Clinical trial · Observational

The Value of Single-cycle TPF Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Randomized Trial of Comparing One Cycle With Three Cycles Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil in Locoregionally Advanced Nasopharyngeal Carcinoma

NCT02096380CI-TRIAL-00014112unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Two Phase Ⅲ trials (TAX323 and TAX324) showed induction chemotherapy adding docetaxel to cisplatin plus fluorouracil (TPF) could significant improve survival in head and neck cancer, and a Phase Ⅱ trial from Hong Kong by Hui and colleges with this strategy has also been reported in nasopharyngeal carcinoma (NPC). However, whether three cycles induction could delay the whole time of treatment and reduce the survival benefit are still unknown. A retrospective study of one cycle TPF induction chemotherapy by the investigators group (not yet published) could improve survival in NPC. It encourage us to conduct this clinical trial.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Nasopharyngeal Carcinoma	Nasopharyngeal Carcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
One cycle TPF induction chemotherapy for NPC	Drug	—	UNRESOLVED
Three cycles TPF induction chemotherapy for NPC	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
one cycle induction chemotherapy
description
Drug: docetaxel, cisplatin and fluorouracil Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for single one cycle before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy. Other Names: docetaxel, cisplatin and fluorouracil
interventionNames
1. Drug: One cycle TPF induction chemotherapy for NPC
label
three cycles induction chemotherapy
description
Drug: docetaxel, cisplatin and fluorouracil Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for three cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy. Other Names: docetaxel, cisplatin and fluorouracil
interventionNames
1. Drug: Three cycles TPF induction chemotherapy for NPC

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 60 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
* Satisfactory performance status: Karnofsky scale (KPS) \> 70.
* Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0
* Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
* Adequate renal function: creatinine clearance ≥60 ml/min.

Exclusion Criteria:

* Age \>60 years or \<18 years.
* Pregnancy or lactation.
* Treatment with palliative intent.
* Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease including unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control and emotional disturbance.

References

Publications (7)

BACKGROUNDKurita H, Yamamoto E, Nozaki S, Wada S, Furuta I, Miyata M, Kurashina K. Multicenter phase 2 study of induction chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma. Cancer Chemother Pharmacol. 2010 Feb;65(3):503-8. doi: 10.1007/s00280-009-1056-z. Epub 2009 Jul 5. PMID 19579024
BACKGROUNDYoshioka T, Sakayori M, Kato S, Chiba N, Miyazaki S, Nemoto K, Shibata H, Shimodaira H, Ohtsuka K, Kakudo Y, Sakata Y, Ishioka C. Dose escalation study of docetaxel and nedaplatin in patients with relapsed or refractory squamous cell carcinoma of the esophagus pretreated using cisplatin, 5-fluorouracil, and radiation. Int J Clin Oncol. 2006 Dec;11(6):454-60. doi: 10.1007/s10147-006-0610-5. Epub 2006 Dec 25. PMID 17180514
BACKGROUNDJaninis J, Papadakou M, Panagos G, Panousaki A, Georgoulias V, Hatzidaki D, Lefantzis D, Dokianakis G. Sequential chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced head and neck cancer. Am J Clin Oncol. 2001 Jun;24(3):227-31. doi: 10.1097/00000421-200106000-00003. PMID 11404490
BACKGROUNDHui 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. PMID 19064973
BACKGROUNDLorch JH, Goloubeva O, Haddad RI, Cullen K, Sarlis N, Tishler R, Tan M, Fasciano J, Sammartino DE, Posner MR; TAX 324 Study Group. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011 Feb;12(2):153-9. doi: 10.1016/S1470-2045(10)70279-5. Epub 2011 Jan 11. PMID 21233014
BACKGROUNDPosner 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.