Spots Global Cancer Trial Database for Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas

Study Description

Brief Summary: This prospective cohort, phase II, trial is studying induction chemotherapy combination, FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation concurrent radiotherapy with capecitabine in non-progressed cases, in treating patients with locally advanced cancer pancreas.

Detailed Description: Design \& Methodology: 1. Nature of the study: It is ( prospective cohort study). 2. Study subjects: \*Target Population: Patients, fulfilling the inclusion criteria for the research, will be selected from Assiut clinical oncology department in Assiut University Hospitals. * Sample size: 20 patients. * Characteristics of subjects: * Inclusion criteria: Disease characteristics: * Histological and radiological confirmation of locally advanced cancer pancreas * Inoperable disease * Disease must be able to be encompassed within a radical radiotherapy treatment volume * Not metastatic Patient characteristics: * ECOG performance status 0 or 1 * Life expectancy \> 3 months. * Glomerular filtration rate ≥ 60 mL/min. * WBC \> 3,000/mm³. * Absolute neutrophil count \> 1,500/mm³. * Hemoglobin \> 10.0 g/dL. * Platelet count \> 100,000/mm³. * Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) * Gamma-glutamyl-transferase \< 1.5 times ULN. * Transaminases ≤ 1.5 times ULN. * Bilirubin ≤ 1.5 times ULN. * No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease) * Not pregnant or nursing. * No other previous or current malignant disease likely to interfere with protocol treatment or comparisons * No prior chemotherapy or radiotherapy. 3. Patients \& Methods: Patients are randomized to one treatment arm. Induction 4 times chemotherapy, FOLFIRINOX regimen, consisted of Oxaliplatin at a dose of 85 mg/m2 on day 1 only, administered as a 2-hour intravenous infusion, with the addition, after 30 minutes, of Irinotecan at a dose of 180 mg/m2 on day 1 only given as a 90-minute intravenous infusion. immediately will be followed by Leucovorin at a dose of 200 mg/m2, given as a 2- hour intravenous infusion, day 1 and day 2 This treatment will be followed by fluorouracil (5-FU) dosed at 400 mg/m2, administered as an intravenous bolus on day 1 and day 2, followed by a continuous intravenous infusion of 600 /m2 over a 20- hours period on day 1 and day 2. Treatment will be administered every 2 weeks. G-CSF will be administrated according to the need. In non-progressed cases, induction chemotherapy will be followed by consolidation radiotherapy concurrent with capecitabine 625 mg/m2 BID. Radiotherapy : A fractionated dose of 50.4Gy /28 fraction/15 MeV photon energy generated by Dual-energetic Linear Accelerator. * Gross Target Volume (GTV): visible tumor and lymph nodes. * Clinical Target Volume (CTV): \[tumor/ affected lymph node + 1-2 cm\] + regional lymphatics Lymphatics :corpus: upper and lower pancreaticoduodenal, superior and inferior pancreatic, celiac Head: corpus lymphatics + porta hepatis lymphatics Tail: corpus lymphatics (except pancreaticoduodenal LN) + splenic hilum LN * PTV: CTV + 1-1.5 cm * All patients will undergo a complete classical evaluation at the time of presentation which will be enrolled in a separate sheet for each patient. This will include a detailed history with estimation of the age of onset, the duration of the disease,. * Detailed physical examination will be carried out Treatment evaluation . Laboratory examination include * complete blood count (CBC), * liver function test (LFT) * Renal function test (RFT), * Serum electrolytes at presentation and before each cycle of chemotherapy. Radiographic examination include * Abdominal Multi Detector Computed Tomography (MDCT Abdomen ) * Chest X-ray Before starting treatment, 2 weeks after ending phase 1 of treatment then 4 weeks after ending phase 2 of treatment then every 3 months for 18 months. ● Bone scan will be done in those complaining from bone pain; elevated serum alkaline phosphatase or transaminase level * Quality of life is assessed at baseline, monthly for 6 months, and then at each follow-up visit. After completion of study treatment, patients are followed periodically. Response Assessment : will be carried out, using (RECIST) Response Evaluation Criteria In Solid Tumors, Version 1.1 Chemotherapy Toxicity Assessment: will be carried out, using (CTCAE) Common Terminology Criteria for Adverse Events, Version 4.0 4. Data analysis: Data will be analysed using the computer program, Statistical Package for the Social Science (SPSS V.16). Expected outcomes: The outcome of the study will be compared statistically with previous local and international trails. Ethical considerations: 1. Risk-benefit assessment: There is an acceptable risk may affect the patient in this research study as regard the acceptable side effects of Gemcitabine, Oxaliplatin and radiotherapy. 2. Confidentiality: Any data taken from the patient either from history, the examination or the investigations will be very confidential. 3. Research statement: All patients subjected to this study will be informed about the procedures of the research. 4. Informed consent: The study procedures will be discussed to all patients and consent will be taken from them. 5. Other ethical concerns: The research will be conducted only by scientifically qualified and trained personnel.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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