a randomized controlled trial comparing modified gemcitabine+oxaliplatin(mGEMOX) to gemcitabine+cisplatin in management of unresectable gall bladder cancer.

Conditions

Health Condition 1: null- management of gall bladder cancer.

Sharma A, Kalyan Mohanti B, Pal Chaudhary S, Sreenivas V, Kumar Sahoo R, Kumar Shukla N, Thulkar S, Pal S, Deo SV, Pathy S, Ranjan Dash N, Kumar S, Bhatnagar S, Kumar R, Mishra S, Sahni P, Iyer VK, Raina V.

2019-11-1448 citations

10.1016/j.ejca.2019.10.004

Final results of a phase III randomized controlled trial comparing modified gemcitabine + oxaliplatin (mGEMOX) to gemcitabine+ cisplatin in management of unresectable gall bladder cancer (GBC).

Atul Sharma, Nootan Kumar Shukla, Surendra Pal Chaudhary, Ranjit Kumar Sahoo, BK Mohanti et al. (18 authors)

Journal of Clinical Oncology2016-05-2010 citations

10.1200/jco.2016.34.15_suppl.4077

A randomized controlled trial comparing modified gemcitabine plus oxaliplatin (mGEMOX) to gemcitabine plus cisplatin in management of unresectable gall bladder cancer.

Atul Sharma, Surendra Pal Chaudhary, N.K. Shukla, BK Mohanti, S. V. S. Deo et al. (11 authors)

Journal of Clinical Oncology2014-05-201 citations

10.1200/jco.2014.32.15_suppl.tps4152

Interventions

Intervention1: mGEMOX vs mGEMCIS: Arm A- mGEMOX Inj Oxaliplatin 80 mg/m2 2 hours infusion in Dextrose 5% Day 1 and 8 Inj Gemcitabine 900 mg/m2 IV 30 minutes infusion day1 and 8 Cycles will be repea

Eligibility

Inclusion criteria

Inclusion criteria: a. Histologically proven cases of adenocarcinoma of gall bladder b. Subjects having measurable disease which is considered unresectable/metastatic c. Written consent is obtained d. ECOG Performance status e. Age >18 years f. Adequate bone marrow functions reflected as Hb  10gm/dl, TLC 4,000/cmm ( ANC1,500/cmm), and Platelets 1,00,000/cmm) g. Serum creatinine  1.8 mg% h. Serum bilirubin 3 mg% i. Liver enzymes (SGOT and SGPT) within 3 times the upper normal limit j. Prior adjuvant chemotherapy with 5FU/folinic acid allowed provided there is more than 6 months of gap between last chemotherapy and recurrence k. No prior exposure to oxaliplatin or gemcitabine l. At least 4 weeks since prior radiotherapy to tumor site m. Prior surgical resection before recurrence is allowed

Exclusion criteria

Exclusion criteria: a. Women of reproductive age group not practicing contraception b. Lactating and pregnant women c. Patients who are on other investigational drugs d. Patient unwilling to give written informed consent e. History of previous carcinoma in last 5 yrs.

Design outcomes

Primary

Measure	Time frame
3.1 Primary Objectives: Overall survival in subjects receiving mGEMOX or GEMCIS regimen.Timepoint: nil	—

Secondary

Measure	Time frame
3.2 Secondary objectives: a. Comparison of progression free survival in 2 groups. b. Response rates in two groups c. Identification of genes predictive of responses in a subset of patients. d. Evaluation of role of PET CT Timepoint: nil	—

Countries

India

Contacts

Public ContactDR ATUL SHARMA

AIIMS

atul1@hotmail.com01126589490

Outcome results

None listed