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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

November 7, 2019

Primary Completion Date

June 2, 2025

Study Completion Date

November 20, 2029

Conditions
Esophagus CancerEsophageal CancerCancer of the Esophagus
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

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
lead

Washington University School of Medicine

OTHER