Gall Bladder CancersPhase 2/3POLCAGBNCT02867865
Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers
A Phase 2/3 study testing Gemcitabine, Cisplatin and Chemoradiation in people with Gall Bladder Cancers, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Gall Bladder Cancers
- What is being tested?
- Gemcitabine, Cisplatin and Chemoradiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIndia
- Study dates
- 6 Sep 2016to 10 Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced T3 or T4 tumors with one or more of the following:
- -> 2 cm but < 5 cm liver invasion
- Radiological involvement of antropyloric region of stomach, duodenum, hepatic flexure of colon or small intestine, but without infiltration of the mucosa on endoscopy.
- Type I/II invasion -Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct) causing obstructive jaundice
- Radiological suspicion of lymph node involvement N1 {stations 8, 12, 13) Hepatic artery (Station 8), hepatoduodenal ligament (Station 12), retropancreatic/retroduodenal (Station 13) i.e. size>1cm in short axis, round in shape, and heterogenous enhancement on PET scan.
- Vascular involvement : impingement/ involvement (<180 degree angle) of one or more of the following blood vessels common hepatic artery/ right hepatic artery/main portal vein/right portal vein (stage III disease)
Show all 10Show fewer
- Patient who have undergone prior cholecystectomy having residual disease with at least one of the above features.
- Biopsy/ cytology proven adenocarcinoma
- More than 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Normal hematological and renal and hepatic functions (serum bilirubin < 3mg/dl)
Who cannot join
- Resectable disease
- Evidence of distant metastasis (Liver, Lung, peritoneum, port site etc)
- Involving major part of the liver precluding restriction of full RT doses
- Received any prior radiation or chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is not common western world and thus there is lack of evidence regarding the impact of neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo R0 resection in few published studies. Also if the patients develop distant metastasis during this neoadjuvant therapy they can be spared of unnecessary surgery.
In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35 and 20 months for the patients undergoing R0 resection.
In this study the investigators intend to compare the effects of using neoadjuvant chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall bladder cancers in terms of down staging and overall survival.
Read the detailed description
Introduction:
Adenocarcinoma of the gallbladder (GBCA) is the most common malignancy of the biliary tract and its incidence is alarmingly high in the Indian subcontinent. Complete surgical excision is the standard of care for both gallbladder and pancreatic cancers. Unfortunately, majority of these cancers are diagnosed at an advanced, inoperable stage and only 10-30% of the patient present with resectable disease.
Gall bladder cancers which are T3/T4 with liver infiltration, with or without visceral/vascular infiltration or having large local lymph node metastases; in the absence of distant metastases are generally considered as locally advanced. There prognosis in terms of resectability and survival remains dismal in most of the reports.
Even with aggressive surgery like extrahepatic bile duct resection or pancreaticoduodenectomy the 5 year survival rate for stage III disease ranges 30% to 42% in best of the reports. But these results are often not reproducible.
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. In a randomized trial combination chemotherapy of Gemcitabine and cisplatin was superior to Gemcitabine chemotherapy alone and local tumor response in terms of partial downsizing or stable disease was achieved in 81% of cases. With Gemcitabine and Cisplatin based Neoadjuvant chemotherapy (NACT) some locally advanced GB cancers do get downstaged to undergo resection. Recent publication from Tata Memorial Centre, where NACT alone was given which resulted in surgical resection rate of 43% median OAS and PFS being 13 months and 8 months.
Study methodology:
All patients with diagnosis of non metastatic locally advanced Gall bladder cancers who fulfill the study eligibility criteria will be evaluated for study participation and will undergo Positron emission tomography and contrast enhanced computerized tomography (PETCECT) scan and staging laparoscopy to rule out metastatic disease. Patients will undergo upfront randomization into one of the study arms.
A proportion of patients are expected to have jaundice or cholangitis at presentation. At study inclusion there should be no clinical evidence of active cholangitis or unresolved biliary obstruction. Liver Function Tests, Renal Function Tests and CA 19-9 within 4 weeks of treatment initiation.
Systemic Chemotherapy arm (Standard Arm or Arm A)
Those randomized to NACT will proceed to receive systemic gemcitabine 1000 mg/m2delivered day 1 and 8 every 3 weeks and cisplatin 25 mg/m2 for and 4 cycles (week 1- week 11).
Chemoradiation arm (Study Arm or Arm B)
The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2). Radiotherapy will be for 5 weeks which will be followed by 2 cycles of chemotherapy (week 7 to week 11)
These radiotherapy (RT) doses have found to be safe in the investigators pilot study.
