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Chemotherapy

Intense Radiation + Chemotherapy for Esophageal Cancer

Q: How is the MOS Social Support Measure commonly utilized?

<p>In the case of <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, MOS Social Support Measure is often prescribed. Additionally, this treatment can be beneficial for managing neoplasm metastasis, <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, non-Hodgkin's and other late stage sarcomas.</p>

Phase 1

Recruiting

Led By Gregory Vlacich, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age.

Biopsy-proven carcinoma of the thoracic esophagus, or gastroesophageal junction (GEJ).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 6 month follow-up for all enrolled patients (estimated to be 65 months)

Awards & highlights

Study Summary

This trial is testing whether a more intense form of radiation therapy can improve outcomes for people with inoperable esophageal cancer.

Who is the study for?

This trial is for adults with inoperable esophageal cancer who can't have surgery. They should be able to handle chemoradiation, have a performance status showing they're relatively active (ECOG 0-2), and their blood counts and organ functions need to meet specific criteria. Pregnant or breastfeeding women can't join, nor can those with certain other health issues or recent major surgeries.Check my eligibility

What is being tested?

The study tests if intensifying radiation therapy using an accelerated hypofractionated method along with chemotherapy drugs Carboplatin and Paclitaxel improves outcomes in patients with advanced esophageal cancer. It also includes various assessments like symptom inventories, quality of life questionnaires, social support measures, and optional blood tests for tumor DNA.See study design

What are the potential side effects?

Potential side effects include reactions to the chemotherapy drugs such as nausea, hair loss, numbness in fingers or toes (neuropathy), low blood cell counts leading to increased infection risk or bleeding problems. The intensified radiation may cause more intense side effects at the site of treatment including pain or difficulty swallowing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is in the esophagus or where the stomach meets the esophagus.

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I am scheduled for IMRT photon beam therapy, not 3D CRT or proton therapy.

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I am eligible for and can undergo chemoradiation treatment.

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My esophageal cancer cannot be removed by surgery.

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My liver tests are within the normal range.

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My kidney function is within the normal range according to recent tests.

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My recent blood test shows my bone marrow is working well.

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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 6 month follow-up for all enrolled patients (estimated to be 65 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 6 month follow-up for all enrolled patients (estimated to be 65 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 6 month follow-up for all enrolled patients (estimated to be 65 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) of hypofractionated IMRT with chemotherapy

Secondary outcome measures

Median local relapse-free survival

Median overall survival

Median progression-free survival

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: IMRT + Carboplatin + PaclitaxelExperimental Treatment10 Interventions

Concurrent chemoradiation will consist of hypofractionated intensity modulated radiation therapy (IMRT) with simultaneous integrated boost (SIB) for 3 weeks with carboplatin and paclitaxel for 3 cycles every 7 days. Endoscopy and (optional) PET/CT within 6-8 weeks post-completion of chemoradiation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Intensity Modulated Radiation Therapy

2017

Completed Phase 2

~490

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,786 Total Patients Enrolled

Gregory Vlacich, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

22 Total Patients Enrolled

Shahed N Badiyan, M.D.Principal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04046575 — Phase 1

Esophageal Cancer Research Study Groups: IMRT + Carboplatin + Paclitaxel

Esophageal Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04046575 — Phase 1

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04046575 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide information about previous investigations into the MOS Social Support Measure?

"At the moment, 1175 clinical trials related to MOS Social Support Measure have been launched. Of these, 332 are in their final Phase 3. Though most of them operate from Shanghai itself, 66529 other locations across the globe are also running such studies."

Answered by AI

Is this medical trial currently welcoming new participants?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical study is currently in the process of recruiting participants; it was first posted November 7th 2019 and most recently modified July 6th 2022. This trial needs a total of 20 individuals who can be enrolled at one site."

Answered by AI

How is the MOS Social Support Measure commonly utilized?

"In the case of melanoma, MOS Social Support Measure is often prescribed. Additionally, this treatment can be beneficial for managing neoplasm metastasis, lymphoma, non-Hodgkin's and other late stage sarcomas."

Answered by AI

How secure is the MOS Social Support Measure in helping patients?

"With only a few studies conducted on its safety and efficacy, MOS Social Support Measure was rated a 1 by our team at Power."

Answered by AI

How many participants are taking part in this clinical investigation?

"Affirmative. Clinicaltrials.gov holds evidence that this experiment, posted on November 7th 2019 and most recently refreshed on July 6th 2021, is currently recruiting volunteers. 20 participants need to be sourced from 1 study centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04046575.

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