Transcatheter Intra-arterial Limb Infusion of Cisplatin for Extremity Osteosarcoma

NCT03909776 | Completed

• 1 other identifier: CBTRA-03/PKUPH-sarcoma 06
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Although there seems to be no benefit from improving the histologic response rate or long-term survival of intra-arterial infusion of cisplatin for localized osteosarcoma of extremities with IOR/OS-3, IOR/OS-5, and COSS 86 protocols, such a treatment strategy is still believed to potentially increase the tumoricidal effect with an increase in higher local concentrations of the infused agents combined with longer tissue exposure time. Besides, the relationship of chemotherapy-induced necrosis and surgical margins is still the main concern for localized osteosarcoma patients to achieve long-term survival. The investigators intend to analyze the gain and loss from transcatheter intra-arterial limb infusion of cisplatin for extremity osteosarcoma in the past six years.

Conditions

Event-free Survival; Overall Survival; Local-recurrence Free Survival; Pathological Response

Keywords

osteosarcoma; Intra-arterial chemotherapy; survival; Tumor neovascularity; telangiectatic subtype; complications

Outcome Measures

Primary Outcomes (2)

• event-free survival, EFS

  We calculated EFS from the date of diagnosis to the last follow-up, local recurrence, distant metastasis, or death.

  5 years

• overall survival, OS

  We calculated OS from the date of diagnosis to the last follow-up or death.

  5 years

Secondary Outcomes (2)

• pathological response

  2 years

• recurrence-free survival

  5 years

Study Arms (2)

IA group

ACTIVE COMPARATOR

Cisplatin was given via insertion of a catheter percutaneously by using the Seldinger technique through the brachial or femoral artery under anesthesia and usually at 120 mg/m2 as a 3-h/6-h continuous infusion.

Drug: Cisplatin

IV group

SHAM COMPARATOR

Cisplatin was given at 100-120 mg/m2 as 6-h infusions.

Drug: Cisplatin

Interventions

Cisplatin DRUG

Cisplatin was administered intravenously or intraarterially after adequate IV hydration. For IA infusion, cisplatin was given via insertion of a catheter percutaneously by using the Seldinger technique through the brachial or femoral artery under anesthesia and usually at 120 mg/m2 as a 3-h/6-h continuous infusion; while for IV administration, it was given at 100-120 mg/m2 as 6-h infusions.

IA group; IV group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• histological diagnosis of high-grade osteosarcoma
• located at extremities
• following the PKUPH-OS protocol
• accept to recieve IA or IV infusion of cisplatin

You may not qualify if:

• lost to follow-up
• did not recieve definitve surgery in Musculoskeletal Tumor Center of Peking University People's Hospital
• quiting to recieve chemotherapy

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Xie L, Xu J, Dong S, Gao J, Tang X, Yan T, Yang R, Guo W. Gain and loss from transcatheter intra-arterial limb infusion of cisplatin for extremity osteosarcoma: a retrospective study of 99 cases in the past six years. Cancer Manag Res. 2019 Jul 30;11:7183-7195. doi: 10.2147/CMAR.S214604. eCollection 2019.

  PMID: 31447583 RESULT

MeSH Terms

Conditions

Osteosarcoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wei Guo, M.D. and Ph.D.

  Musculoskeletal Tumor Center of Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: January 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 8, 2019
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)