NCT02981641

Brief Summary

The purpose of this study is to find the better radiation therapy between intraoperative radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

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

December 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 5, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 30, 2016

Last Update Submit

November 30, 2016

Conditions

Pancreatic Cancer Stage IV

Keywords

Pancreatic cancerIntraoperative radiotherapy (IORT)Concurrent Chemoradiotherapy (CCRT)

Outcome Measures

Primary Outcomes (1)

  • Overal survival

    OS

    3 years

Secondary Outcomes (3)

  • Disease-specific survival

    3 years

  • Progression-free survival

    3 years

  • Local control rate

    3 years

Study Arms (2)

Intraoperative radiotherapy (IORT) Group

EXPERIMENTAL

Radiotherapy (Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1) + Sequential chemotherapy

Radiation: Intraoperative radiotherapy (IORT)Drug: Sequential chemotherapy

Concurrent Chemoradiotherapy (CCRT) Group

EXPERIMENTAL

Three dimensional conformal radiation therapy (3D-CRT) (Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30) + Concurrent chemotherapy (Gemcitabine(GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d) + Sequential chemotherapy

Drug: Sequential chemotherapyRadiation: Three dimensional conformal radiation therapy (3D-CRT)Drug: Concurrent chemotherapy

Interventions

Intraoperative radiotherapy (IORT)RADIATION

Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1

Also known as: IORT
Intraoperative radiotherapy (IORT) Group
Sequential chemotherapyDRUG

Sequential chemotherapy

Also known as: SC
Concurrent Chemoradiotherapy (CCRT) GroupIntraoperative radiotherapy (IORT) Group
Three dimensional conformal radiation therapy (3D-CRT)RADIATION

Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30

Also known as: 3D-CRT
Concurrent Chemoradiotherapy (CCRT) Group
Concurrent chemotherapyDRUG

Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d

Also known as: CC
Concurrent Chemoradiotherapy (CCRT) Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed as locally advanced pancreatic cancer.
  • Cannot be treated by surgical resection.

You may not qualify if:

  • Treated by chemotherapy or radiotherapy before.
  • With distant organ metastasis.
  • Cannot tolerate surgery (Intraoperative radiotherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CancerIHCAMS

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Chengfeng Wang, B.A.

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianwei Zhang, Ph.D.

CONTACT

+8613581841816panchutong@163.com

Shuisheng Zhang, M.D.

CONTACT

+8618001302322thelifeofwater@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Abdominal Surgical Oncolgoy

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 5, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

December 5, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)