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NCT00002984 · ClinicalTrials.gov registry record · Phase 1
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced or Metastatic Cancer of the Esophagus
A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00002984: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00002984 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00002984, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
RATIONALE: 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 more than on drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with advanced or metastatic cancer of the esophagus.
Primary Outcome
Define the maximum tolerated dose of paclitaxel when given as a 3-hour infusion in combination with cisplatin, 5-FU, and radiation therapy. The MTD will be defined as the dose level immediately below that which caused dose limiting toxicity (DLT) in a third or more of the patients in any cohort.
Interventions
- DRUG cisplatin
- DRUG paclitaxel
- DRUG fluorouracil
- RADIATION radiation therapy
- PROCEDURE surgical procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 1997-03 |
| Est. Completion | 2007-01 |
| Phase | Phase 1 |
What the finished NCT00002984 record still lists
NCT00002984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00002984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00002984 about?
NCT00002984 is a clinical study titled "Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced or Metastatic Cancer of the Esophagus". RATIONALE: 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 more than on drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: ...
What is the current status of trial NCT00002984?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 1997-03. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00002984?
The interventions under investigation include: cisplatin (DRUG), paclitaxel (DRUG), fluorouracil (DRUG), radiation therapy (RADIATION), surgical procedure (PROCEDURE).
Who is sponsoring clinical trial NCT00002984?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00002984's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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