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Nasopharyngeal CarcinomaPhase 2NCT02871518

Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma

A Phase 2 study testing Cisplatin combine with IMRT in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase II trial to study the effectiveness of two cycles versus three cycles of Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Cisplatin combine with IMRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
1 siteChina
Study dates
Aug 2016to Jul 2021
Phase
Phase 2
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 nasopharyngeal carcinoma, including WHO II or III
  • Original clinical staged as T3-4N0-3 M0 or any T、N2-3M0（according to the 7th AJCC edition）
  • No evidence of distant metastasis (M0)
  • Pretreatment Plasm EB Virus DNA<4000copies/ml
  • Male and no pregnant female
  • Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
Show all 9Show fewer
  • WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
  • With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
  • With normal renal function test (Creatinine ≤ 1.5×ULN)

Who cannot join

  • Patients have evidence of relapse or distant metastasis
  • Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
  • Receiving radiotherapy or chemotherapy previously
  • The presence of uncontrolled life-threatening illness
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  • Receiving other ways of anti-cancer therapy.
  • Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.

Trial locations and contacts

1 site in 1 country.

Lin-Quan Tang, MD,PHD contact

8602087343643

tanglq@sysucc.org.cn

China1 site, 1 recruiting

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Haiqiang Mai, MD,Ph.D, 86-20-8734-3643, maihq@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized Phase II Non-inferiority Study of Two Cycles Versus Three Cycles of Cisplatin Based Concurrent Chemoradiotherapy for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma Based on Pretreatment Plasma EBV DNA Level

This is a Phase II trial to study the effectiveness of two cycles versus three cycles of Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.

Read the detailed description

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Concurrently, although cisplatin-based concurrent chemoradiotherapy was considered as the standard regimen for locoregionally advanced nasopharyngeal carcinoma, several prospective randomized trials have demonstrated that only 52-63% patients can finished three cycles cisplatin-based concurrent chemoradiotherapy( DDP, 100mg/m2,D1,D22 and D43), due to chemoradiotherapy induced toxicity. Combined analyses of NPC-9901 and NPC-9902 Trials indicated that the 5-year locoregional failure free survival was insignificant between the patients received between two and three cycles cisplatin-based concurrent chemoradiotherapy. Our previous studies have also demonstrated that the five years overall survival, distant metastasis free survival and 5-year locoregional failure free survival was not observed significant difference between the patients received between two and three cycles cisplatin-based concurrent chemotherapy. It indicated that one pressing questions remain to be resolved: can we define the optimal dose so that we can reduce toxicity by avoiding unnecessary overdose or an ineffective phase of treatment? Recently, the quantification of pretreatment plasma Epstein-Barr virus (EBV) DNA, which was considered the most potential biomarker to compliment TNM stage, was demonstrated a useful biomarker for the risk stratification, monitoring and prediction of the prognosis of NPC. The investigators previous study demonstrated that for local and regionally advanced NPC patients with EBV DNA <4,000copies/mL, the 3-year's PFS and DMFS was approximate to 90%. Pretreatment plasma EBV DNA levels might be applied to guide concurrent chemotherapy regimen for local and regionally advanced NPC patients. Therefore, the investigators make a hypothesis that the low risk locoregionally advanced NPC patients received two cycles of chemotherapy may gain similar long-term survival as those received three cycles of chemotherapy, leading to less chemotherapy induced toxicity. Therefore, this phase II non-inferiority, randomised controlled clinical trial was designed to assess efficacy for low-risk patients, identified with pretreatment plasma EBV DNA <4,000 copies/mL, received two cycle cisplatin-based chemotherapy compared with three cycle cisplatin-based chemotherapy

Being tested
Cisplatin combine with 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.

  • Cisplatin combine with IMRTDrug

    Also called DDP

    Concurrent cisplatin (100mg/m2，D1,D22) combine with IMRT

  • Cisplatin combine with IMRTDrug

    Also called DDP

    Concurrent cisplatin (100mg/m2，D1,D22 and D43) combine with IMRT

Study groups in NCT02871518
Study groupRoleWhat they receive
Two cycle CCRTExperimentalConcurrent cisplatin(100mg/m2,D1,D22)combine with IMRT
Receives: Drug: Cisplatin combine with IMRT
Three cycle CCRTActive comparatorConcurrent cisplatin(100mg/m2,D1,D22 and D43)combine with IMRT
Receives: Drug: Cisplatin combine with IMRT

What is being measured

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

  1. Progress-free survival

    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

    Measured: 3 years

Secondary outcomes (8)

  1. The shor-term toxic effects

    The shorterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

    Measured: 3 months

  2. Complete Response (CR)

    CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only

    Measured: after the completion of the chemoradiotherapy treatment (up to 9 weeks)

  3. Overall Survival(OS)

    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

    Measured: 3 years

  4. Locoregional Relapse-Free Survival(LRRFS)

    The LRRFS 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

    Measured: 3 years

  5. Distant Metastasis-Free Survival (DMFS)

    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

    Measured: 3 years

  6. Cost-effectiveness analysis

    The cost (including direct cost drug fees, inspection fees, expenses and nursing cost) and incremental cost-effectiveness ratio was calculated between two arms

    Measured: 3 years

  7. The monitoring of plasma EBV DNA

    The plasma EBV DNA will be detected before treatment ,during treatment (weekly) and during follow up( every 3-6 months)

    Measured: 3 years

  8. Long-term toxicities

    Patients will be monitored for long-term toxicity by standard NIH criteria. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck

    Measured: 3 years

Timeline

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

  1. First posted18 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2021 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871518
Sponsor's protocol ID
cycle of CCRT and NPC
Status last verified
Nov 2016
First submitted
17 Jul 2016
Last updated
10 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Li YC, Li XY, Lan KQ, Cheng H, Chen J, Liu LT, Wen DX, Gu LW, Guo WP, Sun XS, Liu SL, Yang JH, Li SC, Li YF, Long HX, Luo DH, Guo L, Mo HY, Sun R, Guo SS, Wang P, Li LB, Yang Q, Liang YJ, Jia GD, Yan JJ, Zhao C, Chen QY, Li LJ, Mai HQ, Tang LQ. Epstein-Barr virus DNA-guided chemoradiotherapy for patients with low-risk locoregionally advanced nasopharyngeal carcinoma: a secondary 5-year follow-up analysis of an open-label, randomised controlled, phase 2 non-inferiority trial. EClinicalMedicine. 2025 Oct 30;90:103615. doi: 10.1016/j.eclinm.2025.103615. eCollection 2025 Dec.

    PubMed 41245547

  • Li XY, Luo DH, Guo L, Mo HY, Sun R, Guo SS, Liu LT, Yang ZC, Yang JH, Qiu F, Sun XS, Wang P, Liu Q, Li JB, Tang QN, Lin C, Yang Q, Liu SL, Liang YJ, Jia GD, Wen DX, Guo CY, Yan JJ, Zhao C, Chen QY, Tang LQ, Mai HQ. Deintensified Chemoradiotherapy for Pretreatment Epstein-Barr Virus DNA-Selected Low-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II Randomized Noninferiority Trial. J Clin Oncol. 2022 Apr 10;40(11):1163-1173. doi: 10.1200/JCO.21.01467. Epub 2022 Jan 6.

    PubMed 34990291

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin combine with IMRT 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 9 inclusion and 7 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 10 Nov 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Lin-Quan Tang, MD,PHD (8602087343643, tanglq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress-free survival (time frame: 3 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 NCT02871518, 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 10 Nov 2016.

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