Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer
Public ClinicalTrials.gov record NCT01247246. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.
Study identification
- NCT ID
- NCT01247246
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2010
- Primary completion
- May 31, 2014
- Completion
- May 31, 2014
- Last update posted
- May 25, 2014
2010 – 2014
United States locations
- U.S. sites
- 49
- U.S. states
- 31
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Center for Cancer Care | Peoria | Arizona | 85381 | — |
| Arizona Oncology Services Foundation | Phoenix | Arizona | 85013 | — |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 99309 | — |
| Disney Family Cancer Center | Burbank | California | 91505 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| VA Long Beach Health System | Long Beach | California | 90822 | — |
| Pomona Valley Hospital | Pomona | California | 91767 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| The Whittingham Cancer Center, Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Helen F. Graham Cancer Center | Newark | Delaware | 19178 | — |
| Washington Cancer Institute | Washington D.C. | District of Columbia | 20010 | — |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | — |
| Lake County Oncology and Hematology | Tavares | Florida | 32778 | — |
| The University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| St. John's Cancer Center | Anderson | Indiana | 46016 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | — |
| Louisiana State University Health Sciences Center | Shreveport | Louisiana | 71103 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| St. Agnes Hospital | Baltimore | Maryland | 21229 | — |
| Southcoast Hospital Group | Fairhaven | Massachusetts | 02719 | — |
| Gershenson Radiation | Detroit | Michigan | 48201 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| The Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Veterans Administration NJ Health Care System | East Orange | New Jersey | 07018 | — |
| New York Methodist Hospital | Brooklyn | New York | 11215 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Rochester University Medical Center | Rochester | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Summa Health System | Akron | Ohio | 44304 | — |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | — | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Mount Nittany Medical Center | State College | Pennsylvania | 16803 | — |
| Memorial Hospital of Rhode Island Cancer Center | Pawtucket | Rhode Island | 02860 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Cookeville Regional Cancer Center | Cookeville | Tennessee | 38501 | — |
| Kirkland Cancer Center/Jackson Madison County General Hospital | Jackson | Tennessee | 38301 | — |
| Tyler Hematology Oncology | Tyler | Texas | 75701 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Wheeling Hospital | Wheeling | West Virginia | 26003 | — |
| Medical College of Wisconson | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01247246, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 25, 2014 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01247246 live on ClinicalTrials.gov.