Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

NCT01118897 | Completed Phase 1 DMC

• 1 other identifier: IRB 599
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Neoplasms Malignant; Malignant Neoplasm of Gall Bladder Non-resectable

Keywords

Gall bladder; Pancreatic cancers; Tomotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  3 Years

Secondary Outcomes (4)

• Response to CTRT

  3 months

• R0 resection rate

  6 weeks

• Locoregional control

  3 years

• Overall survival

  3 years

Study Arms (1)

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

Radiation: Tomotherapy

Interventions

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.

Neoadjuvant chemoradiation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Reena Engineer, MD

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 7, 2010
• Study Start: December 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2015

Record last verified: 2010-05

Locations

IN (1)