During week 12-13 patients will undergo repeat PETCECT scan. If the scan shows partial or good response then patients will be evaluated for surgery. Surgery if possible will be done between weeks 13-15. In case of inoperable disease patients will receive further chemotherapy. With locally progressive/systemic disease on chemotherapy patients may be considered for second line palliative chemotherapy or best supportive care. The use of radical dose chemoradiation is not allowed on disease progression in the systemic chemotherapy arm. However palliative radiation may be used.
Surgery
Surgical procedure will be en-bloc resection including cholecystectomy with a liver wedge excision and periportal lymph node clearance. Nodal clearance from station number 8, 12, 13 with sampling of inter aortocaval node will be done. Extrahepatic biliary excision or additional organ excision will be done as per the discretion of operating surgeon.
Post Surgery all patients will receive additional adjuvant chemotherapy
Number of patients enrolled: Screened 350 Enrolled 314
- Conditions
- Gall Bladder Cancers
- Being tested
- Gemcitabine, Cisplatin, Chemoradiation, PETCECT, Laparoscopy
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemcite, Gemzar
Those randomized to systemic chemotherapy alone will proceed to receive Chemotherapy Gemcitabine gemcitabine 1000 mg/m2delivered day 1 and 8 every 3 weeks for 4 cycles
CisplatinDrug
Also called Cytoplat
Inj. cisplatin 25 mg/m2 delivered. day 1 and 8 every 3 weeks for 4 cycles
ChemoradiationRadiation
Also called Intensity modulated radiotherapy
Radiotherapy will be for 5 weeks and will be given only in the study arm. The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2).
PETCECTProcedure or surgery
Also called PET scan
All the patients will undergo PETCECT to rule out metastatic disease
LaparoscopyProcedure or surgery
Also called Diagnostic laparoscopy
Patients will be subjected to staging laparoscopy with 16b1 lymph node biopsy to rule out metastatic disease.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy arm | Active comparator | Post staging laparoscopy, all patients will receive chemotherapy using Injection Gemcitabine 1000 mg/m2 delivered day 1 and 8 every 3 weeks.
In addition, Injection Cisplatin 25 mg/m2 for and 4 cycles week 1 to week 11. Receives: Drug: Gemcitabine; Drug: Cisplatin; Procedure: PETCECT; Procedure: Laparoscopy |
| Chemoradiation arm | Experimental | Post staging laparoscopy in Experimental arm The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2). Radiotherapy will be for 5 weeks which will be followed by 2 cycles of chemotherapy with Injection Gemcitabine (Gemcite,Gemzar) 1000 mg/m2 delivered day 1 and 8 every 3 weeks and cisplatin (Cisplat, Cytoplatin) 25 mg/m2from week 7 to week 11.
During week 12-13 patients will undergo repeat PETCECT scan. If the scan shows partial or good response then patients will be evaluated for surgery. Surgery if possible will be done between weeks 13-15. In case of inoperable disease patients will receive further chemotherapy Receives: Drug: Gemcitabine; Drug: Cisplatin; Radiation: Chemoradiation; Procedure: PETCECT; Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
To compare the Overall survival between the patients treated with neoadjuvant chemotherapy alone vs. patients treated with neoadjuvant chemoradiation. Overall survival will be calculated from the date of randomization to the date of death
Measured: 6 years
Secondary outcomes (4)
Surgical resection rate
R0 surgical resection rate would be compared in patients who undergo complete resection.
Measured: 6 years
Progression free survival
Progression free survival between the two groups. survival will be calculated from the date of randomization to the date of progression whether local or distal.
Measured: 6 years
Number of participants with treatment related serious adverse events
Adverse events are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events are considered to be related to treatment if the Investigator deems them to be either possibly, probably, or definitely related to treatment Acute toxicities will be measured within 12 weeks of completeion of neoadjuvant Radiotherapy or Chemotherapy
Measured: From the start of treatment until 30 days after the end of treatment, up to approximately 14 months
Deterioration free rate of quality of life (QOL) scores at baseline and three monthly
QOL questionnaires will be applied to patients at baseline and every 12 weeks for a maximum of 12 months. The secondary endpoint will be analysed at the end of the study. FACT (Functional Assessment of Cancer Therapy) -Hep (Hepatic) version 4 will be used to assess quality of life for all patients. It will be assessed at baseline then at the completion of neoadjuvant treatment thereafter 3 monthly at every follow up
Measured: Upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start6 Sep 2016
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gall Bladder CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reena Engineer, Tata Memorial Hospital
- Investigators
- Reena Engineer, MBBS MD, Principal investigator, Professor and Radiation oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867865
- Sponsor's protocol ID
- 1652
- Acronym
- POLCAGB
- Status last verified
- Jan 2025
- First submitted
- 29 Jul 2016
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Engineer R, Patkar S, Lewis SC, Sharma AD, Shetty N, Ostwal V, Ramaswamy A, Chopra S, Agrawal A, Patil P, Mehta S, Goel M. A phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol. BMJ Open. 2019 Jun 27;9(6):e028147. doi: 10.1136/bmjopen-2018-028147.
