- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05182112
Radiation Therapy (RT) and Chemotherapy for the Treatment of Pancreatic Cancer With Homologous Recombination Deficiency That Has Spread to the Liver
November 2, 2023 updated by: Memorial Sloan Kettering Cancer Center
Phase I Study of Precision CRT for Liver-Dominant Metastatic Pancreatic Cancer With Homologous Recombination Deficiency (PreCISeRT)
The researchers are doing this study to test the combination of radiation therapy (RT) and low dose chemotherapy in people with metastatic pancreatic cancer that has a homologous recombination deficiency (HRD) and has spread to the liver.
The researchers will try to find the highest safe and effective dose of individualized dose-painted RT that can be given to the liver when combined with standard low dose chemotherapy.
The conformal dose painted RT treatment plan will include higher doses of radiation to the areas of the liver where tumors can be seen, and a lower dose to the entire liver.
The study will also look at blood samples from participants to learn why some people may respond to study treatment (whole liver RT in combination with low dose chemotherapy) better than others.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
-
Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (All Protocol Activities)
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (All Protocol Activities)
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center (All protocol activities)
-
Rockville Centre, New York, United States, 11553
- Memorial Sloan Kettering Nassau (All Protocol Activities)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas metastatic to the liver (liver metastases confirmed pathologically or radiographic liver lesions most consistent with metastases in a patient with pathologically proven pancreatic adenocarcinoma)
- Germline or biallelic somatic pathogenic mutations in the core HR genes including BRCA1, BRCA2, PALB2 and ATM genes are required for dose escalating cohort. Pathogenic germline or biallelic somatic alterations in other HR genes including (BAP1, BARD1, BLM, BRIP1, CHEK2, FAM175A, FANCA, FANCC, NBN, RAD50, RAD51, RAD51C, RTEL1) are allowed in the expansion cohort. Confirmation of the required mutations can be from MSK IMPACT or any other approved germline genetic testing for eligibility purposes.
- ≥1 liver lesion(s) measurable on a contrast-enhanced liver CT, MRI or PET/CT performed within 6 weeks prior to study entry. Any tumor location within the liver is allowed
- At least 1 liver metastasis measuring ≤ 7 cm
- Extrahepatic disease outside the liver is permitted if the hepatic disease is judged to be life-limiting (1-2 sites of disease are allowed, including lung and non-regional nodes, up to and including 5 individual lesions)
- Age ≥18
- ECOG 0-2
- Any prior chemotherapy therapy is allowed including prior treatment with platinum containing chemotherapy and irrespective of response to prior therapy
- Prior treatment with FDA-approved or investigational biologics or novel molecularly targeted therapies, including oral or IV formulations, are permitted. Patients must be off prior targeted therapy for at least 14 days or 4 half-lives prior to the initiation of the study treatment
- Use of an effective means of contraception in men and women of child-bearing potential
- Adequate organ and marrow function within 14 days prior to study entry, defined as:
- Absolute neutrophil count (ANC)>1000/mm3
- Hemoglobin >9 gm/dl (Note: The use of transfusion or other intervention to achieve Hgb > 9.0 g/dl is acceptable.)
- Platelets >100,000/mm3
- Serum creatinine <1.5 mg/dl OR creatinine clearance of >50 cc/min
- Total bilirubin < 1.8 mg/dL
- Prothrombin time/INR < 1.7
- Albumin ≥ 28 g/L
- AST and ALT < 3 times ULN
- ALP < 2.5 times ULN
Exclusion Criteria:
- Prior invasive malignancy, except non-melanoma skin cancer, unless disease free for a minimum of 3 years
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- History of underlying liver disease, including but not limited to cirrhosis, hepatitis or hemochromatosis
- History of major liver resection
- Variants of unknown significance (VUS) in core or non-core HR genes will be excluded
Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Clinical ascites.
- Single right kidney. (A single left kidney is allowed)
- Absolute contraindication to cisplatin including severe hypersensitivity
- Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation Therapy (RT) and Chemotherapy
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).
|
Whole liver irradiation (WLI) to a total dose 1800cGy in 10 fractions will be given over 2 weeks with simultaneously integrated boost (SIB) to deliver focal doses of 3600cGy (dose level 1) and 4800cGy (dose level 2) to select gross lesions.
SIBl dose assignment will be according to the dose escalation scheme, with all patients in dose level 1 receiving boost of 3600cGy to select lesions and those in dose level 2 receiving boosts of 4800cGy to select lesions.
At least one lesion will be selected for dose escalation.
Patients will start cisplatin 10 mg/m2 and gemcitabine 600 mg/m2 intravenously q2 weeks for 1 cycle while undergoing simulation and radiation treatment planning procedures.
After completion of CRT, adjuvant cisplatin 25 mg/m2 and gemcitabine 600 mg/m2 q2 weeks will be continued until progression or unacceptable toxicity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
determine the maximum tolerated dose of focal simultaneously integrated boost (SIB)
Time Frame: 1 year
|
we will use a rolling 6 dose-escalation design which allows for accrual of two to six patients concurrently onto a dose level (hence tends to shorten the study conduct timeline) based on the number of patients currently enrolled and evaluable, the number experiencing dose-limiting toxicity (DLT), and the number still at risk of developing a DLT.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marsha Reyngold, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
December 20, 2021
First Submitted That Met QC Criteria
December 20, 2021
First Posted (Actual)
January 10, 2022
Study Record Updates
Last Update Posted (Estimated)
November 3, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Gemcitabine
Other Study ID Numbers
- 21-443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
-
City of Hope Medical CenterRecruitingPancreatic Neoplasms | Pancreatic Cancer | Pancreatic Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | Pancreatic Cancer Resectable | Pancreatic Carcinoma | Pancreatic Cancer Non-resectable | Pancreatic Cancer Stage III | Pancreatic Cancer Stage | Pancreatic Cancer Stage II | Pancreatic Cancer, Adult | Pancreatic... and other conditionsKorea, Republic of, United States, Japan
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Recurrent Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
University of Wisconsin, MadisonCompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
Clinical Trials on Whole liver irradiation (WLI)
-
Medical University InnsbruckMarcel Seiz-Rosenhagen MD, PD; Meinhard Nevinny-Stickel MD, Prof.; Christian... and other collaboratorsUnknownMetastatic Malignant Neoplasm to the Adult BrainAustria
-
Institut du Cancer de Montpellier - Val d'AurelleActive, not recruiting
-
Regione Emilia-RomagnaCompleted
-
Yonsei UniversityRecruiting
-
Danish Breast Cancer Cooperative GroupDanish Cancer Society; Danish Center for Interventional Research in Radiation...Active, not recruitingBreast CarcinomaDenmark
-
Sun Yat-sen UniversityGuilin Medical College; First People's Hoapital of FoshanCompletedNasopharyngeal CarcinomaChina
-
Azienda Ospedaliero-Universitaria CareggiCompletedBreast Cancer | Radiotherapy Side EffectItaly
-
National Cancer Institute, EgyptCompleted
-
Samsung Medical CenterMinistry of Health, Republic of Korea; Korean Radiation Oncology GroupActive, not recruitingBreast NeoplasmKorea, Republic of
-
Ontario Clinical Oncology Group (OCOG)RecruitingBreast Neoplasm Female | Radiotherapy | Cosmetic OutcomeCanada