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Study on role of chemoradiation in biliary tract cancer

Outcomes of Definitive Chemoradiotherapy in Inoperable, Non-Metastatic Biliary tract Carcinoma: A Single Institution Prospective Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094841
Enrollment
30
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder Health Condition 2: C249- Malignant neoplasm of biliary tract, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Nil: Nil Intervention5: Nil: Nil

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven carcinoma of biliary tract, deemed unresectable but non-metastatic based on multidisciplinary evaluation upfront or post Neo-adjuvant chemotherapy. 2. Age 18 or above 3. ECOG Performance Status 0,1,2 4. Written informed consent obtained 5. Adequate organ function (Hematologic- Hb- more than 9gm per dL ,TLC more than 4000 per dL, hepatic = TB less than 3, and renal parameters within institutional limits) 7. Patients planned for definitive concurrent chemo radiotherapy (Def-CTRT) 8. Imaging-confirmed non-metastatic status (CT/MRI and PET-CT if needed)

Exclusion criteria

Exclusion criteria: 1. Histology other than carcinoma (e.g. sarcoma, lymphoma) 2. Prior RT to upper abdomen 3. Evidence of distant metastasis 4. History of another malignancy within last 5 years 5. Uncontrolled concurrent illness (e.g., active infection, uncontrolled diabetes, tuberculosis) 6. Pregnancy or lactation 7. Patients with obstructive jaundice not relieved or unfit for biliary drainage 8. Presence of ascites or ECOG more than 2

Design outcomes

Primary

MeasureTime frame
Assess progression free survival (PFS) in patients with unresectable, non-metastatic biliary tract cancer treated with CTRT.Timepoint: 12 months—

Secondary

MeasureTime frame
Evaluate overall survival (OS)Timepoint: 12 months;Analyze the toxicity profile of concurrent chemo radiotherapy using CTCAE criteria.(Version 5.0)Timepoint: 12 months;Explore patterns of failure (local, regional, distant) post-CTRTTimepoint: 12 months—

Countries

India

Contacts

Public ContactPrashanth Giridhar

Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi

lincoln@mpmmcc.tmc.gov.in7735661666

Outcome results

None listed

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