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Nasopharyngeal CarcinomaPhase 2NCT01326559

Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Concurrence With Intensity-modulated Radiotherapy for Local Recurrent Nasopharyngeal Carcinoma (NPC)

A Phase 2 study testing Docetaxel, Cisplatin, 5-FU and Cetuximab in people with Nasopharyngeal Carcinoma, run by Hong Kong Nasopharyngeal Cancer Study Group Limited at 4 sites 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

Study Objective: Primary 1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT). Secondary 1. To determine the overall response rate. 2. 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?
Docetaxel, Cisplatin, 5-FU and Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
4 sitesChina
Study dates
Jun 2010to Mar 2017
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

  • Recurrent T3N0-N1M0 NPC (by AJCC/UICC 6th edition) and at least 1 year from the end of last primary course of radiotherapy
  • Age > 18 to < 70 years
  • Performance status: < 1 by ECOG System (Appendix I)
  • Adequate bone marrow \& renal function
  • Patients having Bilirubin =< 1.5 x ULN, ASAT \& ALST=< 1.5 x ULN, Serum creatinine=< 1.25 x ULN and / or Creatinine clearance >= 60ml/min
  • Patients having WBC >= 3x10e9/L, Neutrophils 1.8x10e9/L, Platelets >= 100 x10e9/L,Hemoglobin >=10g/dL
  • Signed written informed consent
  • Patients must have at least one measurable lesion

Who cannot join

  • Use of investigational agent within the past 28 days
  • Pre-treatment with an anti-EGFR drug
  • Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
  • History of severe pulmonary diseases
  • Active infection or other systemic disease under poor control
  • Uncontrolled chronic neuropathy
Show all 9Show fewer
  • Know grade 3 or 4 allergic reaction to any of the components of the treatment
  • Estimated life expectancy is less than 3 months
  • Pregnancy or breast feeding

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Department of Clinical Oncology, Queen Mary Hospital(QMH), Hong Kong

    Hong Kong

  • Department of Clinical Oncology, Queen Mary Hospital

    Hong Kong

  • Department of Clinical Oncology, Tuen Mun Hospital (TMH), Hong Kong

    Hong Kong

  • Department of Oncology, Princess Margaret Hospital

    Hong Kong

Other trials in China

About this study

Official title: Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)

Study Objective:

Primary

  1. To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT).

Secondary

  1. To determine the overall response rate.
  2. To determine the locoregional and distant control rate
  3. To determine the progression-free survival (PFS)
  4. To determine the overall survival (OS)
  5. To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.
Being tested
Docetaxel, Cisplatin, 5-FU and Cetuximab
Keywords
induction chemotherapy, docetaxel, cisplatin, fluorouracil, cetuximab, intensity-modulated radiotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Docetaxel, Cisplatin, 5-FU and CetuximabDrug

    Induction phase (Weeks 1-9):

    Drug Docetaxel Docetaxel 75 mg/m2 IV, D1 every 3 weeks for 3 cycles

    Drug Cisplatin Cisplatin 75 mg/m2 IV, D1 every 3 weeks for 3 cycles

    Drug Fluorouracil Fluorouracil 750 mg/m2 IV, D1-4 every 3 weeks for 3 cycles

    Concurrent phase (weeks 10-16):

    Drug Docetaxel Docetaxel 15 mg/m2 IV, D1 weekly for 7 weeks (Weeks 10-16)

    Drug Cetuximab Cetuximab 400 mg m2 IV, D1 initial dose, then 250 mg/m2 weekly for 7 week (Weeks 10-16)

    IMRT (60 Gy to GTV or biological dose equivalent): 2 Gy/fraction/day, D1-5 per week, for 6 weeks (Weeks 11-16)

Study groups in NCT01326559
Study groupRoleWhat they receive
Experimental 1ExperimentalInduction chemotherapy using Docetaxel, Cisplatin and 5-FU for week 1 to week 9 and followed by concurrent chemoradiation plus cetuximab from week 10 to week 16
Receives: Drug: Docetaxel, Cisplatin, 5-FU and Cetuximab

What is being measured

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

  1. Complete response rate

    Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.

    Measured: 5 years

Secondary outcomes (4)

  1. Overall response rate

    Defined as the proportion of subjects with best response (confirmed CR or PR) compared to the overall treated group.

    Measured: 5 years

  2. Locoregional and distant control rate

    Defined as the proportion of subjects with no local or nodal progression or recurrence and no distant disease progression or recurrence compared to the overall treated group.

