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NCT01221753 · ClinicalTrials.gov registry record · Phase 2
Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01221753 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 7 participants.
The verdict
NCT01221753, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.
Interventions
- DRUG cetuximab
- DRUG 5-FU
- DRUG cisplatin
- RADIATION IMRT
- DRUG docetaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-07 |
| Est. Completion | 2017-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01221753
The ClinicalTrials.gov registry entry for NCT01221753 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cetuximab is the first listed.
NCT01221753 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01221753 about?
NCT01221753 is a clinical study titled "Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study". In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy...
What is the current status of trial NCT01221753?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2011-07. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01221753?
The interventions under investigation include: cetuximab (DRUG), 5-FU (DRUG), cisplatin (DRUG), IMRT (RADIATION), docetaxel (DRUG).
Who is sponsoring clinical trial NCT01221753?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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