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NCT04046575 · ClinicalTrials.gov registry record · Phase 1
Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer
A Phase 1 study of Esophageal Cancer and Esophagus Cancer, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04046575: Active Phase 1 study of Esophageal Cancer and Esophagus Cancer, sponsored by Washington University School of Medicine.
NCT04046575 is a Phase 1 study of Esophageal Cancer and Esophagus Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 12 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046575, a Phase 1 study of Esophageal Cancer and Esophagus Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Rates of local disease control in patients with locally advanced esophageal cancer who are not candidates for surgical resection are suboptimal. Despite treatment with chemotherapy and radiation therapy approximately half of patients will develop recurrence of their cancer at the site of the original primary cancer. Salvage therapy options are largely ineffective and nearly all patients who develop local disease recurrence will succumb to their cancer. Recent clinical trials for lung cancer have demonstrated that local tumor control can be improved safely with accelerated hypofractionated radiation therapy regimens in order to achieve radiation dose intensification. This clinical trial aims to adapt those techniques and assess the safety of such a regimen for the treatment of inoperable thoracic esophageal cancers.
Primary Outcome
The MTD of the combination of radiation and FOLFOX will be estimated using the proposed TITE-CRM model. After the phase I study, the MTD will be chosen as the dose that yields a posterior toxicity estimate closest to 20% while being between 15% and 25%. Toxicity will be coded using CTCAE v5.0.
Conditions Studied
Interventions
- DRUG Carboplatin
- RADIATION Intensity Modulated Radiation Therapy
- OTHER MD Anderson Symptom Inventory (MDASI)-Plus module
- OTHER EuroQol (EQ-5D)
- OTHER SF-12
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2029-11-20 |
| Phase | Phase 1 |
What the registry record for NCT04046575 still lists
NCT04046575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04046575 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04046575 about?
NCT04046575 is a clinical study titled "Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer". Rates of local disease control in patients with locally advanced esophageal cancer who are not candidates for surgical resection are suboptimal. Despite treatment with chemotherapy and radiation therapy approximately half of patients will develop recurrence of their cancer at the site of the origina...
What is the current status of trial NCT04046575?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-11-07. Estimated completion is 2029-11-20.
What conditions does trial NCT04046575 study?
This clinical trial studies the following conditions: Esophageal Cancer, Esophagus Cancer, Cancer of the Esophagus.
What interventions are being tested in trial NCT04046575?
The interventions under investigation include: Carboplatin (DRUG), Intensity Modulated Radiation Therapy (RADIATION), MD Anderson Symptom Inventory (MDASI)-Plus module (OTHER), EuroQol (EQ-5D) (OTHER), SF-12 (OTHER).
Who is sponsoring clinical trial NCT04046575?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04046575 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04046575's enrollment target sits among peer trials
12 118th of 123 higher than 5 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Cancer 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.
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