CisplatinPhase 3NCT03919552

Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

A Phase 3 study testing Docetaxel,Carboplatin, Docetaxel,Cisplatin and Carboplatin-based concurrent chemoradiotherapy in people with Cisplatin and Carboplatin, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Cisplatin, Carboplatin, NPC
What is being tested?: Docetaxel,Carboplatin, Docetaxel,Cisplatin and Carboplatin-based concurrent chemoradiotherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 482 participants
Where: 1 siteChina
Study dates: 31 Jan 2018to 31 Dec 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition).
No evidence of distant metastasis (M0).
Satisfactory performance status: Karnofsky scale (KPS) > 70.
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
Adequate renal function: creatinine clearance ≥60 ml/min.
Patients must be informed of the investigational nature of this study and give written informed consent.

Who cannot join

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age ≥65 years or <18 years.
Treatment with palliative intent.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation.
History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Guan, Ph.D. contact

+86-13632102247

51643930@qq.com

China1 site, 1 recruiting

Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D., 86+13632102247, guanjian5461@163.com
Jian Guan, M.D.
Recruiting

Other trials in China

About this study

Official title: Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：: A Phase 3 Trial

Read the detailed description

Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Conditions: Cisplatin, Carboplatin, NPC
Being tested: Docetaxel,Carboplatin, Docetaxel,Cisplatin, Carboplatin-based concurrent chemoradiotherapy, Cisplatin-based concurrent chemoradiotherapy
Keywords: Nasopharyngeal Carcinoma, cisplatin, carboplatin
Medical subject headings: Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Docetaxel,CarboplatinDrug
Also called TC induction chemotherapy
Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
Docetaxel,CisplatinDrug
Also called TP induction chemotherapy
Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
Carboplatin-based concurrent chemoradiotherapyRadiation
Also called Radical radiotherapy and concurrent carboplatin
Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
Cisplatin-based concurrent chemoradiotherapyRadiation
Also called Radical radiotherapy and concurrent cisplatin
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Study groups in NCT03919552
Study group	Role	What they receive
Carboplatin	Experimental	Patients receive carboplatin (AUC 4 on day 1) every three weeks Receives: Drug: Docetaxel,Carboplatin; Radiation: Carboplatin-based concurrent chemoradiotherapy
Cisplatin	Active comparator	Patients receive cisplatin (75mg/m2 on day 1) every three weeks Receives: Drug: Docetaxel,Cisplatin; Radiation: Cisplatin-based concurrent chemoradiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Failure-free survival
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Measured: 3-year

Secondary outcomes (5)

Locoregional failure-free survival
Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.
Measured: 3-year
Distant failure-free survival
Distant failure-free survival is calculated from randomisation to the first locoregional failure.
Measured: 3-year
The initial response rates after treatments
The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.
Measured: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.
Toxic effects
Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.
Measured: 3-year
Overall survival
Overall survival is calculated from randomization to death from any cause.
Measured: 3-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 201831 Dec 2026

