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Radiation

Chemoradiotherapy for Esophageal Cancer

N/A

Recruiting

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

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

Must have

ECOG performance status ≤ 2

Adequate hematological function: Hemoglobin > 100 g/L, Platelet count > 100x10^9/L, Absolute neutrophil count > 1.5x10^9/L

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to the post-operative visit (60-90 days after surgery)

Awards & highlights

Study Summary

This trial tests if a shorter course of cancer treatment is just as effective as the standard course.

Who is the study for?

This trial is for adults aged 18-75 with biopsy-proven esophageal or gastroesophageal junction adenocarcinoma that's resectable and not spread beyond a certain stage. Participants must be in good enough health to start treatment within a month of consent, have adequate blood counts and organ function, and use effective contraception if capable of childbearing.Check my eligibility

What is being tested?

The study tests hypofractionated radiotherapy combined with chemotherapy before surgery in patients with esophageal cancer. It aims to determine if this less frequent radiation dosing schedule is as effective as the standard approach.See study design

What are the potential side effects?

Potential side effects may include skin reactions at the radiation site, fatigue, difficulty swallowing due to inflammation, nausea from chemotherapy, low blood cell counts increasing infection risk, and potential damage to nearby organs like the lungs.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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My blood counts for hemoglobin, platelets, and neutrophils are within the required range.

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I am between 18 and 75 years old.

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My lung function is good, with an FEV1 of at least 1.5 liters.

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My kidney function is good, with creatinine levels at or below 120 µmol/L.

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I have a confirmed diagnosis of invasive adenocarcinoma of the esophagus or where the stomach meets the esophagus.

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My cancer is in an early stage and hasn't spread to distant parts of my body.

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My liver is functioning well, with normal bilirubin levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to the post-operative visit (60-90 days after surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to the post-operative visit (60-90 days after surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to the post-operative visit (60-90 days after surgery) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine the efficacy of delivering 5-fraction hypofractionated chemoradiotherapy

Secondary outcome measures

Cognitive Therapy

To compare pathological response rates to changes in tumor FDG-PET uptake

To compare pathological response rates to changes in tumor dimensions

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Hypofractionated neoadjuvant concurrent chemoradiotherapyExperimental Treatment1 Intervention

Drug: Carboplatin and Taxol (paclitaxel) Patients will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously for 5 weeks on Days 1,8,15,22 and 29. Radiation: Hypofractionated radiation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated radiotherapy

2015

Completed Phase 3

~510

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,170 Total Patients Enrolled

Media Library

$Hypofractionated radiotherapy (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT05370144 — N/A$

$Esophageal Cancer Research Study Groups: Hypofractionated neoadjuvant concurrent chemoradiotherapy$

$Esophageal Cancer Clinical Trial 2023: Hypofractionated radiotherapy Highlights & Side Effects. Trial Name: NCT05370144 — N/A$

$Hypofractionated radiotherapy (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370144 — N/A$

Frequently Asked Questions

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

What is the total number of participants currently enrolled in this trial?

"Correct. Clinicaltrials.gov affirms that this medical examination, which was initially unveiled on February 8th 2023 is actively searching for participants. Approximately 42 individuals need to be enrolled from 1 location."

Answered by AI

Does this trial admit individuals aged 45 and above as participants?

"This clinical trial can accept participants aged 18-75. Those younger than 18 are eligible for 16 other trials, while those older than 65 have access to 963 different studies."

Answered by AI

Is enrollment in this clinical experiment currently possible?

"Absolutely, the information hosted on clinicaltrials.gov shows that this research endeavour is still active and seeking participants. The trial was first posted on February 8th 2023, with its latest amendment made April 27th of the same year. Currently 42 patients are being sought from one location."

Answered by AI

Who meets the criteria for enrollment in this clinical research project?

"This medical trial is recruiting 42 persons suffering from esophageal cancer, aged between 18 and 75. To be eligible to participate in the study, one must have a biopsy-verified invasive adenocarcinoma of Siewart type I or II; they should not exhibit clinical evidence of metastatic spread (M0) with maximum dimensions for their tumor being 8 cm by 5 cm respectively; possess an ECOG performance status no higher than 2; begin radiation therapy within 30 calendar days after signing consent documents; present hemoglobin levels greater than 100 g/L, platelet count over 100x109/L and absolute neut"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Involving Neoadjuvant Chemoradiotherapy With Hypofractionated Radiotherapy in Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma

2023. "A Study Involving Neoadjuvant Chemoradiotherapy With Hypofractionated Radiotherapy in Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370144.