Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
NPC
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2013
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 30, 2013
July 1, 2013
3.4 years
May 10, 2013
July 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Overall survival
Overall survival is calculated from randomization to death from any cause.
3-year
Failure-free survival
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
3-year
Locoregional failure-free survival
the latency to the first local failure
3-year
Distant failure-free survival
The latency to the first remote failure
3-year
Secondary Outcomes (1)
Difference in the complete response rates between the two treatment arms
12 weeks after the completion of therapy
Other Outcomes (1)
Rates of toxicity
3-years
Study Arms (2)
IInductive chemotherapy + concurrent cisplatin and IMRT
EXPERIMENTALPatients 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.
Inductive chemotherapy + IMRT
EXPERIMENTALPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cancer Center,Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University
Guangzhou, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 15, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 30, 2013
Record last verified: 2013-07