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NCT01088802 · ClinicalTrials.gov registry record · Phase 2
Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT01088802: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01088802 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01088802, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This research is being done to try to reduce radiation side effects that happen with the standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy are standard treatment for people with squamous cell carcinoma of the oropharynx. The study will look at giving a slightly smaller dose of radiation (de-intensification) to see if regularly expected late toxicities (two years after receiving treatment) can be reduced. This study will also try to see if the smaller dose of radiation is equally effective at treating the cancer and to see if it improves quality of life. Along with this radiation treatment plan some participants in this study will have surgery on their tumor and or receive chemotherapy (cisplatin or carboplatin). The possible surgery and or chemotherapy will be up to the participant's doctor. Study participants will be tested for the Human Papillomavirus (HPV). This tissue test is required for this study. Some studies have suggested that HPV-related cancer is biologically and clinically different as compared to non-HPV-related cancer. Some studies have found that patients with HPV-related oropharynx cancer have a better response to treatment. This test will help researchers learn more about HPV-related cancer.
Primary Outcome
The goal is to achieve a prevalence of \< 15% grade 3+ late toxicity at 2 years; reported as percentage of patients who were free of grade 3+ adverse events (AEs) as measured by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) between 6 months and 24 months. The outcome is reported as percentage of patients who were free of grade 3+ adverse events.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- RADIATION IMRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-03 |
| Est. Completion | 2019-10 |
| Phase | Phase 2 |
What the finished NCT01088802 record still lists
NCT01088802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT01088802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01088802 about?
NCT01088802 is a clinical study titled "Treatment De-Intensification for Squamous Cell Carcinoma of the Oropharynx". This research is being done to try to reduce radiation side effects that happen with the standard radiation methods. Generally surgery, radiation therapy, and sometimes chemotherapy are standard treatment for people with squamous cell carcinoma of the oropharynx. The study will look at giving a sli...
What is the current status of trial NCT01088802?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2010-03. Estimated completion is 2019-10.
What interventions are being tested in trial NCT01088802?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), IMRT (RADIATION).
Who is sponsoring clinical trial NCT01088802?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01088802's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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