NCT02754180

Brief Summary

Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

April 20, 2016

Last Update Submit

April 27, 2016

Conditions

Pancreatic Neoplasms

Keywords

adjuvantpancreatic cancerR1 resectionpositive lymph nodes

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    From date of randomization until the date of first documented disease recurrence or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (2)

  • overall survival

    From date of randomization until the date of death from any cause, assessed up to 36 months

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    from randomization to 1 month after end of treatment

Study Arms (2)

chemotherapy

ACTIVE COMPARATOR

gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles.

Drug: Gemcitabine

chemotherapy with chemoradiation

EXPERIMENTAL

gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.

Drug: GemcitabineRadiation: TS-1 with radiation

Interventions

GemcitabineDRUG

gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles

Also known as: chemotherapy
chemotherapychemotherapy with chemoradiation
TS-1 with radiationRADIATION

gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.

chemotherapy with chemoradiation

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
  • Subject should start treatment no later than 10 weeks postsurgery.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Acceptable hematology parameters:
  • Absolute neutrophil count ≥1500 cell/mm3
  • Platelet count ≥100,000/mm3
  • Hemoglobin (Hgb) ≥8.0 g/dL
  • Acceptable blood chemistry levels:
  • Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
  • Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
  • Serum creatinine within upper limits of normal.
  • Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
  • No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
  • Signed informed consent.

You may not qualify if:

  • R2 resection or presence of metastatic disease.
  • Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
  • Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
  • Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the 6 months of study registration
  • Uncontrolled hypertension, diabetes or arrhythmia.
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
  • Not able to take medicine orally.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Medical Oncology, Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineDrug Therapytitanium silicideRadiation

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTherapeuticsPhysical Phenomena

Central Study Contacts

Bai Chunmei, MD

CONTACT

861069158773baichunmei1964@163.com

Cheng Yuejuan, MD

CONTACT

861069158773cnchengyuejuan@yahoo.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
MD

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 28, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2021

Last Updated

April 28, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)