Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas
Conditions
Cancer of Pancreas
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Locally advanced pancreatic cancer, Chemotherapy, Radiotherapy
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FOLFIRINOX + CRT
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.

Exclusion Criteria:

- ECOG performance status > 2

- Life expectancy < 3 months.

- Glomerular filtration rate < 30 mL/min.

- Absolute neutrophil count < 1,500/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.

- medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease)

- pregnant or nursing.

- prior chemotherapy or radiotherapy.
Location
Assiut University Hospitals
Asyut, Egypt
Status: Recruiting
Contact: Samir Eid, Professor - samir_eid@hotmail.com
Start Date
October 2014
Completion Date
April 2017
Sponsors
Assiut University
Source
Assiut University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page