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NCT01684904 · ClinicalTrials.gov registry record · NA

Proton Therapy for Esophageal Cancer

A NA study of Esophagus Cancer, sponsored by Loma Linda University.

Recruiting
Registry status
NA
Development phase
38
Enrollment target
1
Study location

NCT01684904 is a NA study of Esophagus Cancer that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 38 participants, below the 485-participant average among 11 other Esophagus Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01684904, a NA study of Esophagus Cancer, is actively recruiting participants, sponsored by Loma Linda University.

RECRUITING
Registry status
NA
Development phase
38 participants
Enrollment target
1
Study location

Study Summary

The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil. In designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.

Conditions Studied

Interventions

  • RADIATION Proton radiation

Study Locations (1)

California

  • Loma Linda University Medical Center - Loma Linda

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2013-02-20
Est. Completion 2032-08
Phase NA

Sponsor

Loma Linda University

237 total trials

What the Registry Record Tells You About NCT01684904

The ClinicalTrials.gov registry entry for NCT01684904 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 485-participant average among 11 other Esophagus Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Esophagus Cancer appearing as the primary indexed condition, and to 1 intervention - of which Proton radiation is the first listed.

NCT01684904 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01684904 about?

NCT01684904 is a clinical study titled "Proton Therapy for Esophageal Cancer". The goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have...

What is the current status of trial NCT01684904?

This trial is currently recruiting. It is a NA study. The enrollment target is 38 participants. The study started on 2013-02-20. Estimated completion is 2032-08.

What conditions does trial NCT01684904 study?

This clinical trial studies the following conditions: Esophagus Cancer.

What interventions are being tested in trial NCT01684904?

The interventions under investigation include: Proton radiation (RADIATION).

Who is sponsoring clinical trial NCT01684904?

This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01684904 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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