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Nasopharyngeal CarcinomaPhase 3NCT02940925

TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma

A Phase 3 study testing Drug: Taxol,cisplatin and capecitabine and Drug: Cisplatin and 5-Fluorouracil in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Drug: Taxol,cisplatin and capecitabine and Drug: Cisplatin and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
1 siteChina
Study dates
20 Oct 2016to 31 Aug 2021
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • WHO II or III pathological type
  • stage Ⅳa or Ⅳb (UICC 7th edition)
  • no anticancer treatment before
  • no malignant history
  • both gender, 18-60 years old
  • enough liver function: TBIL≤ULN；AST/ALT≤2.5×ULN；ALP≤5×ULN
Show all 10Show fewer
  • enough kidney function: Clcr≥80 mL/min
  • enough hemo: ANC≥2×109/L, PLT≥100×109/L and HB≥9g/dL
  • no sever heart, lung disfunction
  • PS≤2

Who cannot join

  • previous anticancer treatment
  • distant metastasis
  • pregnant or breasting female
  • can not access to followup
  • enrolled in other therapeutic clinical trial
  • sever infection and internal disease
Show all 11Show fewer
  • sever disfunction of heart, lung, kidney, liver, etc
  • TBIL>ULN；AST/ALT>2.5×ULN；ALP>5×ULN
  • with factors that will affect the administration, distribution,metabolism or evacuation.
  • using immunosuppressive agents after organ transplantation
  • other malignant history

Trial locations and contacts

1 site in 1 country.

China1 site

  • SunYat-senU

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: TPC vs PF as Induction Chemotherapy Combined With CCRT for Stage IVa-b Nasopharyngeal Carcinoma, a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial

The purpose of this study is to compare the survival and toxicity of TPC (TAXOL, DDP AND CAPECITABINE ) VS PF (cisplatin and 5-Fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for stage IVa-b nasopharyngeal carcinoma patients in endemic area.

Read the detailed description

This is a prospective, parallel, randomized, open labeled, multicenter phase III clinical trial to compare the survival and toxicity of TPC VS PF as induction chemotherapy combined with CCRT for stage IVa-b nasopharyngeal carcinoma patients in endemic area.The primary endpoint is failure free survival (FFS）.The secondary endpoints are overall survival(OS）,progression-free survival（PFS）, local-regionally relapse free survival(LRFS), distant metastasis free survival（DMFS)and toxicities.

Being tested
Drug: Taxol,cisplatin and capecitabine, Drug: Cisplatin and 5-Fluorouracil
Keywords
Nasopharyngeal carcinoma, induction chemotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Drug: Taxol,cisplatin and capecitabineOther

    Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

  • Drug: Cisplatin and 5-FluorouracilOther

    Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.

Study groups in NCT02940925
Study groupRoleWhat they receive
Drug: Taxol,cisplatin and capecitabineExperimentalTaxol, cisplatin and capecitabine as induction chemotherapy (IC) combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy |(CCRT).
Receives: Other: Drug: Taxol,cisplatin and capecitabine
Drug: Cisplatin and 5-FluorouracilActive comparatorCisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
Receives: Other: Drug: Cisplatin and 5-Fluorouracil

What is being measured

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

  1. Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause

    Measured: up to 5 years

Secondary outcomes (5)

  1. Overall survival calculated from randomisation to death from any cause

    Measured: up to 5 years

  2. Progression free survival calculated from randomisation to disease progression or death from any cause

    Measured: up to 5 years

  3. Local-regionally relapse free survival calculated from randomisation to locoregional failure

    Measured: up to 5 years

  4. Distant metastasis free survival calculated from randomisation to distant failure

    Measured: up to 5 years

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: up to 5 years

Timeline

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

  1. First posted21 Oct 2016 (estimated)
  2. Study start20 Oct 2016
  3. Primary completion28 Aug 2021
  4. Study completion31 Aug 2021

Resources

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
Model description
Experimental: Drug: Taxol,cisplatin and capecitabine Active Comparator: Drug: Cisplatin and 5-Fluorouracil
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02940925
Sponsor's protocol ID
20160049
Status last verified
Apr 2023
First submitted
21 Sep 2016
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The diagnosis, treatment regimen, toxicity and followup data will be shared once every year through email, phone or meeting.

