NCT05493956

Brief Summary

This will be a phase III randomized trial of advanced gall bladder cancers. 140 patients will be randomized. Randomisation will be on a 1:1 ratio between the experimental arm and the control arm. Observation Arm : 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by observation Chemotherapy followed by Chemo-radiotherapy Arm (CTRT): 6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by Concurrent Chemo-radiation with capecitabine (experimental arm).

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 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

April 1, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 9, 2022

Status Verified

August 1, 2022

Enrollment Period

3.7 years

First QC Date

August 3, 2022

Last Update Submit

September 7, 2022

Conditions

Gallbladder Cancer Unresectable

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Time from diagnosis to death

    one year

Secondary Outcomes (3)

  • Progression free survival

    one year

  • Toxicity due to consolidation chemoradiation

    24 weeks

  • Hepatobiliary symptom index

    24 weeks

Study Arms (2)

Consolidation chemoradiation

EXPERIMENTAL

6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by Concurrent Chemo-radiation with capecitabine

Radiation: chemoradiation

Observation

ACTIVE COMPARATOR

6 cycles of Chemotherapy with Gemcitabine and Cisplatin will be followed by observation

Radiation: chemoradiation

Interventions

chemoradiationRADIATION

Radiation dose of 54 Gy will be given alongwith concurrent capecitabine

Also known as: Observation
Consolidation chemoradiationObservation

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rt hepatic artery involvement
  • Rt Branch of portal vein and main PV involvement
  • CBD/CHD/primary biliary confluence involvement
  • Duodenum, pancreas, colon involvement
  • omental metastases, liver involvement limited to segment 4,5
  • Nodes in the hepato-duodenal, peripancreatic, common hepatic artery region, Para or preaortic region
  • Good performance status
  • BMI \>15
  • Have normal organ and marrow function

You may not qualify if:

  • Multiple liver Metastasis as evident on CT scan abdomen .
  • Presence of ascites
  • Presence of jaundice (obstructive jaundice)
  • Poor performance status (KPS\<70)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

MeSH Terms

Interventions

ChemoradiotherapyObservation

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapyMethodsInvestigative Techniques

Study Officials

  • Sushma Agrawal, MD

    SGPGIMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sushma Agrawal, MD

CONTACT

91522249sushmaagrawal@yahoo.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Consolidation chemoradiation
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 9, 2022

Study Start

April 1, 2019

Primary Completion

December 1, 2022

Study Completion

February 1, 2023

Last Updated

September 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)