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Trial record 1 of 1 for:    NCT01591733
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FOLFIRINOX + RT for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01591733
Recruitment Status : Active, not recruiting
First Posted : May 4, 2012
Results First Posted : April 30, 2018
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Theodore Sunki Hong, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE April 20, 2012
First Posted Date  ICMJE May 4, 2012
Results First Submitted Date  ICMJE March 2, 2018
Results First Posted Date  ICMJE April 30, 2018
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
Rate of R0 Resection [ Time Frame: Post-surgery (about 4 months post baseline) ]
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. R0 resection means that following surgery, no cancer cells are seen microscopically at the resection margin.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Rate of Resection [ Time Frame: 2 years ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • Median Progression-Free Survival [ Time Frame: From the start of treatment until death or disease progression, median duration of follow-up of 14.7 months ]
    The median progression free survival as measured from the start of treatment until the time of disease progression or death, whichever occurs first. Disease status was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Disease progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
  • Median Overall Survival [ Time Frame: From the start of treatment until the time of death, median duration of follow-up of 37.7 months ]
    Median overall survival, as measured from the start of treatment until the time of death.
  • Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation [ Time Frame: From the start of treatment until the end of chemoradiation, about 4 months ]
    Frequency of grade 3 or greater adverse events deemed related to FOLFIRINOX+short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
  • The Proportion of Participants With Surgery Related Adverse Events [ Time Frame: At the time of surgery, 30 days post-surgery ]
    The number of participants with surgery related any grade adverse events following pancreaticoduodenectomy or distal pancreatectomy after receiving preoperative FOLFIRINOX and preoperative short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
  • 30 Day Post-operative Mortality Rate [ Time Frame: 30 days post surgery (about 6 months from baseline) ]
    The number of participants that died within 30 days after undergoing pancreaticoduodenectomy or distal pancreatectomy.
  • Rate of Pathologic Downstaging [ Time Frame: Baseline, Post surgery ]
    To determine the rate of pathologic down-staging among participants that underwent pancreaticoduodenectomy or distal pancreatectomy. The pathologic downstaging rate is the proportion of patients with the primary tumor and nodes downstaged based on final pathology of the surgical specimen.
  • Local Control Rates [ Time Frame: From the start of treatment until the end of treatment with FOLFIRINOX, or until disease progression (median duration of follow-up of approximately 14 months) ]
    The number of participants that achieved local control. Local control was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Local Failure is defined as progression of the primary tumor, or to the reappearance of tumor at the primary site.
  • Correlation of Mutational Analysis Biomarkers [ Time Frame: 2 years ]
    To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment
  • Quality of Life, Symptom Burden, and Mood [ Time Frame: 2 years ]
    Patient-reported outcomes: We will use descriptive statistics to describe Quality of Life (QOL) (EORTC QLQ-C30), symptom burden (ESAS-r) and mood (HADS) for the entire study cohort.
  • Utilization of Health Services (Emergency Room, Hospital and Intensive Care Unit) [ Time Frame: 2 years ]
    Summary of the number of hospitalizations, intensive care unit (ICU) stays, emergency department (ED) stays, and palliative care use for the study population.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Progression-Free Survival [ Time Frame: 2 years ]
    To determine the progression-free survival of patients who recieve preoperative FOLFIRINOX and preoperative short-course proton therapy
  • Overall Survival [ Time Frame: 2 years ]
    To determine overall survival in patients treated with preopertive FOLFIRINOX and proton beam radiation therapy
  • Toxicity rate [ Time Frame: 2 years ]
    To determine the frequency and severity of toxicities of FOLFIRINOX+proton beam radiation therapy in patients with pancreatic cancer
  • Surgical Morbidity [ Time Frame: 2 years ]
    To determine the surgical morbidity in patients undergoing pancreaticoduodenectomy or distal pancreatectomy who received preoperative FOLFIRINOX and preoperative proton therapy
  • 30 Day Post-operative Mortality [ Time Frame: 2 years ]
    To determine 30 day post-operative mortality after pancraeticoduodenectomy or distal pancreatectomy in patients who receive preoperative FOLFIRINOX and proton therapy
  • Rate of Pathologic Downstaging [ Time Frame: 2 years ]
    To dermine the rate of pathologic downstaging of FOLFIRINOX+short course proton therapy for patients with pancreatic cancer
  • Local Control Rates [ Time Frame: 2 years ]
    To determine local control rates with FOLFIRINOX+preoperative proton therapy
  • Correlation of Mutational Analysis Biomarkers [ Time Frame: 2 years ]
    To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FOLFIRINOX + RT for Pancreatic Cancer
Official Title  ICMJE Phase II Study of Preoperative FOLFIRINOX Followed by Accelerated Short Course Radiation Therapy for Borderline-Resectable Pancreatic Cancer
Brief Summary

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.

Detailed Description

For weeks 1-8, you will only be receiving FOLFIRINOX via IV infusion. 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.

If after 4 cycles of FOLFIRINOX therapy, your tumor has not spread, you will receive a further 4 cycles of FOLFIRINOX. If after 8 total cycles of FOLFIRINOX your cancer is clearly resectable, you will proceed to phase 2 of treatment with capecitabine and radiation therapy.

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 may receive additional chemotherapy at the discretion of your treating physician and be followed as per standard of care.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: FOLFIRINOX
    Up to Eight-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
Study Arms  ICMJE Experimental: Treatment Arm
All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.
Interventions:
  • Drug: FOLFIRINOX
  • Drug: Capecitabine
  • Radiation: Short Course Radiation
  • Procedure: Surgery
Publications * Murphy JE, Wo JY, Ryan DP, Jiang W, Yeap BY, Drapek LC, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Faris JE, Zhu AX, Goyal L, Lillemoe KD, DeLaney TF, Fernández-Del Castillo C, Ferrone CR, Hong TS. Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):963-969. doi: 10.1001/jamaoncol.2018.0329. Erratum in: JAMA Oncol. 2018 Oct 1;4(10):1439.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 28, 2018)
48
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2012)
50
Estimated Study Completion Date  ICMJE January 2022
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cytologic or histologic proof pancreatic ductal carcinoma
  • Borderline resectable
  • Life expectancy of at least 3 months
  • ECOG Performance Status ≤ 1
  • Adequate organ and bone marrow function
  • No treatment of other invasive cancers within the last 5 years with greater than 5% risk of recurrence at the time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowed
  • > 4 weeks since major surgery, excluding laparoscopy

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
  • Individuals on cimetidine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591733
Other Study ID Numbers  ICMJE 11-328
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theodore Sunki Hong, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Theodore S Hong, M.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP