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NCT00069953 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT00069953: Completed Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT00069953 is a Phase 2 study that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069953, a Phase 2 study, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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 with radiation therapy may kill more tumor cells PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
Primary Outcome
One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate
Interventions
- DRUG cisplatin
- DRUG paclitaxel
- DRUG fluorouracil
- BIOLOGICAL filgrastim
- BIOLOGICAL pegfilgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2003-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT00069953 record still lists
NCT00069953 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00069953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00069953 about?
NCT00069953 is a clinical study titled "Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction". RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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 with radiation therapy may kill more tumor c...
What is the current status of trial NCT00069953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2003-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00069953?
The interventions under investigation include: cisplatin (DRUG), paclitaxel (DRUG), fluorouracil (DRUG), filgrastim (BIOLOGICAL), pegfilgrastim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00069953?
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 NCT00069953's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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