Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT01848457
Eligibility Criteria:
Inclusion Criteria:
* \<30 years of age
* histological diagnosis of high-grade osteosarcoma
* Extremity or central axis (including craniofacial) primary tumor; localized or metastatic
* No prior chemotherapy or radiation therapy for osteosarcoma. Subjects who develop osteosarcoma as a second cancer are eligible if they have not previously received cisplatin, doxorubicin or other anthracyclines, or MTX
* Serum creatinine at or below the upper limit of normal (ULN) for age and gender
* Shortening fraction on echocardiogram \>28%
* Hearing level threshold ≤25 dB at all frequencies in both ears to be evaluable for evaluation of pantoprazole's effect on cisplatin ototoxicity. Patients with hearing loss can be enrolled but will not be evaluable for ototoxicity objective.
* Absolute neutrophil count \>1,000/microliter(mcL) and platelet count \>100,000/mcL
Exclusion Criteria:
* Receiving H2 antagonists (cimetidine, ranitidine, famotidine, nizatidine) or proton pump inhibitors (lansoprazole, omeprazole, pantoprazole, esomeprazole, rabeprazole, dexlansoprazole) AND unable to hold the drug for 24 h prior to and 24 h after each cisplatin course on cycles 1-4.
* Pregnant or breastfeeding
* Unable to cooperate with research procedures
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Years
Study:
NCT01848457
Study Brief:
Protocol Section:
NCT01848457