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NCT03174275 · ClinicalTrials.gov registry record · Phase 2
Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma
A Phase 2 study of Esophageal Cancer and Oropharynx Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 2
- Study locations
NCT03174275 is a Phase 2 study of Esophageal Cancer and Oropharynx Cancer that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 39 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03174275, a Phase 2 study of Esophageal Cancer and Oropharynx Cancer, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 2
- Study locations
Study Summary
Participants in this study have a type of cancer called squamous cell carcinoma of the head and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This is called locally-advanced SCCHN. These participants are eligible for surgery. Previous research with a similar therapy regimen resulted in high rates of cancer shrinkage, high rates of avoiding radiation and its side effects, high cure rate and good quality of life. Radiation can be very toxic. The purpose on this study is to try to avoid radiation. If the participants are not on this study they would be receiving radiation as it is standard treatment of their cancer. In the last study with a similar regimen, about a third of cancers had a pathologic complete response with the first part of the study. This means that the chemotherapy had killed the cancer. The investigators are trying to improve the regimen further with a goal of increasing this rate of complete response to the first part of therapy. The investigators also hope that by improving results in the first part, that more people will be cured and that long term quality of life (especially speech and swallowing) will be improved, both compared to standard therapies and to the last study. Doctors do not know how this therapy will effect the participants. There is no guarantee that this study will benefit the participants. The prior study used a combination of chemotherapy consisting of carboplatin, paclitaxel and a third targeted anti-cancer drug. In this study the investigators are testing the combination of carboplatin, nano-albumin bound paclitaxel and durvalumab. Nano-albumin bound paclitaxel has been shown to be more active against other types of squamous cancers than regular paclitaxel. It is FDA approved for squamous lung cancer, but experimental for head and neck cancer. Durvalumab is an experimental drug that uses the body's own immune system to fight the cancer. Doctors hope that combining Durvalumab with 2 chemo
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Nab-paclitaxel
- DRUG Durvalumab
- PROCEDURE Surgical resection
Study Locations (2)
North Carolina
- Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill - Chapel Hill
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03174275
The ClinicalTrials.gov registry entry for NCT03174275 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (92% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03174275 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03174275 about?
NCT03174275 is a clinical study titled "Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma". Participants in this study have a type of cancer called squamous cell carcinoma of the head and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This is called locally-advanced SCCHN. These participants are eligible for surgery. Previous research with a similar t...
What is the current status of trial NCT03174275?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2017-12-19. Estimated completion is 2027-02-02.
What conditions does trial NCT03174275 study?
This clinical trial studies the following conditions: Esophageal Cancer, Oropharynx Cancer, Oral Cancer, Carcinoma, Squamous Cell, Larynx Cancer.
What interventions are being tested in trial NCT03174275?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Nab-paclitaxel (DRUG), Durvalumab (DRUG), Surgical resection (PROCEDURE).
Who is sponsoring clinical trial NCT03174275?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03174275 being conducted?
This trial has 2 study locations across North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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