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Trial Title:
A Randomised Study of Consolidation CTRT Versus Observation After First Line Chemotherapy in Advanced Gallbladder Cancer
NCT ID:
NCT05493956
Condition:
Gallbladder Cancer Unresectable
Conditions: Official terms:
Gallbladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Consolidation chemoradiation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
chemoradiation
Description:
Radiation dose of 54 Gy will be given alongwith concurrent capecitabine
Arm group label:
Consolidation chemoradiation
Arm group label:
Observation
Other name:
Observation
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).
Detailed description:
Treatment:
Chemotherapy followed by Chemo-radiotherapy:
Patients in experimental arm will be administered 6 cycles of gemcitabine 1000 mg/m2 d
1+8 and cisplatin 25mg/m2 d 1+8 repeated 3 weekly followed by abdominal radiotherapy
using a standardized 3 dimensional conformal radiotherapy (3DCRT) technique on a linear
accelerator operating at beam energy of >= 6MV.The total target dose of RT will be 45Gy
in 25 fractions of 1.8 Gy to GBC and lymphatics (GBC, liver infiltration, periportal
coeliac, superior mesenteric and paraortic lymphnodes till L2) followed by a boost of 9
Gy to the GBC. GBC mass alongwith liver infiltration would be GTV, and a 5mm margin
around it would be GB_CTV. Nodal CTV would be delineated after combining PV, CA, SMA and
aortic nodes. A Boolean of GB_CTV and Nodal CTV would be Final CTV. PTV margin would be 1
cm around Final CTV. DVH constraints would be : mean liver dose<30 Gy (liver would be
delineated after subtracting GB_CTV), mean kidney dose <18 Gy (combining both kidneys).
Other OAR to be delineated: stomach, bowel and their doses to be noted. Concurrent
capecitabine to be given @1250 mg/m2 (Monday to Friday). Weekly clinical ,haemogram, LFT
assessments will be done during the treatment.
Toxicities documented during adjuvant therapy will be recorded using the CTCAE version
3.0 (NCI 2006 scale). Toxicities arising more than 90 days since the completion of
radiation therapy and attributed to radiation will be assessed according to CTCAE
criteria and counted as late radiation toxicities.
Observation : enrolled patients will be administered 6 cycles of gemcitabine 1000 mg/m2 d
1+8 and cisplatin 25mg/m2 d 1+8 repeated 3 weekly for 6 cycles and then kept on
observation.
QOL forms would be taken at baseline (before randomization, 2nd week RT and one week
after completion of RT.)
Follow-up:
Interim analysis will be done at 50% recruitment or at 1.5 years of study whichever is
earlier. After completion of treatment patients will be followed up and assessed
clinically every month till disease progression. A CECT abdomen at 2 months would be done
to assess response to treatment. Patients who develop symptoms of disease progression
would be advised CECT scan to confirm disease progression before administering
second-line chemotherapy (CAPIRI). Quality of Life assessment: This will be done using
FACT hepatic scale at the time of randomization, second week of radiotherapy and one
month after completion of radiotherapy.
In the control arm it will be assessed at the time of randomization, and at one month and
3 months of follow-up. Sample size estimation Assuming 2 year survival probability of the
patients were 0.25 and 0.08 in the treatment (group1) and control (group2), at minimum
two sided 95% confidence interval and 80% power of the study, overall sample size came
out to be 132 subjects (66 in the group1 and 66 in the group2) using a two-sided log rank
test. The proportion dropping out in each of the treatment and control group was 0.10
(ie10%). The proportion of switching from the treatment to control or control to
treatment is assumed to be Nil.
Therefore in this study 70-70 patients will be included in the treatment and control
groups (total 140).
Sample size was estimated using power analysis and sample size version-8 (PASS-2008).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Multiple liver Metastasis as evident on CT scan abdomen .
- Presence of ascites
- Presence of jaundice (obstructive jaundice)
- Poor performance status (KPS<70)
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Address:
City:
Lucknow
Zip:
226014
Country:
India
Status:
Recruiting
Contact:
Last name:
Sushma Agrawal, MD
Investigator:
Last name:
Rahul Rahul
Email:
Sub-Investigator
Investigator:
Last name:
Ashish Singh
Email:
Sub-Investigator
Investigator:
Last name:
Prabhakar Mishra
Email:
Sub-Investigator
Investigator:
Last name:
Rajan Saxena
Email:
Sub-Investigator
Start date:
April 1, 2019
Completion date:
February 2023
Lead sponsor:
Agency:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
American Society of Clinical Oncology
Agency class:
Other
Source:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05493956