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Chemotherapy

Chemoradiation + Pembrolizumab/Lenvatinib for Esophageal Cancer

Q: Has the FDA cleared Resection for use?

While there is some evidence to support the safety of Resection, it receiving a score of 2 because Phase 2 trials have yet to provide data supporting efficacy.

Q: What maladies does Resection usually address?

Resection, which is the removal of <a href="https://www.withpower.com/clinical-trials/all">all</a> or part of a organ, can be used to try and cure <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>. It is also sometimes recommended for patients with unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> or microsatellite instability high as it may lower the risk of recurrence.

Q: Are new patients currently being accepted into this clinical trial?

That is correct. The listing on clinicaltrials.gov verifies that the trial began recruitment on 1/25/2022 and is still currently looking for patients. There is space for 24 individuals at a single location.

Q: How many individuals are being given this medication as part of the research?

That is accurate. The online information for this clinical trial indicates that it is currently looking for 24 people to participate, at a single location. This study was posted on 1/25/2022 and last updated on 2/16/2022.

Q: What other medical studies have there been on Resection?

As of now, there are 2151 ongoing studies investigating Resection with 436 trials in the third and final Phase. Even though a majority of the research for Resection is taking place in Shanghai, China, there are 93535 locations running clinical trials concerning Resection.

Q: What hypotheses does this trial seek to confirm?

The aim of this medical study, which will last for 14 weeks, is to observe a clinical complete response in patients. Additionally, researchers will be looking at disease-free survival rates, adverse event incidence, and overall survival rates.

Phase 2

Waitlist Available

Led By Joseph Chao

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Radiation defined as external beam radiotherapy with 50.4 Gy

Eastern Cooperative Oncology Group (ECOG) =< 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is studying the effect of giving chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery to treat patients with esophageal or esophageal/gastroesophageal junction cancer that has not spread to other places in the body.

Who is the study for?

Adults with non-metastatic esophageal or gastroesophageal junction cancer suitable for chemoradiation and surgery. Participants must have certain blood cell levels, organ function within specific limits, and agree to use birth control. Excluded are those with recent other treatments, immune conditions, severe allergies to similar drugs, active infections like HIV or hepatitis B/C, pregnant/breastfeeding women, and anyone unlikely to follow the study plan.Check my eligibility

What is being tested?

The trial is testing if a combination of chemoradiation (carboplatin/paclitaxel) and immunotherapy drug pembrolizumab followed by pembrolizumab plus anti-cancer drug lenvatinib before surgery can effectively treat patients. The goal is to see if this regimen kills more tumor cells compared to current standard treatments.See study design

What are the potential side effects?

Possible side effects include reactions from the immune system attacking normal organs due to pembrolizumab; high blood pressure, fatigue from lenvatinib; hair loss, nerve damage from chemotherapy; skin irritation from radiation therapy. Each treatment carries its own risk profile which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have received a specific dose of radiation therapy.

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I am fully active and can carry on all pre-disease activities without restriction.

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My cancer is in the esophagus or where the esophagus meets the stomach and has not spread.

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I am 18 years old or older.

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My cancer is stage I-IVA and is one of the specified types.

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I am receiving carboplatin and paclitaxel on a weekly basis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Clinical complete response (CR)

Pathological complete response (CR)

Secondary outcome measures

Disease

Immune-mediated tumor cytotoxicity

Incidence of adverse events

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemoradiation, pembrolizumab, lenvatinib)Experimental Treatment7 Interventions

CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity. WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity. SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Resection

2021

Completed Phase 2

~410

Carboplatin

2014

Completed Phase 3

~6670

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

Lenvatinib Mesylate

2016

Completed Phase 2

~90

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,457 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,150 Total Patients Enrolled

Joseph ChaoPrincipal InvestigatorCity of Hope Medical Center

5 Previous Clinical Trials

87 Total Patients Enrolled

Media Library

Carboplatin, Paclitaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04929392 — Phase 2

Gastroesophageal Junction Adenocarcinoma Research Study Groups: Treatment (chemoradiation, pembrolizumab, lenvatinib)

Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: Carboplatin, Paclitaxel Highlights & Side Effects. Trial Name: NCT04929392 — Phase 2

Carboplatin, Paclitaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929392 — Phase 2

Frequently Asked Questions

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

Has the FDA cleared Resection for use?

"While there is some evidence to support the safety of Resection, it receiving a score of 2 because Phase 2 trials have yet to provide data supporting efficacy."

Answered by AI

What maladies does Resection usually address?

"Resection, which is the removal of all or part of a organ, can be used to try and cure cancer. It is also sometimes recommended for patients with unresectable melanoma or microsatellite instability high as it may lower the risk of recurrence."

Answered by AI

Are new patients currently being accepted into this clinical trial?

"That is correct. The listing on clinicaltrials.gov verifies that the trial began recruitment on 1/25/2022 and is still currently looking for patients. There is space for 24 individuals at a single location."

Answered by AI

How many individuals are being given this medication as part of the research?

"That is accurate. The online information for this clinical trial indicates that it is currently looking for 24 people to participate, at a single location. This study was posted on 1/25/2022 and last updated on 2/16/2022."

Answered by AI

What other medical studies have there been on Resection?

"As of now, there are 2151 ongoing studies investigating Resection with 436 trials in the third and final Phase. Even though a majority of the research for Resection is taking place in Shanghai, China, there are 93535 locations running clinical trials concerning Resection."

Answered by AI

What hypotheses does this trial seek to confirm?

"The aim of this medical study, which will last for 14 weeks, is to observe a clinical complete response in patients. Additionally, researchers will be looking at disease-free survival rates, adverse event incidence, and overall survival rates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer

2022. "Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for the Treatment of Non-metastatic Esophageal or Esophageal/Gastroesophageal Junction Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04929392.

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