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NCT01749956 · ClinicalTrials.gov registry record · Phase 2
5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer
A Phase 2 study of Rectal Cancer, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 11
- Study locations
NCT01749956: Completed Phase 2 study of Rectal Cancer, sponsored by SCRI Development Innovations.
NCT01749956 is a Phase 2 study of Rectal Cancer that has completed, run by SCRI Development Innovations. The registered enrollment target is 39 participants, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01749956, a Phase 2 study of Rectal Cancer, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this Phase II study will be to investigate the antiangiogenic agent, aflibercept, in combination with chemoradiation as preoperative treatment for patients with stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.
Primary Outcome
The Pathologic Complete Response (pCR) Rate is defined as the number of pathologic complete responders among all patients evaluable for response, including evaluable patients who did not proceed to surgery. A pCR is defined as the absence of any residual abnormality detected in a pathological specimen.
Conditions Studied
Interventions
- RADIATION Radiation
- PROCEDURE Surgery
- DRUG Aflibercept
- DRUG FOLFOX6
Study Locations (11)
Florida
- Florida Cancer Specialists - Fort Myers
- Woodlands Medical Specialists - Pensacola
- Florida Cancer Specialists - St. Petersburg
- Space Coast Cancer Center - Titusville
Tennessee
- Tennessee Oncology - Chattanooga - Chattanooga
- Tennessee Oncology, PLLC - Nashville
Kentucky
- Baptist Hospital East - Louisville
Ohio
- Oncology Hematology Care, Inc. - Cincinnati
Oklahoma
- Oklahoma University - Oklahoma City
South Carolina
- South Carolina Oncology Associates - Columbia
Virginia
- Virginia Cancer Institute - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01749956 record still lists
NCT01749956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 3,166-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Radiation is the first listed.
NCT01749956 lists 11 locations in 7 states (Florida, Tennessee, Kentucky).
Frequently Asked Questions
What is clinical trial NCT01749956 about?
NCT01749956 is a clinical study titled "5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer". The purpose of this Phase II study will be to investigate the antiangiogenic agent, aflibercept, in combination with chemoradiation as preoperative treatment for patients with stage II/III rectal cancer, followed by 4 months of FOLFOX6 plus aflibercept adjuvantly.
What is the current status of trial NCT01749956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2013-01. Estimated completion is 2015-09.
What conditions does trial NCT01749956 study?
This clinical trial studies the following conditions: Rectal Cancer.
What interventions are being tested in trial NCT01749956?
The interventions under investigation include: Radiation (RADIATION), Surgery (PROCEDURE), Aflibercept (DRUG), FOLFOX6 (DRUG).
Who is sponsoring clinical trial NCT01749956?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01749956 being conducted?
This trial has 11 study locations across Florida, Kentucky, Ohio, Oklahoma, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01749956's enrollment target sits among peer trials
39 49th of 70 higher than 21 of 70 other Rectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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