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NCT Number: NCT01118897

Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

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

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Key information

Conditions

Pancreatic Neoplasms Malignant Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Malignant Neoplasm of Gall Bladder Non-resectable Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tomotherapy

Radiation

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Response to CTRT

    Time frame: 3 months

    All patients will undergo PET CT scan for radiological evaluation of response at 6 weeks post CTRT

  2. R0 resection rate

    Time frame: 6 weeks

    All patients will be jointly evaluated for surgery 6 weeks post chemoradiation

  3. Locoregional control

    Time frame: 3 years

  4. Overall survival

    Time frame: 3 years

    At the median follow up of 3 years the 5 year overall survival rate would be assesed

Sponsors and collaborators

Lead sponsor

Tata Memorial Hospital

Other Gov

Registry information

Official study title

Concurrent Chemo-radiation Using Tomotherapy Based IMRT in Locally Advanced Gallbladder and Pancreatic Cancers :A Phase II Study

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 7, 2010
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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