Trial record 1 of 1 for:
NCT06132087
PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy
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| ClinicalTrials.gov Identifier: NCT06132087 |
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Recruitment Status :
Recruiting
First Posted : November 15, 2023
Last Update Posted : May 6, 2024
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Sponsor:
University of Southern California
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
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Brief Summary:
This clinical trial tests how well surgical resection after chemotherapy given before surgery to make the tumor smaller (neoadjuvant) works to treat pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) and that cannot be removed by surgery (unresectable). In general, surgery is considered the most effective treatment for pancreatic cancer, especially when the cancer is localized and has not spread to other organs. However, most patients with pancreatic cancer are not candidates for surgical removal because the cancer has grown into or close to nearby arteries, veins, or organs and there is a concern of damaging these nearby structures. Researchers want to find out if surgery after neoadjuvant chemotherapy can be done safely to completely remove the tumor in patients with locally advanced and unresectable pancreatic cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Locally Advanced Pancreatic Adenocarcinoma Stage III Pancreatic Cancer American Joint Committee on Cancer v8 Unresectable Pancreatic Adenocarcinoma | Procedure: Biospecimen Collection Procedure: Computed Tomography Procedure: Distal Pancreatectomy Procedure: Laparoscopy Procedure: Magnetic Resonance Imaging Procedure: Pancreaticoduodenectomy Other: Questionnaire Administration Procedure: Surgical Procedure Procedure: Total Pancreatectomy | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | PROACTIVE Pilot Study: Pancreatic Resection Outcomes in Locally Advanced Pancreatic Cancer Involving Visceral Arteries Treated With Neoadjuvant Chemotherapy |
| Actual Study Start Date : | December 1, 2023 |
| Estimated Primary Completion Date : | December 1, 2027 |
| Estimated Study Completion Date : | December 1, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (surgical resection)
Patients undergo laparoscopy followed by surgical resection with pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy at the discretion of the surgeon within 2-8 weeks following completion of standard of care neoadjuvant chemotherapy regimen. Patients undergo CT and blood sample collection throughout the study and/or MRI during screening. Patients also undergo tissue collection at time of surgical resection on study.
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Procedure: Biospecimen Collection
Undergo blood and tissue sample collection
Other Names:
Procedure: Computed Tomography Undergo CT
Other Names:
Procedure: Distal Pancreatectomy Undergo distal pancreatectomy Procedure: Laparoscopy Undergo laparoscopy
Other Names:
Procedure: Magnetic Resonance Imaging Undergo MRI
Other Names:
Procedure: Pancreaticoduodenectomy Undergo pancreaticoduodenectomy
Other Name: Pancreatoduodenectomy Other: Questionnaire Administration Ancillary studies Procedure: Surgical Procedure Undergo surgical resection
Other Names:
Procedure: Total Pancreatectomy Undergo total pancreatectomy
Other Name: Total Excision of the Pancreas |
Primary Outcome Measures :
- R0 resection rate [ Time Frame: At time of surgery ]Will be defined as the proportion of patients with negative resection margins after undergoing surgery.
Secondary Outcome Measures :
- Overall survival [ Time Frame: Up to 2 years ]Determined from the date of registration to the date of death due to any cause.
- Disease-free survival [ Time Frame: Up to 2 years ]Determined from the date of registration to the date of progression prior to surgery, metastases detected during surgery, recurrence (locoregional and/or distant) after resection, and death due to any cause, whichever occurs first.
- Time to locoregional recurrence [ Time Frame: Up to 2 years ]Determined from the date of registration to the date of locoregional recurrence after resection.
- Time to distant metastases [ Time Frame: Up to 2 years ]Determined from the date of registration to the date of metastases prior to surgery, metastases detected during surgery, or distant recurrence after resection.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic or cytologic proof of pancreatic adenocarcinoma
- Locally advanced, stage III (T4NxM0) and unresectable by National Comprehensive Cancer Network (NCCN) Guidelines prior to perioperative chemotherapy
- Patients must have measurable disease at diagnosis per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- At least 4 cycles of perioperative chemotherapy (gemcitabine [Gem]/nab-paclitaxel or fluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFIRINOX]) received with no evidence of progression on restaging scans per RECIST 1.1
- Age ≥ 18 years
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcl
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) if no biliary stenting has been done or 2.0 x ULN if patient is status post (s/p) biliary stenting or two down trending values
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase [SPGT]) ≤ 2.5 X ULN
- Creatinine (Cr) ≤ 1.5 mg/dL or Cr clearance ≥ 30 mL/min (as estimated by Cockcroft Gault)
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Patient with known distant metastases
- Patients who have not recovered from adverse events of chemotherapy due to agents administered more than 4 weeks earlier
- Patients who have progressed on 2 prior systemic chemotherapy lines or received prior radiotherapy for pancreatic cancer
- Patients may not be receiving any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06132087
Contacts
| Contact: Charlean Ketchens, RN | 323-865-3035 | ketchens_c@med.usc.edu | |
| Contact: Rabia Rehman | 323-865-0460 | Rabia.Rehman@med.usc.edu |
Locations
| United States, California | |
| USC / Norris Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: GI Program Manager 323-865-0451 clinical.trials@med.usc.edu | |
| Contact: Rabia Rehman 323-865-0460 Rabia.Rehman@med.usc.edu | |
| Principal Investigator: Steven R. Grossman, MD | |
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Steven R Grossman, MD | University of Southern California |
| Responsible Party: | University of Southern California |
| ClinicalTrials.gov Identifier: | NCT06132087 |
| Other Study ID Numbers: |
3P-23-5 NCI-2023-09210 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 3P-23-5 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 15, 2023 Key Record Dates |
| Last Update Posted: | May 6, 2024 |
| Last Verified: | May 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
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Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms |
Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pancrelipase Gastrointestinal Agents |