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NCT01711658 · ClinicalTrials.gov registry record · Phase 2
TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
NCT01711658: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT01711658 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 142 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01711658, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
Study Summary
PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the human papillomavirus (HPV).
Primary Outcome
An event for progression-free survival is local, regional, or distant disease progression or death due to any cause. Progression-free survival time is defined as time from randomization to the date of progression/death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of survival times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided. Analysis occurred
Interventions
- DRUG Cisplatin
- DRUG placebo
- RADIATION IMRT
- DRUG Lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2013-03-15 |
| Est. Completion | 2022-09-21 |
| Phase | Phase 2 |
What the finished NCT01711658 record still lists
NCT01711658 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT01711658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01711658 about?
NCT01711658 is a clinical study titled "TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.". PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the human papillomavirus (HPV).
What is the current status of trial NCT01711658?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2013-03-15. Estimated completion is 2022-09-21.
What interventions are being tested in trial NCT01711658?
The interventions under investigation include: Cisplatin (DRUG), placebo (DRUG), IMRT (RADIATION), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT01711658?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01711658's enrollment target sits among peer trials
142 507th of 2000 higher than 1,491 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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