Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04046575
PHASE1

Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: Phase I Study of Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2019-11-07

Completion Date

2029-11-20

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

RADIATION

Intensity Modulated Radiation Therapy

-15 fractions of treatment

DRUG

Carboplatin

Begins on day 1 of radiotherapy

OTHER

MD Anderson Symptom Inventory (MDASI)-Plus module

The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

OTHER

EuroQol (EQ-5D)

The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

OTHER

SF-12

The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

OTHER

MOS Social Support Measure

The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

OTHER

CES-D

The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT

PROCEDURE

Blood for ctDNA (optional)

-Collected at pre-treatment, every 2 weeks during chemoradiation, every 2-3 weeks during consolidation chemotherapy, completion of therapy, 6-8 week follow-up, 3 month follow-up, 6 month follow-up, and 12 month follow-up

PROCEDURE

Blood for SCCA

-Collected at pre-treatment, completion of therapy, and 6 month follow-up

DRUG

Paclitaxel

Begins on day 1 of radiotherapy

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States