Pancreatic Neoplasms MalignantPhase 1/2NCT01118897
Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
A Phase 1/2 study testing Tomotherapy in people with Pancreatic Neoplasms Malignant and Malignant Neoplasm of Gall Bladder Non-resectable, run by Tata Memorial Hospital at 1 site in India.
Trial summary
SUMMARY PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase II study SPECIFIC OBJECTIVES: Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers. Secondary 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasms Malignant, Malignant Neoplasm of Gall Bladder Non-resectable
- What is being tested?
- Tomotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2008to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inoperable locally advanced gall bladder and pancreatic cancer by virtue of vascular encasement of superior mesenteric artery (SMA), celiac artery, hepatic artery, portal vein (PV) or deep hilar invasion precluding R0 resection.
- Biopsy proven adenocarcinoma
- KPS >= 70
- Age >18 years
- Medically fit for chemotherapy
- Normal hematological, renal and hepatic function (Serum Bilirubin<3mg/dl)
- No prior history of treatment with radiation or chemotherapy.
- Patient willing and reliable for follow-up.
Who cannot join
- Any other malignancy in any site.
- Expected survival < 3months.
- Severe co-morbid conditions ( Severe cardiac disorder, severe bronchial asthma, severely compromised liver function, psychological disorder)
- Malignant ascitis.
- Distant metastases by clinical examination or by imaging/whole bodyPET scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study
SUMMARY
PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase II study
Read more
SPECIFIC OBJECTIVES:
Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.
Secondary
- To assess the resectability rate with microscopic negative margin (R0).
- To assess the acute and late toxicities (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
- To study the locoregional control in the patients undergoing R0 resection
- To study overall survival
DESIGN: Phase II study
STUDY POPULATION: All patients of age >18 years years diagnosed with non metastatic locally advanced inoperable gall bladder and pancreatic cancer
STUDY SIZE: 60 patients
METHODOLOGY: Sixty cases will be screened and taken for study if eligible after taking the informed consent.
Patients will receive radiotherapy using Tomotherapy based IMRT with concurrent chemotherapy Gemcitabine weekly. The response will evaluated at 6 weeks post chemoradiation and if operable will undergo surgery, if still inoperable or metastatic will receive palliative chemotherapy.
PROJECT PERIOD:
Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
Read the detailed description
In both gall bladder and pancreatic cancer surgery is the main stay of treatment, but majority of these tumors are inoperable by virtue of adjacent organ infiltration. In this study, inoperable gallbladder and pancreatic cancer patients will be treated with high precision radiotherapy using Tomotherapy delivering higher dose of radiation along with chemotherapy. It is expected that this high dose precise radiotherapy along with chemotherapy will lead to good symptom relief and make some of these tumors operable.
- Being tested
- Tomotherapy
- Keywords
- Gall bladder, Pancreatic cancers, Tomotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TomotherapyRadiation
Radiotherapy 57-60 Gy in 25 fraction to PTV boost (SIBV - simultaneous integrated Boost volume) (2.3-2.4Gy/Fr)
Concurrent chemotherapy Weekly concurrent CT schedule: Inj Gemcitabine 300 mg/m2 weekly during RT.
Surgery: All patients will be evaluated for surgery in the joint clinic by surgeons and other treating physicians at 6-8 weeks post CT-RT. PET CT Scan will be used as the imaging modality. Patients suitable for R0 resection will be planned for surgery. Inoperable patients will be treated with palliative chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoradiation | Experimental | All patients will receive concurrent chemoradiation. Chemotherapy will consist of Inj. Gemcitabine 300mg/mt2 weekly throughout the course of Radiotherapy. Radiotherapy will be delivered using Tomotherapy to a dose of 57Gy/25# over 5 weeks Receives: Radiation: Tomotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers
Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
Measured: 3 Years
Secondary outcomes (4)
Response to CTRT
All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT
Measured: 3 months
R0 resection rate
All patients will be jointly evaluated for surgery 6 weeks post chemoradiation
Measured: 6 weeks
Locoregional control
Measured: 3 years
Overall survival
At the median follow up of 3 years the 5 year overall survival rate would be assesed
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startDec 2008
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neoplasms MalignantStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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, MD, Principal investigator, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118897
- Sponsor's protocol ID
- IRB 599
- Status last verified
- May 2010
- First submitted
- 3 May 2010
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study
- ClinicalTrials.gov ID
- NCT01118897
- Acronym / sponsor ID
- IRB 599
- Keywords
- Gall bladder, Pancreatic cancers, Tomotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Dec 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 May 2010 (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.
