Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer

NCT02635971 | Unknown Phase 2 DMC

• 1 other identifier: TAI-2015
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).

Conditions

Carcinoma, Pancreatic

Keywords

transcatheter arterial infusion; randomized controlled trial; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of randomization until the date of death, assessed up to 100 months.

Secondary Outcomes (1)

• Progression free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Study Arms (2)

TAI chemotherapy

EXPERIMENTAL

Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.

Procedure: Transcatheter arterial infusion; Drug: Gemcitabine; Drug: Oxaliplatin

Chemotherapy

ACTIVE COMPARATOR

Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment.

Procedure: Intravenous chemotherapy; Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

Transcatheter arterial infusion PROCEDURE

TAI chemotherapy

Intravenous chemotherapy PROCEDURE

Chemotherapy

Gemcitabine DRUG

Chemotherapy; TAI chemotherapy

Oxaliplatin DRUG

Chemotherapy; TAI chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
• Measurable disease by RECIST criteria must be present.
• Karnofsky Performance Status ≥ 70
• Patients with adequate organ functions reflected by the laboratory criteria below:
• Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine \< 2.0 mg/dL Bilirubin \< 1.5 mg/dL SGPT \< 2.5 x normal Alk Phos \< 2.5 x normal
• Prior local therapy, e.g., radiation, is allowed provided that at least 4 weeks washout time is given.
• Patients with jaundice must have a biliary drainage decompression operation before recruitment.
• Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Subject with metastatic disease.
• Prior treatment with systemic chemotherapy.
• Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
• Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
• Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
• Concurrent infection requiring intravenous antibiotics.
• Skin injury or infection of groin area, or other situation that not appropriate for femoral artery puncture.
• Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
• Known central nervous system involvement and leptomeningeal disease
• Subject with previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
• Pregnant or lactating women.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Huang C, Cheng CS, Shen Y, Chen H, Lin J, Hua Y, Feng L, Wu C, Wang P, Chen Z, Meng Z. Digital subtraction angiography-guided pancreatic arterial infusion of GEMOX chemotherapy in advanced pancreatic adenocarcinoma: a phase II, open-label, randomized controlled trial comparing with intravenous chemotherapy. BMC Cancer. 2024 Aug 2;24(1):941. doi: 10.1186/s12885-024-12695-8.

  PMID: 39095759 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Zhiqiang Meng, MD, Ph D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yehua Shen, MD, Ph D

CONTACT

86-21-64175590; yehuash25@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Ph D

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 21, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

CN (1)