Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reena Engineer, Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01118897
First received: May 3, 2010
Last updated: August 5, 2015
Last verified: May 2010

May 3, 2010
August 5, 2015
December 2008
January 2013   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability
Same as current
Complete list of historical versions of study NCT01118897 on ClinicalTrials.gov Archive Site
  • 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
  • R0 resection rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    All patients will be jointly evaluated for surgery 6 weeks post chemoradiation
  • Locoregional control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    At the median follow up of 3 years the 5 year overall survival rate would be assesed
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
Not Provided
Not Provided
 
Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers
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

SPECIFIC OBJECTIVES:

Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.

Secondary

  1. To assess the resectability rate with microscopic negative margin (R0).
  2. To assess the acute and late toxicities (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
  3. To study the locoregional control in the patients undergoing R0 resection
  4. 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

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Neoplasms Malignant
  • Malignant Neoplasm of Gall Bladder Non-resectable
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.

Experimental: Neoadjuvant chemoradiation
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
Intervention: Radiation: Tomotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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.
  2. Biopsy proven adenocarcinoma
  3. KPS >= 70
  4. Age >18 years
  5. Medically fit for chemotherapy
  6. Normal hematological, renal and hepatic function (Serum Bilirubin<3mg/dl)
  7. No prior history of treatment with radiation or chemotherapy.
  8. Patient willing and reliable for follow-up.

Exclusion criteria

  1. Any other malignancy in any site.
  2. Expected survival < 3months.
  3. Severe co-morbid conditions ( Severe cardiac disorder, severe bronchial asthma, severely compromised liver function, psychological disorder)
  4. Malignant ascitis.
  5. Distant metastases by clinical examination or by imaging/whole bodyPET scan.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01118897
IRB 599
Yes
Reena Engineer, Tata Memorial Hospital
Tata Memorial Hospital
Not Provided
Principal Investigator: Reena Engineer, MD Tata Memorial Centre
Tata Memorial Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP