Chemotherapy after surgery for pancreatic cancer
Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy
PHASE2 · Rutgers, The State University of New Jersey · NCT05415917
This study is testing if extra chemotherapy after surgery for pancreatic cancer can help patients live longer and stay cancer-free compared to just watching and waiting.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT05415917 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of additional chemotherapy with gemcitabine and capecitabine after surgery for pancreatic cancer to the standard approach of surgery followed by observation. Participants will receive chemotherapy every 28 days for six cycles, while the control group will not receive further treatment. The study aims to evaluate disease-free survival and overall survival rates, as well as the safety and quality of life for patients undergoing this treatment. Monitoring will include imaging and laboratory tests to check for disease recurrence over a period of 30 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of pancreatic ductal adenocarcinoma who have undergone neoadjuvant chemotherapy and R0 surgical resection.
Not a fit: Patients who have not undergone neoadjuvant chemotherapy or those with advanced pancreatic cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates for patients with resected pancreatic cancer.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy approaches in pancreatic cancer, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically and/or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma * Neoadjuvant chemotherapy (for at least three months) ± chemoradiation followed by R0 surgical resection * Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2 * At least 18 years of age * Adequate bone marrow and organ functions as defined by: * Absolute neutrophil count ≥ 1000 cells/ μL * Hemoglobin ≥ 8 g/ dL * Platelets \> 75,000 / μL * Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault * Total bilirubin ≤1.5 ULN * AST/ ALT \< 2.5 x ULN, unless with liver metastases and then must be \<5 x ULN of normal * Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately * Ability to understand the nature of this study protocol and give written informed consent. * Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures Exclusion Criteria: * Receipt of any investigational agents at the time of registration * Known, untreated brain metastases * Presence of metastatic disease or malignant ascites on diagnostic imaging * Grade two or greater peripheral neuropathy * Presence of any additional active malignancy within the past 3 years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments * Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure (NYHA classification grade III or IV), unstable angina or active arrhythmia * Major surgery within the 4 weeks prior to initiation of study treatment * A history of allergy or hypersensitivity to any of the study drugs * Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study * Pregnancy * Severe hepatic impairment * Participants with known malabsorption
Where this trial is running
New Brunswick, New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Prateek Gulhati, MD, PhD — Rutgers Cancer Institute of New Jersey
- Study coordinator: Prateek Gulhati, MD, PhD
- Email: pat.gulhati@rutgers.edu
- Phone: 732-235-2465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Cancer, Gemcitabine Chemotherapy, Capecitabine Chemotherapy