Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT03322995
Brief Summary:
This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.
Detailed Description:
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:
1. response;
2. stable disease;
3. local disease progression;
4. metastatic disease progression.
After the first restaging evaluation, patients who demonstrate:
1. a response will be maintained on the same chemotherapy;
2. stable disease will be changed to a defined alternative chemotherapy or molecular profile-directed therapy;
3. local progression will receive chemoradiation;
4. 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:
NCT03322995
Study Brief:
Protocol Section:
NCT03322995