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Nasopharyngeal NeoplasmsPhase 3NCT01528618

Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma

A Phase 3 study testing gemcitabine and cisplatin and 5-Fluorouracil and cisplatin in people with Nasopharyngeal Neoplasms, 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 present study will be a randomized, control, multicenter phase III study of recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasopharyngeal Neoplasms
What is being tested?
gemcitabine and cisplatin and 5-Fluorouracil and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
362 participants
Where
1 siteChina
Study dates
21 Feb 2012to 20 Dec 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven NPC diagnosis
  • Elder than 18 years old are inclusive
  • Recurrence or metastatic nasopharyngeal carcinoma with evidence of unsuitable for local treatment
  • Amenable to regular follow-up
  • Subjects with at least one measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable).
  • Performance status: 0-1(ECOG)
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  • WBC > 4.0X109/L, PLT > 100X109/L, with normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and bilirubin < 1.5 x upper limit of normal), with normal renal function (Creatinine < 1.5 x upper limit of normal)
  • No chemotherapy or radical radiotherapy received within 6 months prior to enrollment
  • Life expectancy over twelve weeks
  • Signed and dated informed consent before the start of specific protocol procedures
  • Ability to comply with trial requirements.

Who cannot join

  • Patient suitable for local treatment (eg. radiotherapy)
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Patient with central nervous system metastasis
  • Patient life threatening medical condition
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
  • Performance status ≥ 2
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  • With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTC] grade ≥ 2)
  • Serious concurrent illness
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors[Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry.
  • Patient refusing participation

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

The present study will be a randomized, control, multicenter phase III study of recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.

Read the detailed description

Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in southern and southeastern China ,where the incidence rate has been documented between 10 and 150 cases per 100,000 population per year. NPC is a radiosensitive tumor, and radiotherapy is considered to be the treatment of choice for most cases. The 5-year survival rate (all stages) is around 50% .In other words, more than half of the NPC cases will eventually fail radiotherapy and reasons of the failure are both local relapse and remote metastasis.

For these advanced or metastatic NPC, chemotherapy is the most important therapeutics,and they are relatively responsive to chemotherapy compared to other head and neck cancers. The backbone of the treatment for recurrent/metastatic (R/M) NPC is cisplatin containing regimen, which is also regarded as the standard regimen for other squamous cell carcinoma of head and neck (SCCHN). The FP regimen is widely used in R/M NPC patients now and its response rate is around 40%-65%,but the response period is usually short and the adverse reaction is frequent and badly tolerant, which influent the treatment compliance seriously. What's more, the catheters and pumps are necessary for continuous infusion of 5-Fluorouracil, which add to the cost, immobility and inconvenience of the treatment.

Preclinical and clinical data show synergistic activity between gemcitabine and cisplatin without overlapping toxicity. Several clinical trials enrolling a minority of advanced NPC patients suggest GP regimen has promising effectiveness and well tolerated side effects, and they indicated a potential possibility that the GP regimen comes to the standard first line choice instead of the FP regimen

Being tested
gemcitabine and cisplatin, 5-Fluorouracil and cisplatin
Keywords
Advanced Nasopharyngeal Carcinoma, treatment
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

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

  • gemcitabine and cisplatinDrug

    Also called GP

    The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1 only

  • 5-Fluorouracil and cisplatinDrug

    Also called FP

    The FP regimen consists of 5-Fluorouracil 1,000 mg/m2/day which was administered as a continuous intravenous infusion for 96 hours after completion of the cisplatin on days 1( 80 mg/m2 i.v. infusion for 4 h)

Study groups in NCT01528618
Study groupRoleWhat they receive
gemcitabine and cisplatinExperimentalgemcitabine 1,000 mg/m2 over 30 to 60 minutes on days 1, 8, and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
Receives: Drug: gemcitabine and cisplatin
5-Fluorouracil and cisplatinActive comparator5-Fluorouracil 4,000 mg/m2 CIV over 96 hours and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
Receives: Drug: 5-Fluorouracil and cisplatin

What is being measured

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

  1. Progression free survival (PFS) assessed by independent image committee and the investigators

    Measured: 36 months

Secondary outcomes (3)

  1. Overall survival (OS)

    Measured: 36 months

  2. Objective response rate (ORR)

    Measured: 36 months

  3. Number of Participants with Adverse Events

    Measured: 36 months

Timeline

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

  1. First posted8 Feb 2012 (estimated)
  2. Study start21 Feb 2012
  3. Primary completion10 Apr 2016
  4. Study completion20 Dec 2020

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
Masking
None (open label)
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528618
Sponsor's protocol ID
GEM20110714
Status last verified
Sep 2021
First submitted
31 Jan 2012
Last updated
4 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Hong S, Zhang Y, Yu G, Peng P, Peng J, Jia J, Wu X, Huang Y, Yang Y, Lin Q, Xi X, 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, Fang W, Zhang L. Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study. J Clin Oncol. 2021 Oct 10;39(29):3273-3282. doi: 10.1200/JCO.21.00396. Epub 2021 Aug 11.

    PubMed 34379443

  • 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.

    PubMed 27567279

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine and cisplatin and 5-Fluorouracil and cisplatin in people with Nasopharyngeal Neoplasms, 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 11 inclusion and 10 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 4 Oct 2021. 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?

Progression free survival (PFS) assessed by independent image committee and the investigators (time frame: 36 months). 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 NCT01528618, which also lists 2 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 4 Oct 2021.

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