Perioperative Gemcitabine based chemotherapy vs surgery and adjuvant CAPECITABINE and chemo-radiation in operable GBC

Phase 3

• Conditions: Health Condition 1: C23- Malignant neoplasm of gallbladderHealth Condition 2: O- Medical and Surgical

• Registration Number: CTRI/2024/08/072162
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Histologically confirmed adenocarcinoma (FNAC or biopsy) of the

gallbladder

2.No radiological or clinical evidence of metastatic disease and no

evidence of metastatic disease as discovered by on-table evaluation

during definitive surgery

3.Patients presenting with pT3 or/and pN + disease after simple

cholecystectomies who are non-metastatic and still resectable

4.The patients who present with upfront cT3 and or cN+ disease and are

non-metastatic and resectable

5.The patients who present with upfront cT2 and cN+ disease and are

non-metastatic and resectable

6.Operable disease decided in MDT

7.ECOG performance status 0 - 1

8.Patient does not have any contraindications to receive chemotherapy

9.Adequate hematological, hepatic and renal function parameters -

hematological- Hb greater than 80 g/L, ANC greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L.

Liver functions- bilirubin lesser than or equal to 2 x upper limit normal (ULN),

AST/ALT lesser than or equal to 5 x ULN, S. albumin greater than or equal to 2.8 g/L

10.Renal function- Creatinine lesser than or equal to 1.5 ULN, Creatinine clearance greater than or equal to 50 mL/min.

11.Women of childbearing age should have a negative pregnancy test at

the time of randomization and should be willing to use adequate

contraception during the treatment phase of the trial.

Exclusion Criteria

1.Known hypersensitivity or contraindications against gemcitabine,

cisplatin, Nab-Paclitaxel or CAPECITABINE or radiation therapy.

2.Radiological T1 patients will not be included if radiologists are sure

about the cT1 at presentation

3.Clinically significant active coronary heart disease, cardiomyopathy,

valvular heart disease or congestive heart failure, NYHA III-IV,

4.Past or current history of other malignancies not curatively treated and

without evidence of disease for more than 5 years, except for

curatively treated basal cell carcinoma of the skin and in situ

carcinoma of the cervix

5.Other severe internal disease or acute infection

6.Subject pregnant or breast feeding, or planning to become pregnant

within 6 months after the end of treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified