A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
This study is currently recruiting participants.
Verified July 2010 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01171781
First received: July 27, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma
| Condition | Intervention | Phase |
|---|---|---|
|
Nasophayngeal Carcinoma Between Stage II and IVb |
Drug: cisplatin (3 weekly) Drug: cisplatin (weekly) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- progression free survival rate at 3 years [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- objective response rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- toxicity [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 3 weekly CDDP based CCRT
radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin
|
Drug: cisplatin (3 weekly)
radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)
|
|
Experimental: weekly cisplatin based CCRT
radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy
|
Drug: cisplatin (weekly)
radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II ~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 ~2 good organ function (liver, renal, hematologic)
Exclusion Criteria:
- active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171781
Contacts
| Contact: Myung-Ju Ahn, M.D, Ph.D. | 822-3410-3438 | silkahn@skku.edu |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Myung-Ju Ahn, M.D., Ph.D. 822-3410-3438 silkahn@skku.edu | |
| Principal Investigator: Myung-Ju Ahn, M.D., Ph.D. | |
Sponsors and Collaborators
Samsung Medical Center
More Information
No publications provided
| Responsible Party: | Myung-Ju Ahn, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01171781 History of Changes |
| Other Study ID Numbers: | 2009-09-037 |
| Study First Received: | July 27, 2010 |
| Last Updated: | July 27, 2010 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases |
Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013