Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasopharyngeal Carcinoma | Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation: Intensity Modulated Radiation Therapy (IMRT) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 73 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC). |
Estimated Study Start Date : | June 2019 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | September 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental group
Drug: Endostar Drug: Cisplatin Drug: Docetaxel Radiation
|
Drug: Endostar
Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
Other Name: Recombinant human endostatin injection
Drug: Cisplatin Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
Drug: Docetaxel Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
Radiation: Intensity Modulated Radiation Therapy (IMRT) IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
|
Control group
Drug: Cisplatin Drug: Docetaxel Radiation
|
Drug: Cisplatin
Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
Drug: Docetaxel Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
Radiation: Intensity Modulated Radiation Therapy (IMRT) IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xia He, M.D., Ph.D. | 8625-83283597 | hexia206@163.com | |
Contact: Juying Liu, M.D., Ph.D. | 8625-83283596 | peteadam@yeah.net |
Principal Investigator: | Xia He, M.D., Ph.D. | Jiangsu Cancer Institute & Hospital |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | November 22, 2017 | ||||||||
First Posted Date ICMJE | April 30, 2019 | ||||||||
Last Update Posted Date | April 30, 2019 | ||||||||
Estimated Study Start Date ICMJE | June 2019 | ||||||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
progression-free survival (PFS) [ Time Frame: Approximately 36 months ] Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
|
||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma | ||||||||
Official Title ICMJE | Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC). | ||||||||
Brief Summary | Endostar Continuous Intravenous Infusion Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma. | ||||||||
Detailed Description | This study was a multicenter, prospective, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. A total of 73 patients with pathologically confirmed locoregionally advanced nasopharyngeal carcinoma would be enrolled. Patients were randomly divided into two groups, with 48 patients in the combination group and 25 patients in the control group. The combination group was treated with Induction and Concurrent Chemoradiotherapy combined with Endostar. The control group was treated with Induction and Concurrent Chemoradiotherapy. The short term efficacy and side effects of these treatments would be evaluated. The 1-year, 3-year progression-free survival and overall survival would be analyzed. This data of this study might provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with higher efficacy and low toxicity. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Nasopharyngeal Carcinoma | ||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
73 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 2023 | ||||||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03932266 | ||||||||
Other Study ID Numbers ICMJE | Endo-Naso-001 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Dr. Xia He, Jiangsu Cancer Institute & Hospital | ||||||||
Study Sponsor ICMJE | Jiangsu Cancer Institute & Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Jiangsu Cancer Institute & Hospital | ||||||||
Verification Date | April 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |