TPF group | Experimental | TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy Receives: Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progress free survival(PFS)
PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.
Measured: 3 years after the inception assignment
Secondary outcomes (3)
overall survival(OS)
the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.
Measured: 2 years ,3 years and 5 years after the inception of the assignment
Adverse events
observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up.
Measured: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
local control rate (LCR)
Measured: 1 year ,2 years,3 years and 5 years after the inception of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013 (estimated)
- Study completionFeb 2015 (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 ChemoradiationStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang University, Zhejiang Provincial People's Hospital, Sir Run Run Shaw Hospital, Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Xiaozhong Chen, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536223
- Sponsor's protocol ID
- ZhejiangCH13
- Acronym
- ESNCCT
- Status last verified
- Apr 2012
- First submitted
- 13 Feb 2012
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. doi: 10.1016/j.tranon.2019.01.002. Epub 2019 Feb 20.
PubMed 30797141
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study
- ClinicalTrials.gov ID
- NCT01536223
- Acronym / sponsor ID
- ESNCCT / ZhejiangCH13
- Conditions
- Chemoradiation, Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma (NPC), cisplatin and 5-fluorouracil (PF), docetaxel,cisplatin and 5-fluorouracil(TPF), Neoadjuvant Chemotherapy, intensity modulated radiotherapy(IMRT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang University, Zhejiang Provincial People's Hospital, Sir Run Run Shaw Hospital, Wenzhou Medical University
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 20 Feb 2012 (estimated)
- 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.
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
Detailed description
For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle.
After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF group | Active comparator | Drug: PF (cisplatin and 5-fluorouracil) groupthe group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy |
| TPF group | Experimental | Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) groupTPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system)
- No evidence of distant metastasis(M0)
- Performance status:KPS>70
- With normal liver function test(ALT, AST<1.5ULN)
Key exclusion criteria (8 listed)
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age>70 or <18
- With a history of renal disease
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0
- Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume)
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 |
|---|---|---|
| PF (cisplatin and 5-fluorouracil) groupAlso: Active Comparator groupthe group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2. | Drug | PF group |
| TPF (docetaxel plus cisplatin and 5-fluorouracil) groupAlso: Experiment group3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours . And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2. | Drug | TPF group |
Primary outcome
3-year progress free survival(PFS)
Time frame: 3 years after the inception assignment
PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.
3 secondary outcomes
overall survival(OS)
Time frame: 2 years ,3 years and 5 years after the inception of the assignment
Adverse events
Time frame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
local control rate (LCR)
Time frame: 1 year ,2 years,3 years and 5 years after the inception of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Derived from this study: PubMed 30797141Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. doi: 10.1016/j.tranon.2019.01.002. Epub 2019 Feb 20.
Related trials for Chemoradiation
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Not yet recruiting
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
Stage III NSCLC
Active, not recruitingPhase 2
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
Locally Advanced Head and Neck Carcinoma
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.
Xiaozhong Chen, MD principal investigator
Zhejiang 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 PF (cisplatin and 5-fluorouracil) group and TPF (docetaxel plus cisplatin and 5-fluorouracil) group in people with Chemoradiation and Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital 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 5 Mar 2013. 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 Xiaozhong Chen, MD (86-571-88122098, cxzfyun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progress free survival(PFS) (time frame: 3 years after the inception assignment). 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 NCT01536223, 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 5 Mar 2013.