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NCT00017173 · ClinicalTrials.gov registry record · Phase 2
S0011, Gene Therapy & Surgery Followed by Chemo & RT in Newly Diagnosed Cancer of the Mouth or Throat
A Phase 2 study, sponsored by SWOG Cancer Research Network.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00017173: Clinical Trial Phase 2 study, sponsored by SWOG Cancer Research Network.
NCT00017173 is a Phase 2 study that was terminated before completion, run by SWOG Cancer Research Network. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00017173, a Phase 2 study, was terminated before completion, sponsored by SWOG Cancer Research Network.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy with the p53 gene may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy plus surgery followed by cisplatin and radiation therapy in treating patients who have newly diagnosed resectable stage III or stage IV cancer of the mouth or throat.
Primary Outcome
accrual rate and percentage of patients successfully receiving the required doses of INGN 201
Interventions
- DRUG cisplatin
- PROCEDURE conventional surgery
- RADIATION radiation therapy
- BIOLOGICAL Ad5CMV-p53 gene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2003-02 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
Why NCT00017173 stopped before completion
NCT00017173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00017173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00017173 about?
NCT00017173 is a clinical study titled "S0011, Gene Therapy & Surgery Followed by Chemo & RT in Newly Diagnosed Cancer of the Mouth or Throat". RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemo...
What is the current status of trial NCT00017173?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2003-02. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00017173?
The interventions under investigation include: cisplatin (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION), Ad5CMV-p53 gene (BIOLOGICAL).
Who is sponsoring clinical trial NCT00017173?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00017173's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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