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Alkylating agents

Radiation + Chemotherapy for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Marsha Reyngold, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed adenocarcinoma of the pancreas metastatic to the liver
ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new way to give radiation and chemotherapy to people with pancreatic cancer that has spread to the liver. The goal is to find the best dose of radiation while minimizing side effects.

Who is the study for?
This trial is for adults with pancreatic cancer that has spread to the liver and shows a specific genetic weakness (HRD). Participants can have had previous chemotherapy, including platinum-based treatments. They must have at least one measurable liver tumor and be in fairly good health overall. Women of childbearing age and men must use contraception.Check my eligibility
What is being tested?
The study tests combining radiation therapy targeting the liver tumors with low dose chemotherapy (Gemcitabine and Cisplatin) in patients. It aims to find the safest high dose of targeted radiation that works well with this chemo regimen, while also studying participants' blood samples to understand treatment response variations.See study design
What are the potential side effects?
Potential side effects include those common to radiation therapy such as fatigue, skin changes, nausea, and potential damage to surrounding organs or tissues; plus chemotherapy-related issues like lowered blood counts leading to infection risk, kidney problems from Cisplatin, hair loss, mouth sores.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pancreatic cancer has spread to my liver.
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I am able to care for myself and move around.
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I have a liver metastasis smaller than 7 cm.
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I have had chemotherapy before, including treatments with platinum.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
determine the maximum tolerated dose of focal simultaneously integrated boost (SIB)

Side effects data

From 2022 Phase 1 & 2 trial • 93 Patients • NCT03684811
46%
Aspartate aminotransferase increased
38%
Nausea
38%
Alanine aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Fatigue
25%
Constipation
25%
Disease Progression
25%
Disease progression
21%
Hyperkalaemia
21%
Diarrhoea
21%
Asthenia
21%
Decreased appetite
17%
Stomatitis
17%
Cough
17%
Red blood cell count decreased
17%
Pruritus
17%
Platelet count decreased
13%
Dyspnoea
13%
Gamma-glutamyltransferase increased
13%
Blood bilirubin increased
13%
Vomiting
13%
Abdominal pain
13%
Pyrexia
13%
Rash
8%
Oedema peripheral
8%
Abdominal pain upper
8%
Neutrophil count decreased
8%
Hyperbilirubinaemia
8%
Hyponatraemia
8%
Headache
8%
Arthralgia
8%
Hypoalbuminaemia
8%
Insomnia
8%
Bronchitis
8%
Lymphocyte count decreased
8%
Weight decreased
8%
Hypophosphataemia
8%
Abdominal distension
8%
Hypokalaemia
4%
Dehydration
4%
Oesophageal varices haemorrhage
4%
Mouth ulceration
4%
Gastrooesophageal reflux disease
4%
White blood cell count decreased
4%
Muscle spasms
4%
Renal failure
4%
Hypercalcaemia
4%
Hypomagnesaemia
4%
Dysgeusia
4%
Ascites
4%
Acute kidney injury
4%
Blood creatinine increased
4%
Pelvic venous thrombosis
4%
Dysphagia
4%
Hepatic enzyme abnormal
4%
Tumour pain
4%
Dyspepsia
4%
Abdominal infection
4%
Hyperglycaemia
4%
Flank pain
4%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 4A
Cohort 5A
Cohort 1A
Cohort 1B
Cohort 2A
Cohort 3A

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiation Therapy (RT) and ChemotherapyExperimental Treatment2 Interventions
Upon enrollment in the study, patients will undergo radiation simulation. Protocol therapy will start upon completion of RT planning (1-2 weeks). Chemoradiation will be initiated 1-2 weeks later depending on RT planning and consist of whole liver irradiation (WLI).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine and Cisplatin
2018
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,621 Total Patients Enrolled
Marsha Reyngold, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
43 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05182112 — Phase 1
Pancreatic Cancer Research Study Groups: Radiation Therapy (RT) and Chemotherapy
Pancreatic Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05182112 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182112 — Phase 1

Frequently Asked Questions

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

What is the current number of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov discloses that the clinical trial is in its active recruitment stage, first posted on December 20th 2021 and most recently updated this same day. The experiment calls for a total of 20 patients to be recruited from 7 locations across the country."

Answered by AI

Has the Food and Drug Administration sanctioned Gemcitabine and Cisplatin for medicinal purposes?

"As a Phase 1 trial, with minimal clinical data to support safety and efficacy, the Gemcitabine-Cisplatin combination scored a 1 on our team's scale of risk."

Answered by AI

Is this investigation still enrolling participants?

"Affirmative. Evidently, clinicaltrials.gov has updated that this research is recruiting participants since its initial posting on December 20th 2021. Currently, the study aims to enrol a total of 20 patients across 7 medical centres."

Answered by AI

Are there any medical facilities conducting this research trial in the city?

"Memorial Sloan Kettering Monmouth (All Protocol Activities) in Middletown, Memorial Sloan Kettering Cancer Center (All protocol activities) in New york, and Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), among other sites, are currently participating in this clinical trial."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Radiation Therapy (RT) and Chemotherapy for the Treatment of Pancreatic Cancer With Homologous Recombination Deficiency That Has Spread to the Liver
2021. "Radiation Therapy (RT) and Chemotherapy for the Treatment of Pancreatic Cancer With Homologous Recombination Deficiency That Has Spread to the Liver". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05182112.
~0 spots leftby Dec 2024
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