- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171781
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
July 27, 2010 updated by: Samsung Medical Center
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
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Myung-Ju Ahn, M.D, Ph.D.
- Phone Number: 822-3410-3438
- Email: silkahn@skku.edu
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Recruiting
- Samsung Medical Center
-
Contact:
- Myung-Ju Ahn, M.D., Ph.D.
- Phone Number: 822-3410-3438
- Email: silkahn@skku.edu
-
Principal Investigator:
- Myung-Ju Ahn, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 3 weekly CDDP based CCRT
radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin
|
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
|
radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival rate at 3 years
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life
Time Frame: 36 months
|
36 months
|
objective response rate
Time Frame: 36 months
|
36 months
|
toxicity
Time Frame: 36 months
|
36 months
|
overall survival rate
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
July 27, 2010
First Submitted That Met QC Criteria
July 27, 2010
First Posted (Estimate)
July 28, 2010
Study Record Updates
Last Update Posted (Estimate)
July 28, 2010
Last Update Submitted That Met QC Criteria
July 27, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Cisplatin
Other Study ID Numbers
- 2009-09-037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasophayngeal Carcinoma Between Stage II and IVb
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Hypopharyngeal Carcinoma AJCC v8 | Stage III Laryngeal Cancer AJCC v8 | Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Stage IV Hypopharyngeal Carcinoma AJCC v8 | Stage IV Laryngeal Cancer... and other conditionsUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedTongue Cancer | Salivary Gland Squamous Cell Carcinoma | Stage I Salivary Gland Cancer | Stage I Squamous Cell Carcinoma of the Hypopharynx | Stage I Squamous Cell Carcinoma of the Larynx | Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity | Stage I Squamous Cell Carcinoma of the Nasopharynx and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMucositis | Tongue Cancer | Oral Complications | Recurrent Salivary Gland Cancer | Recurrent Squamous Cell Carcinoma of the Larynx | Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | Recurrent Squamous Cell Carcinoma of the Oropharynx | Recurrent Verrucous Carcinoma of the Larynx | Recurrent... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Caregiver | Salivary Gland Squamous Cell Carcinoma | Malignant Head and Neck Neoplasm | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedHuman Papillomavirus Infection | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage IVC Oropharyngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II Oropharyngeal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingPancreatic Adenocarcinoma | Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Malignant Neoplasm | Recurrent Colorectal Carcinoma | Pancreatic Neuroendocrine Carcinoma | Malignant Head and Neck Neoplasm | Stage III Nasopharyngeal Carcinoma... and other conditionsUnited States
-
Stanford UniversityTerminatedStage IV Nasopharyngeal Carcinoma | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma | Stage II Nasopharyngeal Carcinoma | Stage 0 Nasopharyngeal Carcinoma | Stage 0 Paranasal Sinus Cancer | Stage I Nasopharyngeal Carcinoma | Stage I Paranasal... and other conditionsUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell... and other conditionsUnited States
-
National Cancer Institute (NCI)ExelixisCompletedRecurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Stage I Thyroid Gland Papillary Carcinoma | Stage II Thyroid Gland Papillary Carcinoma | Stage III Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Stage I Thyroid Gland... and other conditionsUnited States
Clinical Trials on cisplatin (3 weekly)
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Korea Cancer Center HospitalCompletedCervical CancersKorea, Republic of
-
Korea Cancer Center HospitalAsan Medical Center; Seoul National University Hospital; Gangnam Severance HospitalRecruitingCervical CancerKorea, Republic of, China, Thailand, Vietnam
-
Northside Clinic, AustraliaTerminated
-
Korea Cancer Center HospitalWithdrawnCervical NeoplasmsKorea, Republic of
-
Barretos Cancer HospitalUnknownRadiotherapy; Complications
-
Mayo ClinicCompleted
-
Seoul National University HospitalUnknownFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Epithelial Ovarian CarcinomaKorea, Republic of
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Japan Clinical Oncology GroupMinistry of Health, Labour and Welfare, JapanTerminated
-
Mei ShiUnknownCervical Cancer | Toxicity Due to RadiotherapyChina