Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC (NPC)
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ClinicalTrials.gov Identifier: NCT01854203 |
Recruitment Status : Unknown
Verified July 2013 by Jian-jun Li, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : May 15, 2013
Last Update Posted : July 30, 2013
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Condition or disease | Intervention/treatment | Phase |
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Nasopharyngeal Carcinoma | Drug: Inductive chemotherapy + concurrent cisplatin and IMRT Drug: Inductive chemotherapy + IMRT | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma |
Study Start Date : | July 2013 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
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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.
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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 |
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.
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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 |
- 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
- Difference in the complete response rates between the two treatment arms [ Time Frame: 12 weeks after the completion of therapy ]
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854203
Contact: Janjun Li, M.D. | +86+13829745245 | lijj@sysucc.org.cn | |
Contact: Lizhi Liu, M.D. | +86+13660528375 | liulizh@sysucc.org.cn |
China, Guangdong | |
Cancer Center,Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: Jian-jun Li, MD +862087343381 lijj@sysucc.org.cn | |
China | |
State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University | Not yet recruiting |
Guangzhou, China, 510060 | |
Principal Investigator: Jian-jun Li, M.D. | |
Sub-Investigator: Li-zhi Liu, M.D. |
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 |
Responsible Party: | Jian-jun Li, Dr, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01854203 |
Other Study ID Numbers: |
ChiECRCT-2013003 |
First Posted: | May 15, 2013 Key Record Dates |
Last Update Posted: | July 30, 2013 |
Last Verified: | July 2013 |
Cisplatin neoadjuvant chemotherapy intensity-modulated radiation therapy concurrent chemoradiotherapy |
Carcinoma Nasopharyngeal Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases |
Otorhinolaryngologic Diseases Gemcitabine Cisplatin Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |