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2010-11
2016-12
2016-12
40
NCT02035072
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
INTERVENTIONAL
Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.
Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer. Protocol code: IRST157.01 Phase: II Study Design: monocentric, prospective, open-label not randomized trial. Description of Study Treatment: radio-chemotherapy schedule * GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every 2 weeks for 4 cycles. * Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy cycle. * Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy. Objectives: Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary objective = the control of IM (internal margin) intra-fraction. Step B: primary objective = to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of combinated treatment;overall survival (OS); local progression free survival (LPFS) and progression free survival (PFS). Statistical Considerations: Step A: Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients, the treatment can be considered safe with a probability > 90%. If 1 toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more patients needs to be recruited. If no further toxicity involving the radiotherapy treatment discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%. If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed, the study will be stopped because not safe and another kind of radiotherapy schedule must be designed. Step B: If the radiotherapy treatment will be considered no toxic, the study will continue in Step B : the goal of this phase II study is to increase the proportion of resectable patients of at least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years, and a further one-year period of follow-up is requested. If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-01-10 | N/A | 2017-07-19 |
2014-01-10 | N/A | 2017-07-21 |
2014-01-14 | N/A | 2017-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Hypofractionated RT + Gem + Oxali Hypofractionated radiotherapy + Gemcitabine + Oxaliplatin | DRUG: Gemcitabine
DRUG: Oxaliplatin
RADIATION: Hypofractionated RT
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Toxicity | If no toxicity in 11 patients, the treatment can be considered safe with a probability > 90%. If 1 toxicity will be observed, 7 more patients needs to be recruited. If no further toxicity occurs, the treatment could be considered safe with a probability ≥ 90%. If 2 or more toxicity in 11 patients or 2 or more in18 patients will be observed, the study will be stopped because not safe. | 15 months after the start of recruitment |
| Proportion of resectable patients | If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active. | 3 years after the start of recruitment |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective tumor response | It is assessed using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. | 3 years after the start of recruitment. |
| Objective tumor response rate (ORR) | It is defined as the proportion of the intention-to-treat (ITT) population showing a complete or partial response, if confirmed ≥ 4 weeks later. | 3 years after the start of recruitment. |
| Overall survival (OS) | It is counted from the date of registration to the date of death due to any cause or last date the patient was known to be alive (censored observation). | 3 years after the start of recruitment |
| Progression free survival (PFS/local PFS) | It is counted from the date of registration to the date of the first observation of documentation of objective disease progression/local disease progression or death due to any cause, whichever occurs first. | 3 years after the start of recruitment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
