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NCT02048020 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel and Carboplatin Before Radiation Therapy With Paclitaxel in Treating HPV-Positive Patients With Stage III-IV Oropharynx, Hypopharynx, or Larynx Cancer
A Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx, sponsored by Jonsson Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT02048020: Completed Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx, sponsored by Jonsson Comprehensive Cancer Center.
NCT02048020 is a Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 26 participants, below the 1,278-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02048020, a Phase 2 study of Human Papillomavirus Infection and Stage III Squamous Cell Carcinoma of the Oropharynx, has completed, sponsored by Jonsson Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving paclitaxel and carboplatin before radiation therapy with paclitaxel may kill more tumor cells.
Primary Outcome
The true 2-year progression-free survival rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression or death 2 years from registration. A 95% confidence interval (CI) for the true progression-free survival rate will be constructed using the Duffy-Santner approach. However, Kaplan-Meier methodology will be used to estimate the final 2-year progression-free survival rate and its 95% CI in case there are censored patients.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG paclitaxel
- RADIATION intensity-modulated radiation therapy
- PROCEDURE quality-of-life assessment
Study Locations (1)
California
- Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-12-26 |
| Est. Completion | 2017-01-09 |
| Phase | Phase 2 |
What the finished NCT02048020 record still lists
NCT02048020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,278-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (98% lower).
The record links to 10 conditions, with Human Papillomavirus Infection appearing as the primary indexed condition, and to 4 interventions - of which carboplatin is the first listed.
NCT02048020 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02048020 about?
NCT02048020 is a clinical study titled "Paclitaxel and Carboplatin Before Radiation Therapy With Paclitaxel in Treating HPV-Positive Patients With Stage III-IV Oropharynx, Hypopharynx, or Larynx Cancer". This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in...
What is the current status of trial NCT02048020?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2013-12-26. Estimated completion is 2017-01-09.
What conditions does trial NCT02048020 study?
This clinical trial studies the following conditions: Human Papillomavirus Infection, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Hypopharynx.
What interventions are being tested in trial NCT02048020?
The interventions under investigation include: carboplatin (DRUG), paclitaxel (DRUG), intensity-modulated radiation therapy (RADIATION), quality-of-life assessment (PROCEDURE).
Who is sponsoring clinical trial NCT02048020?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02048020 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02048020's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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