First posted18 Apr 2019
Study start31 Jan 2018
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for CisplatinStudies of the same condition, open and under way.
More trials run by Nanfang Hospital, Southern Medical UniversityThe 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: Single blind
Who is masked: Investigator
Enrolment: 482 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03919552
Sponsor's protocol ID: NFEC-2018-013
Status last verified: Jun 2023
First submitted: 25 Apr 2018
Last updated: 18 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Haddad RI, Shin DM. Recent advances in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1143-54. doi: 10.1056/NEJMra0707975. No abstract available.
PubMed 18784104
Guan J, Zhang Y, Li Q, Zhang Y, Li L, Chen M, Xiao N, Chen L. A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC). Oncotarget. 2016 Oct 25;7(43):70185-70193. doi: 10.18632/oncotarget.11824.
PubMed 27602493
Hashibe M, Brennan P, Chuang SC, Boccia S, Castellsague X, Chen C, Curado MP, Dal Maso L, Daudt AW, Fabianova E, Fernandez L, Wunsch-Filho V, Franceschi S, Hayes RB, Herrero R, Kelsey K, Koifman S, La Vecchia C, Lazarus P, Levi F, Lence JJ, Mates D, Matos E, Menezes A, McClean MD, Muscat J, Eluf-Neto J, Olshan AF, Purdue M, Rudnai P, Schwartz SM, Smith E, Sturgis EM, Szeszenia-Dabrowska N, Talamini R, Wei Q, Winn DM, Shangina O, Pilarska A, Zhang ZF, Ferro G, Berthiller J, Boffetta P. Interaction between tobacco and alcohol use and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):541-50. doi: 10.1158/1055-9965.EPI-08-0347. Epub 2009 Feb 3.
PubMed 19190158
Blot WJ, McLaughlin JK, Winn DM, Austin DF, Greenberg RS, Preston-Martin S, Bernstein L, Schoenberg JB, Stemhagen A, Fraumeni JF Jr. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Res. 1988 Jun 1;48(11):3282-7.
PubMed 3365707
Chang ET, Adami HO. The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol Biomarkers Prev. 2006 Oct;15(10):1765-77. doi: 10.1158/1055-9965.EPI-06-0353.
PubMed 17035381
Klein G. Nasopharyngeal carcinoma (NPC) is an enigmatic tumor. Semin Cancer Biol. 2002 Dec;12(6):415-8. doi: 10.1016/s1044579x02000834. No abstract available.
PubMed 12450726
Buell P. The effect of migration on the risk of nasopharyngeal cancer among Chinese. Cancer Res. 1974 May;34(5):1189-91. No abstract available.
PubMed 4842361
Ozer E, Grecula JC, Agrawal A, Rhoades CA, Young DC, Schuller DE. Long-term results of a multimodal intensification regimen for previously untreated advanced resectable squamous cell cancer of the oral cavity, oropharynx, or hypopharynx. Laryngoscope. 2006 Apr;116(4):607-12. doi: 10.1097/01.mlg.0000208340.42071.f9.
PubMed 16585867
Fallai C, Bolner A, Signor M, Gava A, Franchin G, Ponticelli P, Taino R, Rossi F, Ardizzoia A, Oggionni M, Crispino S, Olmi P. Long-term results of conventional radiotherapy versus accelerated hyperfractionated radiotherapy versus concomitant radiotherapy and chemotherapy in locoregionally advanced carcinoma of the oropharynx. Tumori. 2006 Jan-Feb;92(1):41-54. doi: 10.1177/030089160609200108.
PubMed 16683383
Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.
PubMed 21684027
Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.
PubMed 27686945
Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.
PubMed 25957714
Munro AJ. An overview of randomised controlled trials of adjuvant chemotherapy in head and neck cancer. Br J Cancer. 1995 Jan;71(1):83-91. doi: 10.1038/bjc.1995.17.
PubMed 7819055
Akhlaghi F, Esmaeelinejad M, Shams A, Augend A. Evaluation of neo-adjuvant, concurrent and adjuvant chemotherapy in the treatment of head and neck squamous cell carcinoma: a meta-analysis. J Dent (Tehran). 2014 May;11(3):290-301. Epub 2014 May 31.
PubMed 25628664
Zhou Z, Tang T, Li N, Zheng Q, Xiao T, Tian Y, Sun J, Zhang L, Wang X, Wang Y, Ye F, Chen Z, Zhang H, Zheng X, Cai Z, Liu L, Guan J. VLDL and LDL Subfractions Enhance the Risk Stratification of Individuals Who Underwent Epstein-Barr Virus-Based Screening for Nasopharyngeal Carcinoma: A Multicenter Cohort Study. Adv Sci (Weinh). 2024 Jun;11(22):e2308765. doi: 10.1002/advs.202308765. Epub 2024 Mar 23.
PubMed 38520712

Interested in taking part?

Jian Guan, Ph.D.

+86-13632102247

51643930@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Cisplatin trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensity-modulated Radiation Therapy Combined With Cisplatin-based or Carboplatin-based Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：: A Phase 3 Trial
ClinicalTrials.gov ID: NCT03919552
Acronym / sponsor ID: NFEC-2018-013
Conditions: Cisplatin, Carboplatin, NPC
Keywords: Nasopharyngeal Carcinoma, cisplatin, carboplatin
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 482 participants (estimated)
Lead sponsor: Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
Study start: 31 Jan 2018 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 18 Apr 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Carboplatin	Experimental	Drug: Docetaxel,Carboplatin, Radiation: Carboplatin-based concurrent chemoradiotherapyPatients receive carboplatin (AUC 4 on day 1) every three weeks
Cisplatin	Active comparator	Drug: Docetaxel,Cisplatin, Radiation: Cisplatin-based concurrent chemoradiotherapyPatients receive cisplatin (75mg/m2 on day 1) every three weeks

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Tumor staged as T3-4Nx/TxN2-3 (according to the 8th American Joint Commission on Cancer edition).
No evidence of distant metastasis (M0).
Satisfactory performance status: Karnofsky scale (KPS) > 70.
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

Key exclusion criteria (8 listed)

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age ≥65 years or <18 years.
Treatment with palliative intent.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation.

