A Phase II Study of Locally Advanced Pancreatic Cancer

NCT01867892 | Unknown Phase 2 DMC

• 1 other identifier: T2212
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary end point is to evaluate the 9-month progression free survival rate and safety profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer. The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.

Conditions

Pancreatic Cancer

Keywords

Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• the response rate, disease control rate, overall survival, and patients' quality of life.

  This is a randomized phase II trial of ICT followed by CCRT with radiotherapy in LAPC. The efficacy will be primarily measured by progression free survival (PFS) as defined in Section 8.5.Other measurements include the response rate, disease control rate, overall survival, and patients' quality of life as described in Section 8.We anticipate that the attrition rate is about 10%, hence, roughly 86 patients will be recruited , we anticipate that the recruitment will be completed in 4.5 years.

  4.5 years

Study Arms (2)

ICT of oxaliplatin,irinotecan,5-FU and leucovorinon and CCRT

EXPERIMENTAL

Arm1:oxaliplatin,irinotecan,5-FU and leucovorinon D1,15 every 28days for 3 cycles,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly

Drug: ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT

ICT of gemcitabine,oxaliplatin,5-FU,leucovorin and CCRT

ACTIVE COMPARATOR

Arm 2:gemcitabine,oxaliplatin,5-FU,leucovorin on D1,15 every 28 days for 3 cycles,Evaluation of Tumor Response,CR/PR/SD or localized disease RT 5,040cGy in 28 fractions/ 5.5 wks Arm 2: Gem 400mg/m2 iv 40min weekly

Drug: ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT

Interventions

ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT DRUG

oxapliplatin ,irinotecan ,5FU +leucovorin ,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly

Also known as: ICT of oxapliplatin,irinotecan,leucovorin,and fluorouracil and CCRT

ICT of oxaliplatin,irinotecan,5-FU and leucovorinon and CCRT

ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT DRUG

Gem ,Oxa ,5FU +LV ,RT 5,040cGy in 28 fractions/5.5 wks and Gem 400mg/m2 iv 40min weekly

Also known as: ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil +CCRT

ICT of gemcitabine,oxaliplatin,5-FU,leucovorin and CCRT

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
• Patients must have locally advanced pancreatic cancer (LAPC).
• Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
• Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
• extension to the celiac axis or superior mesenteric artery,
• occlusion of the superior mesenteric-portal venous confluence
• aortic, inferior vena cava (IVC) invasion or encasement
• invasion of SMV below transverse mesocolon or unresectable after surgical exploration.
• Those who had superior mesenteric vein impingement, superior mesenteric artery abutment were defined as borderline resectable.
• Those who had superior mesenteric vein occlusion, superior mesenteric artery encasement were defined as unresectable.
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
• Age \>20 years and ≦70 years.
• ECOG performance score of 0 or 1; see Appendix A.
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count \>1,500/mL

You may not qualify if:

• Patients with distant metastases are not eligible.
• Patients with endocrine or acinar pancreatic carcinoma.
• Patients may be receiving any steroid, immunologic or other investigational agents within 4 weeks prior to enrollment.
• Patients who have had prior chemotherapy or radiotherapy are not eligible.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
• Patients who have above grade II peripheral neuropathy.
• Patients who had non-curable second primary malignancy within five years, except for non-melanoma skin cancer.
• 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.
• Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
• Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study because of increased risk of lethal infections and possible pharmacokinetic interactions with study agent administered during the study.
• Those who have chronic diarrhea.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

Related Publications (1)

• Su YY, Chiu YF, Li CP, Yang SH, Lin J, Lin SJ, Chang PY, Chiang NJ, Shan YS, Ch'ang HJ, Chen LT. A phase II randomised trial of induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer: the Taiwan Cooperative Oncology Group T2212 study. Br J Cancer. 2022 Apr;126(7):1018-1026. doi: 10.1038/s41416-021-01649-7. Epub 2021 Dec 17.

  PMID: 34921230 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Irinotecan; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yen-Shen Shen, M.D.

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

• Chih-Hung Hsu, Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Ruey-Kuen Hsieh, M.D.

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Jen-Shi Chen, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: June 4, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: June 4, 2013

Record last verified: 2013-05