Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
Recruitment status was Recruiting
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Purpose
SUMMARY
PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase feasibility study
SPECIFIC OBJECTIVES:
Primary To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.
Secondary
- To study clinical benefit response
- To assess the acute and late toxicities associated with this treatment
- To assess radiologic and metabolic response to treatment.
- To assess the resectability rate with microscopic negative margin (R0).
- To study the locoregional control and progression free survival (PFS).
- To measure the Quality of life (QOL) scores.
DESIGN: Feasibility 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
| Condition | Intervention | Phase |
|---|---|---|
|
Gallbladder Neoplasms and Pancreatic Neoplasms |
Radiation: Tomotherapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Feasibility Study |
- To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
- Response to CTRT [ Time Frame: 3 months ] [ Designated as safety issue: No ]All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
-
Radiation: Tomotherapy
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion criteria
- 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.
Contacts and Locations| Contact: Reena Engineer, MD | +912224177165 | reena_engineer@rediffmail.com |
| Contact: ShyamKishore Shrivastava, MD | +912221477163 | shrivastavask@tmc.gov.in |
| India | |
| Tata Memorial Centre | Recruiting |
| Mumbai, Maharashtra, India, 400012 | |
| Principal Investigator: | Reena Engineer, MD | Tata Memorial Centre |
More Information
No publications provided
| Responsible Party: | Dr Reena Engineer, Tata Memorial Centre |
| ClinicalTrials.gov Identifier: | NCT01118897 History of Changes |
| Other Study ID Numbers: | IRB 599 |
| Study First Received: | May 3, 2010 |
| Last Updated: | May 6, 2010 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Tata Memorial Hospital:
|
Gall bladder Pancreatic cancers Tomotherapy |
Additional relevant MeSH terms:
|
Neoplasms Gallbladder Neoplasms Pancreatic Neoplasms Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site |
Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013