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
Docetaxel,CarboplatinAlso: TC induction chemotherapyPatients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.	Drug	Carboplatin
Docetaxel,CisplatinAlso: TP induction chemotherapyPatients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.	Drug	Cisplatin
Carboplatin-based concurrent chemoradiotherapyAlso: Radical radiotherapy and concurrent carboplatinPatients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.	Radiation	Carboplatin
Cisplatin-based concurrent chemoradiotherapyAlso: Radical radiotherapy and concurrent cisplatinPatients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.	Radiation	Cisplatin

Primary outcome

Failure-free survival
Time frame: 3-year
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

5 secondary outcomes

Locoregional failure-free survival
Time frame: 3-year
Distant failure-free survival
Time frame: 3-year
The initial response rates after treatments
Time frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.
Toxic effects
Time frame: 3-year
Overall survival
Time frame: 3-year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Background: PubMed 18784104Haddad RI, Shin DM. Recent advances in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1143-54. doi: 10.1056/NEJMra0707975. No abstract available.
Background: PubMed 27602493Guan J, Zhang Y, Li Q, Zhang Y, Li L, Chen M, Xiao N, Chen L. A meta-analysis of weekly cisplatin versus three weekly cisplatin chemotherapy plus concurrent radiotherapy (CRT) for advanced head and neck cancer (HNC). Oncotarget. 2016 Oct 25;7(43):70185-70193. doi: 10.18632/oncotarget.11824.
Background: PubMed 19190158Hashibe M, Brennan P, Chuang SC, Boccia S, Castellsague X, Chen C, Curado MP, Dal Maso L, Daudt AW, Fabianova E, Fernandez L, Wunsch-Filho V, Franceschi S, Hayes RB, Herrero R, Kelsey K, Koifman S, La Vecchia C, Lazarus P, Levi F, Lence JJ, Mates D, Matos E, Menezes A, McClean MD, Muscat J, Eluf-Neto J, Olshan AF, Purdue M, Rudnai P, Schwartz SM, Smith E, Sturgis EM, Szeszenia-Dabrowska N, Talamini R, Wei Q, Winn DM, Shangina O, Pilarska A, Zhang ZF, Ferro G, Berthiller J, Boffetta P. Interaction between tobacco and alcohol use and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):541-50. doi: 10.1158/1055-9965.EPI-08-0347. Epub 2009 Feb 3.
Background: PubMed 3365707Blot WJ, McLaughlin JK, Winn DM, Austin DF, Greenberg RS, Preston-Martin S, Bernstein L, Schoenberg JB, Stemhagen A, Fraumeni JF Jr. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Res. 1988 Jun 1;48(11):3282-7.
Background: PubMed 17035381Chang ET, Adami HO. The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol Biomarkers Prev. 2006 Oct;15(10):1765-77. doi: 10.1158/1055-9965.EPI-06-0353.
Background: PubMed 12450726Klein G. Nasopharyngeal carcinoma (NPC) is an enigmatic tumor. Semin Cancer Biol. 2002 Dec;12(6):415-8. doi: 10.1016/s1044579x02000834. No abstract available.
Background: PubMed 4842361Buell P. The effect of migration on the risk of nasopharyngeal cancer among Chinese. Cancer Res. 1974 May;34(5):1189-91. No abstract available.
Background: PubMed 16585867Ozer E, Grecula JC, Agrawal A, Rhoades CA, Young DC, Schuller DE. Long-term results of a multimodal intensification regimen for previously untreated advanced resectable squamous cell cancer of the oral cavity, oropharynx, or hypopharynx. Laryngoscope. 2006 Apr;116(4):607-12. doi: 10.1097/01.mlg.0000208340.42071.f9.
Background: PubMed 16683383Fallai C, Bolner A, Signor M, Gava A, Franchin G, Ponticelli P, Taino R, Rossi F, Ardizzoia A, Oggionni M, Crispino S, Olmi P. Long-term results of conventional radiotherapy versus accelerated hyperfractionated radiotherapy versus concomitant radiotherapy and chemotherapy in locoregionally advanced carcinoma of the oropharynx. Tumori. 2006 Jan-Feb;92(1):41-54. doi: 10.1177/030089160609200108.
Background: PubMed 21684027Blanchard P, Baujat B, Holostenco V, Bourredjem A, Baey C, Bourhis J, Pignon JP; MACH-CH Collaborative group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol. 2011 Jul;100(1):33-40. doi: 10.1016/j.radonc.2011.05.036. Epub 2011 Jun 16.
Background: PubMed 27686945Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.
Background: PubMed 25957714Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.
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.

Jian Guan, Ph.D. contact

+86-13632102247

51643930@qq.com

Jian Guan study chair

Nanfang Hospital, Southern Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: looking for participants now, as of the sponsor's last update on 18 Jun 2023. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jian Guan, Ph.D. (+86-13632102247, 51643930@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure-free survival (time frame: 3-year). 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 NCT03919552, which also lists 15 linked publications.

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 18 Jun 2023.