Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma - Full Text View

Purpose

The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy using gemcitabine and cisplatin in NPC patients.

Condition	Intervention	Phase
Nasopharyngeal Carcinoma	Drug: Drug: Gemcitabine and cisplatin Drug: Cisplatin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by First People's Hospital of Foshan:

Primary Outcome Measures:

Failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

Secondary Outcome Measures:

Overall survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Overall survival is calculated from randomization to death from any cause.
Locoregional failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
the latency to the first local failure
Distant failure-free survival [ Time Frame: 3-year ] [ Designated as safety issue: No ]
The latency to the first remote failure
The initial response rates after treatments [ Time Frame: 16 weeks after completion of radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Concurrent chemoradiotherapy Patients receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy	Drug: Cisplatin Patients receive radical radiotherapy and cisplatin (40mg/m2) every week for six cycles during radiotherapy Other Name: Cisplatin
Experimental: Inductive and concurrent Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy.	Drug: Drug: Gemcitabine and cisplatin Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy. Other Name: Gemcitabine and cisplatin

Detailed Description:

Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy, Varian), and cisplatin (40mg/m2) every weeks for six cycles during radiotherapy. Radiation is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at 54 Gy in 30 fractions. Patients in the investigational arm receive gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy. The primary end point is response rates after radiotherapy, failure-free survival (FFS) and toxic effects and treatment compliance. Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
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 Stage IVb：Any T、N3.
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.
Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417390

Locations

China, Guangdong
Wei-wei Hong
Foshan, Guangdong, China, 528000

Sponsors and Collaborators

First People's Hospital of Foshan

More Information

Publications:

Xiayun H, Ou D, Ying H, Zhu G, Hu C, Liu T. Experience with combination of cisplatin plus gemcitabine chemotherapy and intensity-modulated radiotherapy for locoregionally advanced nasopharyngeal carcinoma. Eur Arch Otorhinolaryngol. 2011 Jun 26; [Epub ahead of print]

Drössigk U, Hiepe T, Pötzsch F, Scholz D, Tietz HJ. Stimulation of human immunodeficiency virus expression in permanent monocytic cells by Sarcocystis gigantea extract. Parasitol Res. 1998 Jun;84(6):455-8.

Lowy AM, Firdaus I, Roychowdhury D, Redmond K, Howington JA, Sussman JJ, Safa M, Ahmad SA, Reed MF, Rose P, James L, Jazieh AR. A phase II study of sequential neoadjuvant gemcitabine and paclitaxel, radiation therapy with cisplatin and 5-fluorouracil and surgery in locally advanced esophageal carcinoma. Am J Clin Oncol. 2006 Dec;29(6):555-61.

Yau TK, Lee AW, Wong DH, Yeung RM, Chan EW, Ng WT, Tong M, Soong IS. Induction chemotherapy with cisplatin and gemcitabine followed by accelerated radiotherapy and concurrent cisplatin in patients with stage IV(A-B) nasopharyngeal carcinoma. Head Neck. 2006 Oct;28(10):880-7.

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.

Benasso M, Merlano M, Sanguineti G, Corvò R, Numico G, Ricci I, Pallestrini E, Santelli A, Vitale V, Marchetti G, Rosso R. Gemcitabine, cisplatin, and radiation in advanced, unresectable squamous cell carcinoma of the head and neck: a feasibility study. Am J Clin Oncol. 2001 Dec;24(6):618-22.

Responsible Party:	Tao Xu, Foshan head and neck group, First People's Hospital of Foshan
ClinicalTrials.gov Identifier:	NCT01417390 History of Changes
Other Study ID Numbers:	FSHNG-1108
Study First Received:	August 15, 2011
Last Updated:	November 12, 2011
Health Authority:	China: Ethics Committee

Keywords provided by First People's Hospital of Foshan:

Nasopharyngeal Carcinoma

Additional relevant MeSH terms:

Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine

Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013