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

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.

Conditions

• Esophagus Cancer
• Esophageal Cancer
• Cancer 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

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Gregory Vlacich, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-07

Primary Completion

2025-06-02

Completion

2029-11-20

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations