Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035072
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Unresectable Pancreatic Cancer Nonmetastatic Pancreatic Cancer Locally Advanced Pancreatic Cancer Drug: Gemcitabine Drug: Oxaliplatin Radiation: Hypofractionated RT Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.
Study Start Date : November 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Hypofractionated RT + Gem + Oxali
Hypofractionated radiotherapy + Gemcitabine + Oxaliplatin
Drug: Gemcitabine
Gemcitabine 1000 mg/m2

Drug: Oxaliplatin
Oxaliplatin 100 mg/m2
Other Name: oxalipaltin

Radiation: Hypofractionated RT
Hypofractionated radiotherapy (35 Gy in 7 fractions)




Primary Outcome Measures :
  1. Toxicity [ Time Frame: 15 months after the start of recruitment ]

    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.


  2. Proportion of resectable patients [ Time Frame: 3 years after the start of recruitment ]
    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.


Secondary Outcome Measures :
  1. Objective tumor response [ Time Frame: 3 years after the start of recruitment. ]
    It is assessed using RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

  2. Objective tumor response rate (ORR) [ Time Frame: 3 years after the start of recruitment. ]
    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. Overall survival (OS) [ Time Frame: 3 years after the start of recruitment ]
    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).

  4. Progression free survival (PFS/local PFS) [ Time Frame: 3 years after the start of recruitment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer are candidates for the trial.
  2. Stage III disease (AJCC TNM 6th edition, 2002). Inoperable disease, by radiological and surgical evaluation;
  3. Age >18 years and ≤75 years.
  4. Life expectancy of greater than 12 weeks.
  5. ECOG performance status 0-2 (see Appendix A).
  6. Presence of at least of one measurable lesion in agreement to RECIST criteria
  7. Patients must have normal organ and marrow function as defined below:

    • Leukocytes >3,000/uL
    • Absolute neutrophil count >1,500/uL
    • Platelets >100,000/uL
    • Total bilirubin < 1.5 X ULN
    • AST (SGOT)/ALT (SGPT) <2.5 X ULN
    • Creatinine < 1.5 X ULN
  8. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients who have had any chemotherapy or radiotherapy prior to entering the study;
  2. Stage IV disease;
  3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  4. Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated >5 years before study entry.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and oxaliplatin or other agents used in the study.
  6. Active brain or leptomeningeal disease
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035072


Locations
Layout table for location information
Italy
Radiotherapy Unit, IRCCS IRST
Meldola, FC, Italy, 47014
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
Layout table for investigator information
Principal Investigator: Antonino Romeo, MD IRST IRCCS, Meldola

Layout table for additonal information
Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT02035072     History of Changes
Other Study ID Numbers: IRST157.01
2010-020379-22 ( EudraCT Number )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs