NCT02798510

Brief Summary

The present study is designed to determine whether adjuvant concurrent chemoradiotherapy improves overall survivals.

Trial Health

55
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Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

June 9, 2016

Last Update Submit

June 21, 2016

Conditions

Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct

Keywords

Gallbladder CarcinomaExtrahepatic CholangiocarcinomaChemoradiotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    24 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Patients in arm 1 will receive adjuvant chemotherapy followed by concurrent chemoradiotherapy. Patients will receive four cycles of gemcitabine (1,000mg/m2 intravenously on days 1 and 8) and capecitabine (1,500mg/m2 per day on days 1 to 14) every 21 days followed by concurrent capecitabine (1,330mg/m2 per day) and radiotherapy (50.4Gy/28fx to regional lymphatics with or without tumor bed)

Radiation: Concurrent ChemoradiotherapyDrug: capecitabineDrug: gemcitabine

Arm 2

ACTIVE COMPARATOR

Patients in arm 2 will receive six cycles chemotherapy of gemcitabine (1,000mg/m2 intravenously on days 1 and 8) and capecitabine (1,500mg/m2 per day on days 1 to 14) every 21 days

Drug: capecitabineDrug: gemcitabine

Interventions

Concurrent ChemoradiotherapyRADIATION
Arm 1
capecitabineDRUG
Arm 1Arm 2
gemcitabineDRUG
Arm 1Arm 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with pathologic diagnosis of gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) after radical resection.
  • The patients with pathologic stage T2-4 or N1 in R0 resection or positive resection margins (R1).
  • Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 6 months.
  • Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:
  • Blood: Absolute neutrophil count \> 1.5 × 109 / L, Platelet count \> 100 × 109 / L, Hb \> 8.0g/dl.
  • Liver function: serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 2.5 times the upper limit of normal.
  • Renal function: creatinine less than 1.5 times the upper limit of normal.
  • Patients who can understand the circumstances of this study and signed informed consent.

You may not qualify if:

  • Pregnancy, breast-feeding patients；
  • Patients received prior anticancer therapy for the current malignancy or upper abdominal radiotherapy or chemotherapy at any time.
  • Patients with malignant ascites.
  • Patients with purulent and chronic infected wounds which delayed healing.
  • Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
  • Patients has a history of mental illness and difficult to control;
  • Patients who was considered inappropriate to participate in the trials by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan university cancer hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Luvira V, Satitkarnmanee E, Pugkhem A, Kietpeerakool C, Lumbiganon P, Pattanittum P. Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD012814. doi: 10.1002/14651858.CD012814.pub2.

    PMID: 34515993DERIVED

MeSH Terms

Conditions

Gallbladder NeoplasmsCholangiocarcinoma

Interventions

ChemoradiotherapyCapecitabineGemcitabine

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapyDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • zhigang ren, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zhigang ren, MD

CONTACT

64175590zhigang-ren@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 14, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

CN(1)