Status:
UNKNOWN
Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Osteosarcoma
Eligibility:
All Genders
10-60 years
Phase:
PHASE2
Brief Summary
Osteosarcoma is the most common primary highly malignant bone tumor in children and young people. Incidence rates are bimodal, with the first peak occurring in adolescence and the second peak in patie...
Detailed Description
This project intends to conduct a multicenter, randomized, double-blind, parallel-controlled clinical trial of ganoderma spore powder and doxorubicin combined with cisplatin chemotherapy in the treatm...
Eligibility Criteria
Inclusion
- \- Signed informed consent form
- Clinical diagnosis of osteosarcoma
- Must be able to swallow tablets
- after surgical resection
Exclusion
- \- Symptomatic central nervous system metastases and/or carcinomatous meningitis Known HIV or active hepatitis B/C infection
- Active infection requiring systemic treatment
- Clinically significant cardiac arrhythmias
- Class III or IV Congestive Heart Failure as defined by the New York Heart
- Association functional classification system \< 6 months prior to screening
- A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Any condition for which participation would not be in the best interest of the participant
- Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
- Patients participating in another clinical investigation at the time of signature of the informed consent
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04319874
Start Date
September 15 2020
End Date
September 15 2025
Last Update
March 30 2020
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