Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and radiation therapy before surgery works in treating patients with pancreatic cancer that has not spread to other places in the body and can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil, irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and gemcitabine hydrochloride with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. To assess the efficacy, measured as the proportion of R0 resections, of fluorouracil-leucovorin calcium-irinotecan hydrochloride-oxaliplatin (FOLFIRINOX) chemotherapy regimen followed by gemcitabine based chemoradiotherapy when used as preoperative therapy in patients with borderline resectable adenocarcinoma of the pancreas. SECONDARY OBJECTIVES: I. To measure the overall response rate (ORR). II. To evaluate overall survival (OS). III. To evaluate progression free survival (PFS). IV. To evaluate safety and toxicity associated with chemotherapy and radiotherapy. V. To assess adverse events related to surgery. VI. To assess the proportion of patients able to undergo resection. VII. To assess proportion of patients requiring vascular reconstruction. OUTLINE: CHEMOTHERAPY REGIMEN: Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on day 1, and fluorouracil IV over 46 hours on days 1-3. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving disease progression proceed to chemoradiotherapy. CHEMORADIOTHERAPY REGIMEN: Beginning 4-6 weeks after completion of chemotherapy, patients undergo intensity-modulated radiation therapy (IMRT) on 5 consecutive days per week for a total of 28 fractions and receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 30 months.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percentage of Participants Achieving R0 Resection (R0 Resection Rate) [Up to 30 months]. Number, Percentage of Participants (90% Confidence Interval). Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride) (n=18): 55.6 (33.3 to 68.3).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Adverse Events Related to Surgery [Up to 30 months].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Toxicities Associated With Chemotherapy and Radiotherapy [Up to 30 months]. Count Of Participants, Participants. Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride) (n=22): 22.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Up to 60 months]. Median, Months (95% Confidence Interval). Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride) (n=15): 35.1 (18.4 to 78.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Response Rate [Up to 30 months]. Count Of Participants, Participants. Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride) (n=22): 4.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) [From start of treatment to time of progression, assessed up to 60 months]. Median, Months (Standard Error). Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride) (n=15): 34 (9.81).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Patients Able to Undergo Resection [Up to 30 months]. Count Of Participants, Participants. Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride) (n=22): 15.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Vascular Reconstruction [Up to 30 months]. Count Of Participants, Participants. Treatment (FOLFIRINOX, IMRT, and Gemcitabine Hydrochloride) (n=15): 5.