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Alkylating agents
Proton Therapy + Chemotherapy for Esophageal Cancer
Phase 1
Waitlist Available
Led By John Plastaras, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be >18 years of age
Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
Must not have
Patients with primary tumors exceeding 8 cm in length or 5 cm in width (length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT)
Patients with primary tumors located at or above the carina
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial is testing whether proton therapy given before surgery can help people with esophageal cancer.
Who is the study for?
This trial is for adults over 18 with locally advanced esophageal cancer, specifically adenocarcinoma located below the carina. They must be fit for surgery and have good organ function, not be pregnant or nursing, and agree to use birth control if of childbearing potential. Tumors must not exceed certain sizes.
What is being tested?
The study tests increasing doses of preoperative proton beam radiotherapy combined with chemotherapy drugs Carboplatin and Paclitaxel in patients with esophageal cancer to see how well they tolerate it before surgery.
What are the potential side effects?
Possible side effects include reactions from radiation like skin changes and fatigue, as well as chemotherapy-related issues such as nausea, low blood counts leading to infection risk or bleeding problems, kidney effects, and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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My cancer is a type of esophageal cancer located below the windpipe split.
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My hemoglobin is above 10 g/dL and my kidney function is normal.
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My cancer is at stage IIB to IIIC according to the AJCC 7th edition.
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I can carry out all my usual activities without help.
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I am fit for surgery and my blood, kidney, liver, and lung functions are all adequate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My primary tumor is larger than 8 cm long or 5 cm wide.
Select...
My primary tumor is located in the upper part of my lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal CancerExperimental Treatment3 Interventions
Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
108,474 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
413 Previous Clinical Trials
164,601 Total Patients Enrolled
John Plastaras, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My primary tumor is larger than 8 cm long or 5 cm wide.I am older than 18 years.I can carry out all my usual activities without help.My primary tumor is located in the upper part of my lungs.I have not had any cancer other than skin or thyroid cancer in the last 2 years.My cancer is a type of esophageal cancer located below the windpipe split.My hemoglobin is above 10 g/dL and my kidney function is normal.I am using birth control or am not of child-bearing age due to menopause or hysterectomy.My cancer is at stage IIB to IIIC according to the AJCC 7th edition.I am fit for surgery and my blood, kidney, liver, and lung functions are all adequate.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation of Neoadjuvant Proton Radiotherapy in Esophageal Cancer
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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