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FOLFIRINOX + RT for Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01591733
First received: April 20, 2012
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a therapy to learn whether the therapy works in treating a specific cancer. "Investigational" means that the therapy is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if therapy is effective for treating different types of cancer. Proton beam radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery system.

Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as it delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy, which tends to include more normal tissue along with tumor target tissue.

Researchers in the laboratory have discovered that there are pathways inside the cells that can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and capecitabine are targeted towards blocking the pathways that allow cancer cells to divide, and may result in the tumor shrinking in size.

In this research study, the investigators are looking to determine if proton beam radiation in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of your cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: FOLFIRINOX
Drug: Capecitabine
Radiation: Short Course Radiation
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy for Borderline-Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Rate of Resection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas


Secondary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the progression-free survival of patients who receive preoperative FOLFIRINOX and preoperative short-course radiation therapy

  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine overall survival in patients treated with preoperative FOLFIRINOX and short course radiation therapy

  • Toxicity rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine the frequency and severity of toxicities of FOLFIRINOX+short course radiation therapy in patients with pancreatic cancer

  • Surgical Morbidity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the surgical morbidity in patients undergoing pancreaticoduodenectomy or distal pancreatectomy who received preoperative FOLFIRINOX and preoperative short course radiation therapy

  • 30 Day Post-operative Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine 30 day post-operative mortality after pancreaticoduodenectomy or distal pancreatectomy in patients who receive preoperative FOLFIRINOX and short course radiation therapy

  • Rate of Pathologic Downstaging [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the rate of pathologic down-staging of FOLFIRINOX+short course radiation therapy for patients with pancreatic cancer

  • Local Control Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine local control rates with FOLFIRINOX+preoperative short course radiation therapy

  • Correlation of Mutational Analysis Biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment


Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.
Drug: FOLFIRINOX
Four-14 day cycles
Other Names:
  • 5-FU
  • Oxaliplatin
  • Irinotecan
Drug: Capecitabine
Orally, for 10 days
Radiation: Short Course Radiation
Five or ten days
Procedure: Surgery
1-4 weeks after completion of capecitabine therapy

Detailed Description:

The treatment plan will begin with four cycles (8 weeks) of FOLFIRINOX. Each cycle is 14 days long. You will receive FOLFIRINOX therapy on days 1, 2 and 3 of each of the four cycles. The FOLFIRINOX treatment is broken up into three different drugs. 5-FU will be administered over two hours on day one of each cycle, and then continuously with a pump for days 2 and 3. Oxaliplatin will be delivered by intravenous (infusion)over 120 minutes. Irinotecan will be given by IV for 90 minutes. All parts of this treatment will be received as an outpatient.

You will take tablets of capecitabine by mouth for a total of 10 days (Monday through Friday) during the two weeks after your FOLFIRINOX treatment.

You will be given a drug diary for capecitabine which contains instructions on how to take the drug.

Short course radiation: You will receive proton radiation treatment for five days (Monday through Friday) after your FOLFIRINOX treatment, during the time of your capecitabine treatment, or photon radiation for ten days (Monday through Friday for two weeks). You will also be assessed at least once during this treatment course for any side effects you may be experiencing.

You will receive study radiation treatment as an outpatient at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at the Massachusetts General Hospital Surgery is expected to occur approximately one to four weeks after completion of capecitabine therapy.

After your surgery, you will continue with four additional months of therapy with FOLFIRINOX if you are well enough to receive it. You will also have follow up visits after surgery every 3 months for as long as your tumor does not grow.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cytologic or histologic proof pancreatic ductal carcinoma
  • Borderline resectable
  • Body and tail lesions
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Evidence of metastatic disease
  • Pregnant or breastfeeding
  • Other serious uncontrolled medical conditions
  • Prior chemotherapy, targeted/biologic therapy or radiation for treatment of the pancreatic tumor
  • Prior systemic fluoropyrimidine therapy
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591733

Contacts
Contact: Theodore Hong, MD 6177241700 tshong1@partners.org
Contact: Tarin Grillo 617-724-3661 tgrillo@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Theodore Hong, MD    617-724-1700    tshong1@partners.org   
Principal Investigator: Theodore Hong, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Theodore S Hong, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Theodore Sunki Hong, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01591733     History of Changes
Other Study ID Numbers: 11-328
Study First Received: April 20, 2012
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Borderline resectable

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Capecitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014