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Nasopharyngeal CarcinomaPhase 3NCT00677118

Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

A Phase 3 study testing Cisplatin,fluorouracil and Cisplatin 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Cisplatin,fluorouracil and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
506 participants
Where
1 siteChina
Study dates
Jun 2006to Mar 2015
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
  • Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
  • No evidence of distant metastasis (M0)
  • Performance status: KPS ≥70
  • With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
  • Renal: creatinine clearance ≥60ml/min
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
  • Written informed consent

Who cannot join

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age ≥70 or <18
  • With a history of renal disease
  • Prior malignancy
  • Previous chemotherapy or radiotherapy
  • Patient is pregnant or lactating
  • Unstable cardiac disease requiring treatment.
  • Emotion disturbance

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.

Read the detailed description

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.

Being tested
Cisplatin,fluorouracil, Cisplatin
Keywords
Nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Adjuvant chemotherapy, Clinical trial
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,fluorouracilDrug

    Also called Cisplatin and fluorouracil

    Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.

  • CisplatinDrug

    Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.

Study groups in NCT00677118
Study groupRoleWhat they receive
Concurrent and adjuvantExperimentalConcurrent chemoradiotherapy plus adjuvant chemotherapy
Receives: Drug: Cisplatin,fluorouracil
ConcurrentActive comparatorConcurrent chemoradiotherapy
Receives: Drug: Cisplatin

What is being measured

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

  1. Failure-free survival

    Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

    Measured: 2-yr

Secondary outcomes (1)

  1. Overall survival, distant failure-free survival and locoregional failure-free survival

    Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.

    Measured: 2-yr

Timeline

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

  1. First posted13 May 2008 (estimated)
  2. Study startJun 2006
  3. Primary completionMar 2015 (estimated)
  4. Study completionMar 2015 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
506 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00677118
Sponsor's protocol ID
YP2008004
Status last verified
Mar 2010
First submitted
9 May 2008
Last updated
12 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Chua DT, Sham JS, Kwong DL, Au GK. Treatment outcome after radiotherapy alone for patients with Stage I-II nasopharyngeal carcinoma. Cancer. 2003 Jul 1;98(1):74-80. doi: 10.1002/cncr.11485.

    PubMed 12833458

  • Ma J, Mai HQ, Hong MH, Cui NJ, Lu TX, Lu LX, Mo HY, Min HQ. Is the 1997 AJCC staging system for nasopharyngeal carcinoma prognostically useful for Chinese patient populations? Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1181-9. doi: 10.1016/s0360-3016(01)01537-1.

    PubMed 11483327

  • Zhao C, Han F, Lu LX, Huang SM, Lin CG, Deng XW, Lu TX, Cui NJ. [Intensity modulated radiotherapy for local-regional advanced nasopharyngeal carcinoma]. Ai Zheng. 2004 Nov;23(11 Suppl):1532-7. Chinese.

    PubMed 15566674

  • Lee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22. doi: 10.1016/s0360-3016(02)02724-4.

    PubMed 12007936

  • Kam MK, Teo PM, Chau RM, Cheung KY, Choi PH, Kwan WH, Leung SF, Zee B, Chan AT. Treatment of nasopharyngeal carcinoma with intensity-modulated radiotherapy: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1440-50. doi: 10.1016/j.ijrobp.2004.05.022.

    PubMed 15590175

  • Decker DA, Drelichman A, Al-Sarraf M, Crissman J, Reed ML. Chemotherapy for nasopharyngeal carcinoma. A ten-year experience. Cancer. 1983 Aug 15;52(4):602-5. doi: 10.1002/1097-0142(19830815)52:43.0.co;2-6.

    PubMed 6683121

  • Al-Sarraf M. Chemotherapeutic management of head and neck cancer. Cancer Metastasis Rev. 1987;6(3):181-98. doi: 10.1007/BF00144263.

    PubMed 3319271

  • Rossi A, Molinari R, Boracchi P, Del Vecchio M, Marubini E, Nava M, Morandi L, Zucali R, Pilotti S, Grandi C, et al. Adjuvant chemotherapy with vincristine, cyclophosphamide, and doxorubicin after radiotherapy in local-regional nasopharyngeal cancer: results of a 4-year multicenter randomized study. J Clin Oncol. 1988 Sep;6(9):1401-10. doi: 10.1200/JCO.1988.6.9.1401.

    PubMed 3047335

  • Chi KH, Chang YC, Guo WY, Leung MJ, Shiau CY, Chen SY, Wang LW, Lai YL, Hsu MM, Lian SL, Chang CH, Liu TW, Chin YH, Yen SH, Perng CH, Chen KY. A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1238-44. doi: 10.1016/s0360-3016(01)02781-x.

    PubMed 11955734

  • Frederick L. Greene, David L. Page, Irvin D. Fleming, et al: American Joint Committee on Cancer Staging Manual (ed 6). Philadelphia (PA): Lippincott, 2002.

  • Freedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998.

  • Chow, S.C., Shao, J., Wang, H. Sample Size Calculations in Clinical Research. New York: Marcel Dekker; 2003.

  • 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. Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial. Eur J Cancer. 2017 Apr;75:150-158. doi: 10.1016/j.ejca.2017.01.002. Epub 2017 Feb 22.

    PubMed 28235726

  • 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.

    PubMed 22154591

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin,fluorouracil and Cisplatin 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 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: status not confirmed, as of the sponsor's last update on 12 Jul 2013. 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?

Results are not available in the source record.

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 (time frame: 2-yr). 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 NCT00677118, which also lists 14 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 Jul 2013.

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