PubMed 31253621
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Therapy Preoperative Chemotherapy Versus Chemoradiotherapy in Locally Advanced Gall Bladder Cancers
- ClinicalTrials.gov ID
- NCT02867865
- Acronym / sponsor ID
- POLCAGB / 1652
- Conditions
- Gall Bladder Cancers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. Gallbladder cancer is not common western world and thus there is lack of evidence regarding the impact of neoadjuvant or concurrent chemo-radiation in this cancer.Use of neoadjuvant treatment with chemotherapy alone or chemoradiotherapy has shown to downsize these tumors to safely undergo R0 resection in few published studies. Also if the patients develop distant metastasis during this neoadjuvant therapy they can be spared of unnecessary surgery.
In a pilot study of 28 patients by Engineer et al conducted at Tata Memorial centre treated with neoadjuvant concurrent chemoradiation the investigators could achieve R0 resectability rate 0f 47% with a median overall survival (OAS) and progression free survival (PFS) of 35 and 20 months for the patients undergoing R0 resection.
In this study the investigators intend to compare the effects of using neoadjuvant chemotherapy alone vs. neoadjuvant chemoradiation and chemotherapy for locally advanced gall bladder cancers in terms of down staging and overall survival.
Detailed description
Introduction:
Adenocarcinoma of the gallbladder (GBCA) is the most common malignancy of the biliary tract and its incidence is alarmingly high in the Indian subcontinent. Complete surgical excision is the standard of care for both gallbladder and pancreatic cancers. Unfortunately, majority of these cancers are diagnosed at an advanced, inoperable stage and only 10-30% of the patient present with resectable disease.
Gall bladder cancers which are T3/T4 with liver infiltration, with or without visceral/vascular infiltration or having large local lymph node metastases; in the absence of distant metastases are generally considered as locally advanced. There prognosis in terms of resectability and survival remains dismal in most of the reports.
Even with aggressive surgery like extrahepatic bile duct resection or pancreaticoduodenectomy the 5 year survival rate for stage III disease ranges 30% to 42% in best of the reports. But these results are often not reproducible.
Locally advanced Gall bladders cancers not amenable for curative resection are often treated with chemotherapy alone which is the current standard of care. Randomized trials have shown survival benefit with combination chemotherapy in gallbladder cancers. In a randomized trial combination chemotherapy of Gemcitabine and cisplatin was superior to Gemcitabine chemotherapy alone and local tumor response in terms of partial downsizing or stable disease was achieved in 81% of cases. With Gemcitabine and Cisplatin based Neoadjuvant chemotherapy (NACT) some locally advanced GB cancers do get downstaged to undergo resection. Recent publication from Tata Memorial Centre, where NACT alone was given which resulted in surgical resection rate of 43% median OAS and PFS being 13 months and 8 months.
Study methodology:
All patients with diagnosis of non metastatic locally advanced Gall bladder cancers who fulfill the study eligibility criteria will be evaluated for study participation and will undergo Positron emission tomography and contrast enhanced computerized tomography (PETCECT) scan and staging laparoscopy to rule out metastatic disease. Patients will undergo upfront randomization into one of the study arms.
A proportion of patients are expected to have jaundice or cholangitis at presentation. At study inclusion there should be no clinical evidence of active cholangitis or unresolved biliary obstruction. Liver Function Tests, Renal Function Tests and CA 19-9 within 4 weeks of treatment initiation.
Systemic Chemotherapy arm (Standard Arm or Arm A)
Those randomized to NACT will proceed to receive systemic gemcitabine 1000 mg/m2delivered day 1 and 8 every 3 weeks and cisplatin 25 mg/m2 for and 4 cycles (week 1- week 11).
Chemoradiation arm (Study Arm or Arm B)
The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2). Radiotherapy will be for 5 weeks which will be followed by 2 cycles of chemotherapy (week 7 to week 11)
These radiotherapy (RT) doses have found to be safe in the investigators pilot study.
During week 12-13 patients will undergo repeat PETCECT scan. If the scan shows partial or good response then patients will be evaluated for surgery. Surgery if possible will be done between weeks 13-15. In case of inoperable disease patients will receive further chemotherapy. With locally progressive/systemic disease on chemotherapy patients may be considered for second line palliative chemotherapy or best supportive care. The use of radical dose chemoradiation is not allowed on disease progression in the systemic chemotherapy arm. However palliative radiation may be used.