Publications

  • Hui EP, Ma BB, Leung SF, King AD, Mo F, Kam MK, Yu BK, Chiu SK, Kwan WH, Ho R, Chan I, Ahuja AT, Zee BC, Chan AT. Randomized phase II trial of concurrent cisplatin-radiotherapy with or without neoadjuvant docetaxel and cisplatin in advanced nasopharyngeal carcinoma. J Clin Oncol. 2009 Jan 10;27(2):242-9. doi: 10.1200/JCO.2008.18.1545. Epub 2008 Dec 8.

    PubMed 19064973

  • Chan AT, Ma BB, Lo YM, Leung SF, Kwan WH, Hui EP, Mok TS, Kam M, Chan LS, Chiu SK, Yu KH, Cheung KY, Lai K, Lai M, Mo F, Yeo W, King A, Johnson PJ, Teo PM, Zee B. Phase II study of neoadjuvant carboplatin and paclitaxel followed by radiotherapy and concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma: therapeutic monitoring with plasma Epstein-Barr virus DNA. J Clin Oncol. 2004 Aug 1;22(15):3053-60. doi: 10.1200/JCO.2004.05.178.

    PubMed 15284255

  • Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

    PubMed 17960012

  • Lee AW, Ngan RK, Tung SY, Cheng A, Kwong DL, Lu TX, Chan AT, Chan LL, Yiu H, Ng WT, Wong F, Yuen KT, Yau S, Cheung FY, Chan OS, Choi H, Chappell R. Preliminary results of trial NPC-0501 evaluating the therapeutic gain by changing from concurrent-adjuvant to induction-concurrent chemoradiotherapy, changing from fluorouracil to capecitabine, and changing from conventional to accelerated radiotherapy fractionation in patients with locoregionally advanced nasopharyngeal carcinoma. Cancer. 2015 Apr 15;121(8):1328-38. doi: 10.1002/cncr.29208. Epub 2014 Dec 19.

    PubMed 25529384

  • Gao Y, Huang HQ, Bai B, Cai QC, Wang XX, Cai QQ. Treatment outcome of docetaxel, capecitabine and cisplatin regimen for patients with refractory and relapsed nasopharyngeal carcinoma who failed previous platinum-based chemotherapy. Expert Opin Pharmacother. 2014 Feb;15(2):163-71. doi: 10.1517/14656566.2014.866652. Epub 2013 Dec 3.

    PubMed 24295173

  • Li WZ, Lv SH, He SQ, Lv X, Wang L, Yu YH, Xia WX, Ye YF, Hu D, Bei WX, Lu N, Shi MY, Ke LR, Liang H, Zhang CR, Zhao ZY, Zhang HX, Tong LH, Yang W, Tang WB, Yuan TZ, Guo X, Xie CQ, Liu GY, Xiang YQ. Induction Paclitaxel-Cisplatin-Capecitabine for Nasopharyngeal Carcinoma. NEJM Evid. 2026 Sep;5(9):EVIDoa2500278. doi: 10.1056/EVIDoa2500278. Epub 2026 Aug 25.

    PubMed 42640170

  • Li WZ, Lv X, Hu D, Lv SH, Liu GY, Liang H, Ye YF, Yang W, Zhang HX, Yuan TZ, Wang DS, Lu N, Ke LR, Tang WB, Tong LH, Chen ZJ, Liu T, Cao KJ, Mo HY, Guo L, Zhao C, Chen MY, Chen QY, Huang PY, Sun R, Qiu F, Luo DH, Wang L, Hua YJ, Tang LQ, Qian CN, Mai HQ, Guo X, Xiang YQ, Xia WX. Effect of Induction Chemotherapy With Paclitaxel, Cisplatin, and Capecitabine vs Cisplatin and Fluorouracil on Failure-Free Survival for Patients With Stage IVA to IVB Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):706-714. doi: 10.1001/jamaoncol.2022.0122.

    PubMed 35323856

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug: Taxol,cisplatin and capecitabine and Drug: Cisplatin and 5-Fluorouracil in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 10 inclusion and 11 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: finished, as of the sponsor's last update on 12 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure-free survival calculated from randomisation to locoregional failure, distant failure, or death from any cause (time frame: up to 5 years). 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 NCT02940925, which also lists 7 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 12 Apr 2023.

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