Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gallbladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Pancreatic Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

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

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.

Tomotherapy

Reena Engineer, MD

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.

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

Number of Patients with Grade III adverse Events as a Measure of Safety and Tolerability

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

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

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

Tata Memorial Hospital

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Stomach Neoplasms

Lung Neoplasms

Melanoma

Glioblastoma

Death

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Stomach Diseases

Stomach Cancer

Neuroepithelioma

Oncologists trained using OncoTalk to have Goals of Care discussions.

Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

GoC intervention

Nina Bickell, MD, MPH

The goal of this study is to increase and improve Goals of Care discussions for advanced cancer patients by training medical oncologists to conduct these discussions. The investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of treatment in line with preferences, use of aggressive treatment, and oncologist communication skill.

Among advanced cancer patients, discussions about prognosis, goals of care (GoC) and end-of-life preferences improve quality of life of patients and reduce rates of hospital and ICU admission. Yet, few patients know their chemotherapy treatments will not cure their disease despite nearly all wishing to receive information- good \& bad. Currently, 37% of advanced cancer patients have GoC clarifying discussions and when they do, it is often in the last 2 months of life when symptoms are uncontrollable and oncologists have no other treatments to offer. These discussions do not usually happen with the patient's personal oncologist. Current efforts to teach oncologists such skills are impractical, requiring a lot of time away from their office practice and do not take into account job pressures.

The goal of this study is to increase and improve GoC discussions for advanced cancer patients by training medical oncologists to conduct these discussions and evaluate its effects on patient satisfaction, receipt of care in line with preferences, aggressive care utilization, and oncologist communication skill.

The investigators will recruit 280 patients of which half will come from intervention doctors and the other from the control doctors. The investigators will train randomly selected oncologists to conduct GoC discussion. Patients will be surveyed at baseline within days of their GOC visit and at 6 months. Oncologists will be audio-taped at baseline and after training is complete to assess practice and skill to conduct GoC discussions.

Primary outcomes include patient reported conduct of and satisfaction with GoC discussion. Secondary outcomes include oncologist communication skills, feasibility of performing GoC in the outpatient setting, receipt of care in line with preferences, use of hospice, chemotherapy or ICU in the last 30 days of life.

Improving Goals of Care Discussion in Advanced Cancer Patients

Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions

Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.

Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.

Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients.

Patient-Centered Outcomes Research Institute

Icahn School of Medicine at Mount Sinai

Adverse events were not monitored/assessed

Patients given OncoTalk GoC intervention

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Patients - GoC Intervention

Prospective control group where no intervention was given.

Patients - Usual Care

Oncologists - GoC Intervention

Oncologists not trained using OncoTalk to have Goals of Care discussions.

Oncologists - Usual Care

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Data was collected for patient participants only

Radhi Yagnik

Oncologist - GoC Intervention

Data from patient participants only. Data not collected from Oncologists

Number of Participants Who Perceived Increased Goals of Care Discussions

Patients given OncoTalk GoC intervention.

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Data collected for patient participants only

Number of Patients Perception of Improved Goals of Care Discussions

Oncologists trained using OncoTalk to have Goals of Care discussions.

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Participants represented are the oncologist's. Data collected for the oncologists only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers	NCT01118897	Pancreatic Neop... Malignant Neopl...	Tomotherapy	18 Years - 75 Years	Tata Memorial Hospital
Improving Goals of Care Discussion in Advanced Cancer Patients	NCT02374255	Primary Stage I... Esophageal Colorectal Canc... Glioblastoma Cancer of Stoma... Cancer of Pancr... Melanoma Head or Neck Ca... Stage III Stage IV Lung Cancers Pancreatic Canc...	GoC interventio...	21 Years -	Icahn School of Medicine at Mount Sinai
Improving Goals of Care Discussion in Advanced Cancer Patients	NCT02374255	Primary Stage I... Esophageal Colorectal Canc... Glioblastoma Cancer of Stoma... Cancer of Pancr... Melanoma Head or Neck Ca... Stage III Stage IV Lung Cancers Pancreatic Canc...	GoC interventio...	21 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for pancreatic cancers