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Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Drug: Gemcitabine and cisplatin
Cisplatin
Sponsored by
First People's Hospital of Foshan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wei-wei HongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Concurrent chemoradiotherapy

Inductive and concurrent

Arm Description

Patients receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy

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.

Outcomes

Primary Outcome Measures

Failure-free survival
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
Overall survival is calculated from randomization to death from any cause.
Locoregional failure-free survival
the latency to the first local failure
Distant failure-free survival
The latency to the first remote failure
The initial response rates after treatments

Full Information

First Posted
August 15, 2011
Last Updated
March 6, 2014
Sponsor
First People's Hospital of Foshan
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1. Study Identification

Unique Protocol Identification Number
NCT01417390
Brief Title
Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title
Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Foshan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent chemoradiotherapy
Arm Type
Experimental
Arm Description
Patients receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy
Arm Title
Inductive and concurrent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Drug: Gemcitabine and cisplatin
Other Intervention Name(s)
Gemcitabine and cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Patients receive radical radiotherapy and cisplatin (40mg/m2) every week for six cycles during radiotherapy
Primary Outcome Measure Information:
Title
Failure-free survival
Description
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Time Frame
3-year
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival is calculated from randomization to death from any cause.
Time Frame
3-year
Title
Locoregional failure-free survival
Description
the latency to the first local failure
Time Frame
3-year
Title
Distant failure-free survival
Description
The latency to the first remote failure
Time Frame
3-year
Title
The initial response rates after treatments
Time Frame
16 weeks after completion of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei wei Hong, M.D.
Phone
+86-757-83162835
Email
wwhong@fsyyy.com
Facility Information:
Facility Name
Wei-wei Hong
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei wei Hong, M.D.
First Name & Middle Initial & Last Name & Degree
Tao Xu, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
21706324
Citation
He X, 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. 2012 Mar;269(3):1027-33. doi: 10.1007/s00405-011-1669-9. Epub 2011 Jun 26. Erratum In: Eur Arch Otorhinolaryngol. 2012 Mar;269(3):1035. Xiayun, He [corrected to He, Xiayun].
Results Reference
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PubMed Identifier
9660134
Citation
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Results Reference
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PubMed Identifier
17148991
Citation
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. doi: 10.1097/01.coc.0000233997.36073.8e.
Results Reference
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PubMed Identifier
16721741
Citation
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. doi: 10.1002/hed.20421.
Results Reference
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PubMed Identifier
16199985
Citation
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.
Results Reference
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PubMed Identifier
11801767
Citation
Benasso M, Merlano M, Sanguineti G, Corvo 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. doi: 10.1097/00000421-200112000-00019.
Results Reference
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Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

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