Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC (NPC)

• ClinicalTrials.gov Identifier: NCT01854203
• Recruitment Status: Unknown
• First Posted: May 15, 2013
• Last Update Posted: July 30, 2013
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Jian-jun Li, Sun Yat-sen University

Tracking Information

• First Submitted Date: May 10, 2013
• First Posted Date: May 15, 2013
• Last Update Posted Date: July 30, 2013
• Study Start Date: July 2013
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 14, 2013)

• Overall survival [ Time Frame: 3-year ]
  Overall survival is calculated from randomization to death from any cause.
• Failure-free survival [ Time Frame: 3-year ]
  Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
• Locoregional failure-free survival [ Time Frame: 3-year ]
  the latency to the first local failure
• Distant failure-free survival [ Time Frame: 3-year ]
  The latency to the first remote failure

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 14, 2013): Difference in the complete response rates between the two treatment arms [ Time Frame: 12 weeks after the completion of therapy ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 13, 2013)

Rates of toxicity [ Time Frame: 3-years ]

Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy.

Original Other Pre-specified Outcome Measures (submitted: May 14, 2013)

Rates of toxicity [ Time Frame: 3-years ]

Rates of toxicity will also be compared. Rates will be compared by the chi-square test.

Descriptive Information

• Brief Title: Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
• Official Title: Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
• Brief Summary: Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
• Detailed Description: The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Nasopharyngeal Carcinoma

Intervention

• Drug: Inductive chemotherapy + concurrent cisplatin and IMRT
  Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.
  Other Name: Gemcitabine and cisplatin
• Drug: Inductive chemotherapy + IMRT
  Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
  Other Name: Gemcitabine and cisplatin

Study Arms

• Experimental: IInductive chemotherapy + concurrent cisplatin and IMRT
  Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.
  Intervention: Drug: Inductive chemotherapy + concurrent cisplatin and IMRT
• Experimental: Inductive chemotherapy + IMRT
  Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
  Intervention: Drug: Inductive chemotherapy + IMRT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 14, 2013): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2016
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
• A Karnofsky performance status of at least 80;
• 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: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
• 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: a creatinine clearance rate of at least 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 >65 years or <18 years.
• Distant metastasis,
• Treatment with palliative intent.
• Pregnancy or lactation.
• a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
• history of renal disease, unstable cardiac disease requiring treatment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01854203
• Other Study ID Numbers: ChiECRCT-2013003
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jian-jun Li, Sun Yat-sen University
• Study Sponsor: Sun Yat-sen University
• Collaborators: Not Provided

Investigators

• Study Director: yong Su, M.D.; Sun Yat-sen University
• Principal Investigator: Janjun Li, M.D.; Sun Yat-sen University
• Principal Investigator: Lizhi Liu, M.D.; Sun Yat-sen University

• PRS Account: Sun Yat-sen University
• Verification Date: July 2013