Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03322995|
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : August 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: First-line Chemotherapy Drug: Second-line Chemotherapy Radiation: Chemoradiation||Phase 2|
Patients will receive standard chemotherapy and chemoradiation for pancreatic cancer. The study intervention is an adaptive approach which modifies systemic therapy based on clinical assessments of treatment response. Treatment response will be assessed by imaging (CT scan), biomarker [serum cancer antigen (CA)19-9] and performance status assessment [short physical performance battery (SPPB) and Center for Epidemiologic Studies Depression Scale (CES-D) evaluations] at the first restaging assessment.
Treatment response will be categorized as:
- stable disease;
- local disease progression;
- metastatic disease progression.
After the first restaging evaluation, patients who demonstrate:
- a response will be maintained on the same chemotherapy;
- stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy;
- local progression will receive chemoradiation;
- metastatic disease will be removed from the trial.
Patients who complete four months of chemotherapy, will be treated with chemoradiation (50.4 Gray (Gy) in 28 fractions). In the absence of local disease progression deemed inoperable, or metastatic disease progression, patients will be offered surgical resection. Patients who did not receive four months of systemic therapy in the neoadjuvant setting will be offered four months of adjuvant therapy at the discretion of their treating physicians.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer|
|Actual Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||August 1, 2024|
Experimental: Restaging: Response to Treatment
After the first restaging evaluation, further treatment will be based on treatment response. Patients who demonstrate a response [decline in carbohydrate antigen 19-9 (CA19-9) values] and radiographic response, along with preserved performance status) will be maintained on the first line chemotherapy for an additional two months.
Drug: First-line Chemotherapy
The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.
Experimental: Restaging: Patients with Stable Disease
Patients who do not have a significant decline in CA19-9 values will be changed to a second-line therapy for an additional two months.
Drug: Second-line Chemotherapy
Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.
Other Name: Gemzar
Experimental: Restaging: Local Disease Progression
After the first restaging evaluation, further treatment will be based on treatment response. If, at the initial restaging, the patient has local disease progression amenable to surgical resection, he or she will receive chemoradiation, rather than continued chemotherapy, so the window of opportunity for surgical resection is not lost.
50.4 Gy in 28 fractions.
- Completion of all intended neoadjuvant therapy and surgical therapy [ Time Frame: Five years. ]This measure is the number of subjects completing all intended neoadjuvant therapy and surgical therapy.
- Overall survival [ Time Frame: Five years ]This measure is the number of subjects alive at the conclusion of the follow-up period.
- Progression-free survival [ Time Frame: Five years ]This measure is the number of subjects achieving complete response, partial response or maintaining stable disease.
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): NCT03322995
|Contact: Medical College of Wisconsin Clinical Cancer Centeremail@example.com|
|United States, Wisconsin|
|Froedtert & the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Froedtert & the Medical College of Wisconsin Clinical Cancer Center 414-805-8900 firstname.lastname@example.org|
|Principal Investigator: Susan Tsai, MD|
|Principal Investigator:||Susan Tsai, MD, MHS||Associate Professor|