Phase Ⅲ Trial of Adjuvant Chemotherapy in Patients With N2-3 Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03321539

Recruitment Status : Active, not recruiting

First Posted : October 25, 2017

Last Update Posted : May 22, 2023

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Sponsor:

Information provided by (Responsible Party):

Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Study Description

Brief Summary:

To see the effect if a combination of concurrent chemoradiotherapy followed by different adjuvant chemotherapy in treating patients with N2-3 nasopharyngeal carcinoma(NPC).

Condition or disease	Intervention/treatment	Phase
Nasopharyngeal Carcinoma	Drug: CCRT+GP Drug: CCRT+PF	Phase 3

Detailed Description:

This phase Ⅲ trial is studying how well radiation therapy and chemotherapy work in treating patients with newly diagnosed N2-3 nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil or cisplatin and gemcitabine, work in different ways (concurrent chemoradiotherapy followed by different adjuvant chemotherapy) to stop the growth of tumor cells.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	216 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Cancer Center of Guangzhou Medical University The Affiliated Hospital of Guizhou Medical University, Guizhou Cancer Hospital The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase Ⅲ Trial of Concurrent Chemoradiotherapy Followed by Adjuvant Chemotherapy (GP Versus PF) in Patients With N2-3 Nasopharyngeal Carcinoma
Actual Study Start Date :	October 30, 2017
Actual Primary Completion Date :	December 25, 2022
Estimated Study Completion Date :	December 31, 2025

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Nasopharyngeal Carcinoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: CCRT+GP Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during radiotherapy followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21days for three cycles	Drug: CCRT+GP Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21 days for three cycles 4 weeks after radiotherapy. Other Name: Adjuvant GP
Active Comparator: CCRT+PF Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during radiotherapy followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles	Drug: CCRT+PF Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles 4 weeks after radiotherapy. Other Name: Adjuvant PF

Outcome Measures

Primary Outcome Measures :

Progress-free survival(PFS) [ Time Frame: 3 years ]
Progress-free survival 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.

Secondary Outcome Measures :

Overall survival(OS) [ Time Frame: 3 years ]
The OS 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.
Locoregional failure-free survival(LRRFS) [ Time Frame: 3 years ]
The LRFS 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.
Distant metastasis-free survival(DMFS) [ Time Frame: 3 years ]
The DMFS 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.
Overall response rate [ Time Frame: 16 weeks after completion of concurrent chemoradiotherapy ]
Tumour response was classified according to RECIST, version 1.1
Incidence of acute and late toxicity [ Time Frame: 3 years ]
Incidence of acute toxicity 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Original clinical staged as any T、N2-3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）
No evidence of distant metastasis (M0).
Age 18-65 years old.
ECOG Performance status less or equal to 1.
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.

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age <18 or >65 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321539

Locations

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China, Guangdong
Department of Radiation Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou,, Guangdong, China, 510000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China, Guizhou
The Affiliated Hospital of Guizhou Medical University, Guizhou Cancer Hospital
Guiyang, Guizhou, China, 550000
China, Hunan
The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital
Changsha, Hunan, China, 410000

Sponsors and Collaborators

Sun Yat-sen University

Investigators

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Principal Investigator:	Hai-Qiang Mai, MD,PhD	Sun Yat-sen University

More Information

Publications of Results:

Ribassin-Majed L, Marguet S, Lee AWM, Ng WT, Ma J, Chan ATC, Huang PY, Zhu G, Chua DTT, Chen Y, Mai HQ, Kwong DLW, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Bourhis J, Pignon JP, Blanchard P. What Is the Best Treatment of Locally Advanced Nasopharyngeal Carcinoma? An Individual Patient Data Network Meta-Analysis. J Clin Oncol. 2017 Feb 10;35(5):498-505. doi: 10.1200/JCO.2016.67.4119. Epub 2016 Dec 5.

Other Publications:

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.

Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23. Erratum In: Lancet. 2016 Oct 15;388(10054):1882.

Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. doi: 10.1016/S1470-2045(11)70320-5. Epub 2011 Dec 7.

Twu CW, Wang WY, Chen CC, Liang KL, Jiang RS, Wu CT, Shih YT, Lin PJ, Liu YC, Lin JC. Metronomic adjuvant chemotherapy improves treatment outcome in nasopharyngeal carcinoma patients with postradiation persistently detectable plasma Epstein-Barr virus deoxyribonucleic acid. Int J Radiat Oncol Biol Phys. 2014 May 1;89(1):21-9. doi: 10.1016/j.ijrobp.2014.01.052.

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Responsible Party:	Hai-Qiang Mai,MD,PhD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT03321539
Other Study ID Numbers:	2017-FXY-077
First Posted:	October 25, 2017 Key Record Dates
Last Update Posted:	May 22, 2023
Last Verified:	May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Hai-Qiang Mai,MD,PhD, Sun Yat-sen University:


Nasopharyngeal carcinoma;adjuvant chemotherapy

Additional relevant MeSH terms:

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Carcinoma Nasopharyngeal Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms	Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases

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