    Measured: 5 years

  3. Progression free survival

    Defined as the time in months from first dose of cetuximab until PD is observed or death occurs due to any cause within 90 days after the last tumour assessment or first cetuximab dose.

    Measured: 5 years

  4. Overall survival

    Defined as the time in months from first dose of cetuximab to the date of death is observed. If subject has not died, the survival time will be censored on the last date the subject was known to be alive.

    Measured: 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 posted31 Mar 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2016
  4. Study completionMar 2017

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01326559
Sponsor's protocol ID
NPC-1001 trial
Status last verified
Aug 2017
First submitted
22 Mar 2011
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Fu KK, Newman H, Phillips TL. Treatment of locally recurrent carcinoma of the nasopharynx. Radiology. 1975 Nov;117(2):425-31. doi: 10.1148/117.2.425.

    PubMed 170644

  • Pryzant RM, Wendt CD, Delclos L, Peters LJ. Re-treatment of nasopharyngeal carcinoma in 53 patients. Int J Radiat Oncol Biol Phys. 1992;22(5):941-7. doi: 10.1016/0360-3016(92)90792-g.

    PubMed 1555986

  • Wang CC. Re-irradiation of recurrent nasopharyngeal carcinoma--treatment techniques and results. Int J Radiat Oncol Biol Phys. 1987 Jul;13(7):953-6. doi: 10.1016/0360-3016(87)90030-7.

    PubMed 3597157

  • Teo PM, Kwan WH, Chan AT, Lee WY, King WW, Mok CO. How successful is high-dose (> or = 60 Gy) reirradiation using mainly external beams in salvaging local failures of nasopharyngeal carcinoma? Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):897-913. doi: 10.1016/s0360-3016(97)00854-7.

    PubMed 9531376

  • Leung TW, Tung SY, Sze WK, Sze WM, Wong VY, Wong CS, O SK. Salvage radiation therapy for locally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1331-8. doi: 10.1016/s0360-3016(00)00776-8.

    PubMed 11121630

  • Poon D, Yap SP, Wong ZW, Cheung YB, Leong SS, Wee J, Tan T, Fong KW, Chua ET, Tan EH. Concurrent chemoradiotherapy in locoregionally recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Aug 1;59(5):1312-8. doi: 10.1016/j.ijrobp.2004.01.037.

    PubMed 15275714

  • Yan JH, Hu YH, Gu XZ. Radiation therapy of recurrent nasopharyngeal carcinoma. Report on 219 patients. Acta Radiol Oncol. 1983;22(1):23-8. doi: 10.3109/02841868309134335.

    PubMed 6305129

  • Lu TX, Mai WY, Teh BS, Zhao C, Han F, Huang Y, Deng XW, Lu LX, Huang SM, Zeng ZF, Lin CG, Lu HH, Chiu JK, Carpenter LS, Grant WH 3rd, Woo SY, Cui NJ, Butler EB. Initial experience using intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):682-7. doi: 10.1016/S0360-3016(03)01508-6.

    PubMed 14967420

  • Chua DT, Sham JS, Leung LH, Au GK. Re-irradiation of nasopharyngeal carcinoma with intensity-modulated radiotherapy. Radiother Oncol. 2005 Dec;77(3):290-4. doi: 10.1016/j.radonc.2005.10.010. Epub 2005 Nov 8.

    PubMed 16289398

  • Chua DT, Sham JS, Au GK. Induction chemotherapy with cisplatin and gemcitabine followed by reirradiation for locally recurrent nasopharyngeal carcinoma. Am J Clin Oncol. 2005 Oct;28(5):464-71. doi: 10.1097/01.coc.0000180389.86104.68.

    PubMed 16199985

  • 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

  • Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.

    PubMed 16467544

  • Nakata E, Hunter N, Mason K, Fan Z, Ang KK, Milas L. C225 antiepidermal growth factor receptor antibody enhances the efficacy of docetaxel chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2004 Jul 15;59(4):1163-73. doi: 10.1016/j.ijrobp.2004.02.050.

    PubMed 15234052

  • Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.

    PubMed 17960013

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Cisplatin, 5-FU and Cetuximab in people with Nasopharyngeal Carcinoma, run by Hong Kong Nasopharyngeal Cancer Study Group Limited at 4 sites 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 9 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

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?

Complete response rate (time frame: 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 NCT01326559, 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 16 Aug 2017.

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