NCT01458717

Brief Summary

Previous reports suggest benefit of neoadjuvant chemoradiation treatment for borderline resectable pancreas cancer. This study is a multicenter prospective randomized phase II/III study of neoadjuvant chemoradiation with gemcitabine in patients with borderline resectable pancreas cancer. The study is designed in 2 arms, one with upfront surgery and the other with neoadjuvant chemoradiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_2 pancreatic-cancer

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

6.2 years

First QC Date

October 19, 2011

Last Update Submit

April 30, 2018

Conditions

Pancreatic Cancer

Keywords

pancreascancerborderline resectablelocally advancedresectabilitychemotherapyradiationchemoradiationneoadjuvantsurvivalprognosisrecurrenceresponse rate

Outcome Measures

Primary Outcomes (1)

  • 2-year survival rate

    2-year actual survival outcome

    2-year actual survival outcome

Secondary Outcomes (7)

  • Median survival

    after at least of 2-years follow up of all participants

  • 1-year survival rate

    after at least of 1-year follow up of all participants

  • R0 resection rate

    within 3 weeks after operation

  • curative resection rate

    within 3 weeks after operation

  • local recurrence

    within at least 2-years follow up

  • +2 more secondary outcomes

Study Arms (2)

Neoadjuvant

EXPERIMENTAL

Neoadjuvant - operation - maintenance chemotherapy

Drug: Neoadjuvant chemoradiation

Upfront surgery

ACTIVE COMPARATOR

Operation - adjuvant chemoradiation - maintenance chemotherapy

Procedure: Upfront surgery

Interventions

Neoadjuvant chemoradiationDRUG

* Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * 4 weeks rest, re-evaluation for resectability * operation * start maintenance chemotherapy within 4\~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle

Neoadjuvant
Upfront surgeryPROCEDURE

* Operation at time of diagnosis * Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡ * start maintenance chemotherapy within 4\~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle

Upfront surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years old or \<75 years old
  • ECOG 0-2
  • biopsy proven adenocarcinoma of the pancreas
  • no history of previous chemotherapy
  • borderline resectable pancreas cancer
  • no distant metastasis
  • WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
  • Bilirubin less than 2.5 mg/dL AST less than 5 times upper limit of normal
  • Creatinine no greater than 1.5 times upper limit of normal
  • informed consent

You may not qualify if:

  • history of previous chemotherapy
  • history of radiation at \>25% area of bone marrow
  • stage unspecified, with distant metastasis, recurrent pancreas cancer
  • history of malignant neoplasm (except stage 0 cancer, skin in situ cancer except malignant melanoma). Patients who are NED after 5 years after treatment of malignant neoplasm can be candidate of this study
  • pregnant, breast-feeding patient
  • uncontrolled or active infection
  • uncontrolled cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Center for Liver Cancer, National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasmsRecurrence

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Jin-Young Jang, M.D., Ph.D.

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

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
Associate professor

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 25, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

KR(5)