Surgery
Surgical procedure will be en-bloc resection including cholecystectomy with a liver wedge excision and periportal lymph node clearance. Nodal clearance from station number 8, 12, 13 with sampling of inter aortocaval node will be done. Extrahepatic biliary excision or additional organ excision will be done as per the discretion of operating surgeon.
Post Surgery all patients will receive additional adjuvant chemotherapy
Number of patients enrolled: Screened 350 Enrolled 314
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy arm | Active comparator | Drug: Gemcitabine, Drug: Cisplatin, Procedure: PETCECT, Procedure: LaparoscopyPost staging laparoscopy, all patients will receive chemotherapy using Injection Gemcitabine 1000 mg/m2 delivered day 1 and 8 every 3 weeks. In addition, Injection Cisplatin 25 mg/m2 for and 4 cycles week 1 to week 11. |
| Chemoradiation arm | Experimental | Drug: Gemcitabine, Drug: Cisplatin, Radiation: Chemoradiation, Procedure: PETCECT, Procedure: LaparoscopyPost staging laparoscopy in Experimental arm The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2). Radiotherapy will be for 5 weeks which will be followed by 2 cycles of chemotherapy with Injection Gemcitabine (Gemcite,Gemzar) 1000 mg/m2 delivered day 1 and 8 every 3 weeks and cisplatin (Cisplat, Cytoplatin) 25 mg/m2from week 7 to week 11. During week 12-13 patients will undergo repeat PETCECT scan. If the scan shows partial or good response then patients will be evaluated for surgery. Surgery if possible will be done between weeks 13-15. In case of inoperable disease patients will receive further chemotherapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- -> 2 cm but < 5 cm liver invasion
- Radiological involvement of antropyloric region of stomach, duodenum, hepatic flexure of colon or small intestine, but without infiltration of the mucosa on endoscopy.
- Type I/II invasion -Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct) causing obstructive jaundice
- Radiological suspicion of lymph node involvement N1 {stations 8, 12, 13) Hepatic artery (Station 8), hepatoduodenal ligament (Station 12), retropancreatic/retroduodenal (Station 13) i.e. size>1cm in short axis, round in shape, and heterogenous enhancement on PET scan.
- Vascular involvement : impingement/ involvement (<180 degree angle) of one or more of the following blood vessels common hepatic artery/ right hepatic artery/main portal vein/right portal vein (stage III disease)
Key exclusion criteria (4 listed)
- Resectable disease
- Evidence of distant metastasis (Liver, Lung, peritoneum, port site etc)
- Involving major part of the liver precluding restriction of full RT doses
- Received any prior radiation or chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: Gemcite, GemzarThose randomized to systemic chemotherapy alone will proceed to receive Chemotherapy Gemcitabine gemcitabine 1000 mg/m2delivered day 1 and 8 every 3 weeks for 4 cycles | Drug | Chemoradiation arm, Chemotherapy arm |
| CisplatinAlso: CytoplatInj. cisplatin 25 mg/m2 delivered. day 1 and 8 every 3 weeks for 4 cycles | Drug | Chemoradiation arm, Chemotherapy arm |
| ChemoradiationAlso: Intensity modulated radiotherapyRadiotherapy will be for 5 weeks and will be given only in the study arm. The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2). | Radiation | Chemoradiation arm |
| PETCECTAlso: PET scanAll the patients will undergo PETCECT to rule out metastatic disease | Procedure or surgery | Chemoradiation arm, Chemotherapy arm |
| LaparoscopyAlso: Diagnostic laparoscopyPatients will be subjected to staging laparoscopy with 16b1 lymph node biopsy to rule out metastatic disease. | Procedure or surgery | Chemoradiation arm, Chemotherapy arm |
Primary outcome
Overall Survival
Time frame: 6 years
To compare the Overall survival between the patients treated with neoadjuvant chemotherapy alone vs. patients treated with neoadjuvant chemoradiation. Overall survival will be calculated from the date of randomization to the date of death
4 secondary outcomes
Surgical resection rate
Time frame: 6 years
Progression free survival
Time frame: 6 years
Number of participants with treatment related serious adverse events
Time frame: From the start of treatment until 30 days after the end of treatment, up to approximately 14 months
Deterioration free rate of quality of life (QOL) scores at baseline and three monthly
Time frame: Upto 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 31253621Engineer R, Patkar S, Lewis SC, Sharma AD, Shetty N, Ostwal V, Ramaswamy A, Chopra S, Agrawal A, Patil P, Mehta S, Goel M. A phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol. BMJ Open. 2019 Jun 27;9(6):e028147. doi: 10.1136/bmjopen-2018-028147.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reena Engineer, MBBS MD principal investigator
Professor and Radiation oncologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gemcitabine, Cisplatin and Chemoradiation in people with Gall Bladder Cancers, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.