Cisplatin Containing Chemotherapy Regimens in Osteosarcoma and other Solid Tumors.

Phase 3

• Conditions: Health Condition 1: I00- Rheumatic fever without heart involvement

• Registration Number: CTRI/2020/12/030115
• Lead Sponsor: The Terry Fox International Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Inclusion criteria

a)Patients with osteosarcoma and other solid tumors (lung, head and neck region and germ cell tumors) who are planned for Cisplatin at a minimum dose of 75 mg/m2

b)Patients aged 12- 70 years

c)Baseline GFR>= 60ml/min

d)ECOG performance status <= 2

Exclusion Criteria

2.Exclusion Criteria

a)Patients undergoing treatment with nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, amphotericin B, or cephalosporins) or drugs that falsely elevate serum creatinine (sulfonamides) â?°

However, if patients received these drugs in the recent past after an appropriate washout period they can be enrolled which depends upon the half-life of the drugs. Details of drug specific wash out period as per:

Table No 1: Wash out period

Amphotericin Wash out period (4 weeks)

NSAID

Aminoglycosides Wash out period (5 days)

Cyclophosphamide

Sulfonamides

DrugHalf life

Amphotericin15 day

NSAID2-60 hours

Aminoglycosides2-3 hours

Cyclophosphamide3-12 hours

Sulfonamide8-10 hours: normal patient

b.Patients having chronic renal disease with GFR < 60 ml/min Patients who suffer from severe suppression of bone marrow functionality, symptoms may be: extreme tiredness, easy bruising or bleeding, occurrence of infections

c.Patients having hearing impairment

d.Previous history of abdominal radiation

e.Patients receiving concurrent radiotherapy

f.Patients receiving concurrent experimental treatment

g. Fluid retention states like heart, liver or respiratory failure

h.High likelihood of tumor lysis syndrome

i.Presence of structural renal changes on ultrasonography esp. hydronephrosis

j.Pregnant or lactating females.

k.Patient with previous or current diagnosis of Hepatitis B virus (HBV), hepatitis C virus (HCV) (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening tests positive)â??.

l.Any other condition in view of PI/CO-I which might hamper patient safety.

Study & Design

• Study Type: Interventional
• Study Design: Not specified