Intensity modulated radiation therapy in Patients with locally advanced inoperable gall bladder and pancreatic cancer

Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers :A feasibility study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/08/007129

Enrollment

Registered

2016-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Gall Bladder Cancer and Pancreatic Cancer

Interventions

Intervention1: Radiation: Tomotherapy concurrent CTRT operable: Radiotherapy 57-60 Gy in 25 fraction to PTV boost (SIBV - simultaneous integrated Boost volume) (2.3-2.4Gy/Fr) Concurrent chemotherapy

Eligibility

Inclusion criteria

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), SMV not amenable to resection for pancreatic cancers. Deep hilar invasion precluding R0 resection, vascular encasement or extensive duodenal infiltration for gall bladder cancers Biopsy proven adenocarcinoma KPS more than or equal to 70 Medically fit for chemotherapy Normal hematological, renal and hepatic function (Serum Bilirubin No prior history of treatment with radiation or chemotherapy Patient willing and reliable for follow-up

Exclusion criteria

Exclusion criteria: Any other malignancy in any site Expected survival 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

Design outcomes

Primary

Measure	Time frame
To assess the feasibility of concurrent chemo-radiation with dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancerTimepoint: 3 years	—

Secondary

Measure	Time frame
To study clinical benefit response To assess the acute and late toxicities associated with this treatment To assess radiological and metabolic response to treatment To assess the resectability rate with microscopic negative margin (R0) To study the locoregional control rates and progression free survival (PFS) To measure the Quality of life (QOL) scores in these patientsTimepoint: 3 years	—

Countries

India

Contacts

Public ContactReena Engineer

Tata Memorial Centre

reena_engineer@rediffmail.com9820128662

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026