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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: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01221753 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD
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 |
Why NCT01221753 stopped before completion
NCT01221753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which cetuximab is the first listed.
NCT01221753 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01221753's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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