Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas

NCT ID: NCT02311439

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-04-30

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.

Conditions

Cancer of Pancreas

Keywords

Locally advanced pancreatic cancer; Chemotherapy; Radiotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRINOX + CRT

FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation radiotherapy concurrent with capecitabine 625mg/m2 BID in non-progressed cases, in treating patients with locally advanced cancer pancreas.

Group Type: EXPERIMENTAL

FOLFIRINOX + CRT

Intervention Type: DRUG

Induction 4 times chemotherapy, FOLFIRINOX regimen, consisted of Oxaliplatin at a dose of 85 mg/m2 D1, 2-hour I.V + Irinotecan 180 mg/m2 D1 90-minute I.V. + Leucovorin 200 mg/m2 2- hour I.V, D1,2 + (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, will be followed by consolidation concurrent radiotherapy with capecitabine 625 mg/m2 BID.

Radiotherapy :

A fractionated dose of 50.4Gy /28 fractions/15 MeV photon energy generated by Dual-energetic Linear Accelerator.

Interventions

FOLFIRINOX + CRT

Induction 4 times chemotherapy, FOLFIRINOX regimen, consisted of Oxaliplatin at a dose of 85 mg/m2 D1, 2-hour I.V + Irinotecan 180 mg/m2 D1 90-minute I.V. + Leucovorin 200 mg/m2 2- hour I.V, D1,2 + (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, will be followed by consolidation concurrent radiotherapy with capecitabine 625 mg/m2 BID.

Radiotherapy :

A fractionated dose of 50.4Gy /28 fractions/15 MeV photon energy generated by Dual-energetic Linear Accelerator.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Allam Abdelhamed Mohamed

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University Hospitals

Asyut, Asyut Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Mohamed, MSc

Role: CONTACT

Phone: 00201221657931

Email: a_allamnafady@yahoo.co.uk

Facility Contacts

Samir Eid, Professor

Role: primary

Other Identifiers

LAP001

Identifier Type: -

Identifier Source: org_study_id