Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma

Sponsor
Oslo University Hospital
Study ID
NCT04776525
Phase
PHASE2
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ifosfamide — DRUG
    3 g/m2 each day for three days
  • Doxorubicin — DRUG
    80 mg/m2 over four hours day 1

Study Details

Nearly half of patients with high-grade, localized soft tissue sarcoma (STS) of extremities and trunk wall develop disease recurrence after local therapy. Adjuvant chemotherapy with ifosfamide and doxorubicin may improve long-term disease-free survival, but the benefit of adjuvant treatment is limited and predictive factors for treatment response are lacking. The aim of this study is to explore sequential treatment with ifosfamide and doxorubicin in a neoadjuvant setting and to investigate biomarkers predictive of treatment response.

Key Dates

First listed
Mar 1, 2021
Start date
Apr 27, 2021
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2036

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sequential ifosfamide and doxorubicin
    Four cycles ifosfamide 9 g/m2 and four cycles doxorubicin 80 mg/m2. Each cycle has a duration of 14 days.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 16 weeks ]

Central Contacts

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