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Platinum Complex
Combination Chemotherapy + Radiation for Esophageal Cancer
Phase 2
Recruiting
Led By Theodore S Hong, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤ 1
creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose of protocol therapy until 5 years after the end of protocol therapy
Awards & highlights
Study Summary
This trial is studying how well the study intervention works in combination with the standard of care interventions of FOLFOX, carboplatin paclitaxel, and radiation therapy in treating patients with gastroesophageal junction or esophagogastric cancer.
Who is the study for?
This trial is for adults over 18 with a specific type of esophageal or gastroesophageal junction cancer, confirmed by pathology. They must have an ECOG performance status ≤1 (which means they are fully active or restricted in physically strenuous activity but can do light work), a life expectancy over 3 months, and adequate organ/marrow function. Women who can bear children need a negative pregnancy test and agree to use contraception during the study.Check my eligibility
What is being tested?
The trial tests Liposomal Irinotecan combined with standard treatments: FOLFOX (a chemotherapy regimen), carboplatin, paclitaxel, and radiation therapy on patients with gastroesophageal junction or esophagogastric cancer. The goal is to see how this combination affects their cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to chemotherapy such as nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems; fatigue; hair loss; nerve damage causing numbness or tingling; allergic reactions; and liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
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My kidney function is within the required range.
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My cancer is in the advanced stage and affects the area where my stomach meets my esophagus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose of protocol therapy until 5 years after the end of protocol therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose of protocol therapy until 5 years after the end of protocol therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Complete Response Rate
Secondary outcome measures
Clinical Response
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Overall Survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FOLFOX/ nal-IRIExperimental Treatment4 Interventions
Treatment will be administered on an outpatient basis.
FOLFOX with nal-IRI for eight two-week cycles (16 weeks total)
Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks
Surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Radiation Therapy
2007
N/A
~30
Paclitaxel
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,441 Total Patients Enrolled
IpsenIndustry Sponsor
346 Previous Clinical Trials
73,260 Total Patients Enrolled
Theodore S Hong, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
149 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to certain chemotherapy drugs like 5-fluorouracil, irinotecan, or oxaliplatin.My organs and bone marrow are working well.I am fully active and can carry on all my pre-disease activities without restriction.I have received treatments like chemotherapy or radiation for my esophagogastric cancer.My bilirubin levels are within the normal range or improving if I've had a biliary stent.I am not taking cimetidine but can use other stomach acid reducers.I do not have serious heart, lung problems, recent heart attack, or ongoing infections.I haven't been treated for another cancer with a high risk of coming back in the last 5 years.I had major surgery less than 4 weeks ago and haven't fully recovered.My kidney function is within the required range.You are expected to live for at least 3 more months.I have had fluoropyrimidine treatment before, but not within the last six months unless it was topical.I am not pregnant or breastfeeding.I have a bleeding disorder that is not under control.My scans show cancer has spread beyond its original site.I am allergic to 5-fluorouracil or have a DPD deficiency.My cancer is in the advanced stage and affects the area where my stomach meets my esophagus.I am 18 years old or older.You have a history of seizures or mental health conditions that could impact your ability to understand the study or follow instructions for taking medication.
Research Study Groups:
This trial has the following groups:- Group 1: FOLFOX/ nal-IRI
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the clinical trial currently accommodating?
"Affirmative, the information on clinicaltrials.gov indicates that this research is currently seeking volunteers. The trial was first published on June 29th 2021 and saw its most recent update occur on September 7th 2022. Forty individuals are expected to join from 3 distinct sites."
Answered by AI
What maladies are often addressed using Paclitaxel?
"Paclitaxel is an effective treatment for melanoma, metastatic neoplasms, and non-Hodgkin lymphomas."
Answered by AI
Can you elucidate other attempts to use Paclitaxel in clinical trials?
"Currently, 1174 clinical trials for Paclitaxel are ongoing with 332 of them partaking in Phase 3. Shanghai is hosting several of the studies; however, altogether 66513 medical sites are assessing Paclitaxel's efficacy and safety."
Answered by AI
Is enrollment still open for this clinical research?
"Yes, the available information indicates that this trial is actively recruiting. It was initiated on June 29th 2021 and most recently updated September 7th 2022. Enrollment requires 40 individuals from 3 separate sites."
Answered by AI
Is Paclitaxel a viable treatment option with minimal risks?
"Paclitaxel's safety has been evaluated and received a score of 2, as it is in its second phase of clinical trials. This implies that evidence for the drug's efficacy does not yet exist but there are ongoing studies to assess its safety."
Answered by AI
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