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Therapy used for Carcinoma Gallbladder after Surgery

Adjuvant Chemotherapy versus Adjuvant Chemotherapy/Radiotherapy for Carcinoma Gallbladder- A Randomized Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011296
Enrollment
50
Registered
2018-01-12
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- Operated for Carcinoma Gallbladder

Interventions

Intervention1: Adjuvant concurrent chemoradiotherapy: External beam radiotherapy (50.4Gy @ 1.8Gy for 28 fraction ). Radiation area will include GB fossa
adjacent liver and regional lymphnodes. Chemotherapy given concurently will be injection fluracil 750mg/m2 on day 1-5 and last 5 days of radiotherapy concurrently Control Intervention1: Adjuvant chemo

Sponsors

Dr Shivendra Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All resectable Ca GB patients who have undergone R0 resection for Ca GB; Those who have not recieved neoadjuvant treatment; those who donot have stage IV disease.

Exclusion criteria

Exclusion criteria: Metastatic disease; R1 resection for Ca GB; Stage IVb disease; Those who have recieved neoadjuvant treatment; Refused consent for adjuvant treatment.

Design outcomes

Primary

MeasureTime frame
Overall survival; Recurrence free survivalTimepoint: 6 month; 1 year; 3 year; 5 year—

Secondary

MeasureTime frame
Pattern of recurrence; Toxicity/Complication of chemotherapy and ChemoradiotherapyTimepoint: in 30 days of completion of therapy;6month; 1 year; 3 year; 5 year.—

Countries

India

Contacts

Public ContactDr Shivendra Singh

Rajiv Gandhi Cancer Institute and Research Centre

singh.shivendra@rgcirc.org9818975024

Outcome results

None listed

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