FOLFIRINOX + RT for Pancreatic Cancer

NCT01591733 | Unknown Phase 2 Results DMC

• 1 other identifier: 11-328
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Borderline resectable

Outcome Measures

Primary Outcomes (1)

• Rate of R0 Resection

  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.

  Post-surgery (about 4 months post baseline)

Secondary Outcomes (10)

• Median Progression-Free Survival

  From the start of treatment until death or disease progression, median duration of follow-up of 14.7 months

• Median Overall Survival

  From the start of treatment until the time of death, median duration of follow-up of 37.7 months

• Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation

  From the start of treatment until the end of chemoradiation, about 4 months

• The Proportion of Participants With Surgery Related Adverse Events

  At the time of surgery, 30 days post-surgery

• 30 Day Post-operative Mortality Rate

  30 days post surgery (about 6 months from baseline)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy.

Drug: FOLFIRINOX; Drug: Capecitabine; Radiation: Short Course Radiation; Procedure: Surgery

Interventions

FOLFIRINOX DRUG

Up to Eight-14 day cycles

Also known as: 5-FU, Oxaliplatin, Irinotecan

Treatment Arm

Capecitabine DRUG

Orally, for 10 days

Treatment Arm

Short Course Radiation RADIATION

Five or ten days

Treatment Arm

Surgery PROCEDURE

1-4 weeks after completion of capecitabine therapy

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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, Fernandez-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.

  PMID: 29800971 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox; Fluorouracil; Oxaliplatin; Irinotecan; Capecitabine; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Theodore Hong
• Organization: Massachusetts General Hospital

TSHONG1@mgh.harvard.edu

617-726-6050

Study Officials

• Theodore S Hong, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: May 4, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: January 1, 2022
• Last Updated: May 28, 2021
• Results First Posted: April 30, 2018

Record last verified: 2021-05

Locations

US (1)