SUMMARY
PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase II study
SPECIFIC OBJECTIVES:
Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.
Secondary
- To assess the resectability rate with microscopic negative margin (R0).
- To assess the acute and late toxicities (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
- To study the locoregional control in the patients undergoing R0 resection
- To study overall survival
DESIGN: Phase II study
STUDY POPULATION: All patients of age >18 years years diagnosed with non metastatic locally advanced inoperable gall bladder and pancreatic cancer
STUDY SIZE: 60 patients
METHODOLOGY: Sixty cases will be screened and taken for study if eligible after taking the informed consent.
Patients will receive radiotherapy using Tomotherapy based IMRT with concurrent chemotherapy Gemcitabine weekly. The response will evaluated at 6 weeks post chemoradiation and if operable will undergo surgery, if still inoperable or metastatic will receive palliative chemotherapy.
PROJECT PERIOD:
Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of data : 1 year
STUDY SITE: Tata memorial centre
Detailed description
In both gall bladder and pancreatic cancer surgery is the main stay of treatment, but majority of these tumors are inoperable by virtue of adjacent organ infiltration. In this study, inoperable gallbladder and pancreatic cancer patients will be treated with high precision radiotherapy using Tomotherapy delivering higher dose of radiation along with chemotherapy. It is expected that this high dose precise radiotherapy along with chemotherapy will lead to good symptom relief and make some of these tumors operable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoradiation | Experimental | Radiation: TomotherapyAll patients will receive concurrent chemoradiation. Chemotherapy will consist of Inj. Gemcitabine 300mg/mt2 weekly throughout the course of Radiotherapy. Radiotherapy will be delivered using Tomotherapy to a dose of 57Gy/25# over 5 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Inoperable locally advanced gall bladder and pancreatic cancer by virtue of vascular encasement of superior mesenteric artery (SMA), celiac artery, hepatic artery, portal vein (PV) or deep hilar invasion precluding R0 resection.
- Biopsy proven adenocarcinoma
- KPS >= 70
- Age >18 years
- Medically fit for chemotherapy
Key exclusion criteria (5 listed)
- Any other malignancy in any site.
- Expected survival < 3months.
- Severe co-morbid conditions ( Severe cardiac disorder, severe bronchial asthma, severely compromised liver function, psychological disorder)
- Malignant ascitis.
- Distant metastases by clinical examination or by imaging/whole bodyPET scan.
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 |
|---|---|---|
| TomotherapyRadiotherapy 57-60 Gy in 25 fraction to PTV boost (SIBV - simultaneous integrated Boost volume) (2.3-2.4Gy/Fr) Concurrent chemotherapy Weekly concurrent CT schedule: Inj Gemcitabine 300 mg/m2 weekly during RT. Surgery: All patients will be evaluated for surgery in the joint clinic by surgeons and other treating physicians at 6-8 weeks post CT-RT. PET CT Scan will be used as the imaging modality. Patients suitable for R0 resection will be planned for surgery. Inoperable patients will be treated with palliative chemotherapy. | Radiation | Neoadjuvant chemoradiation |
Primary outcome
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers
Time frame: 3 Years
Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
4 secondary outcomes
Response to CTRT
Time frame: 3 months
R0 resection rate
Time frame: 6 weeks
Locoregional control
Time frame: 3 years
Overall survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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, MD principal investigator
Tata Memorial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tomotherapy in people with Pancreatic Neoplasms Malignant and Malignant Neoplasm of Gall Bladder Non-resectable, 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 7 Aug 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2015.