PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
NCT ID: NCT00346125
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2006-04-10
2022-07-31
Brief Summary
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PURPOSE: This clinical trial is studying how well PET scan combined with CT scan predicts response in patients undergoing chemotherapy and surgery for soft tissue sarcoma.
Detailed Description
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Primary
* Determine whether measurements of fludeoxyglucose (FDG) positron emission tomography (PET)/CT imaging can accurately predict disease-free survival of patients with soft tissue sarcoma who are receiving neoadjuvant chemotherapy.
Secondary
* Correlate histological response to neoadjuvant chemotherapy for soft tissue sarcomas with FDG-PET/CT imaging findings.
Tertiary
* Determine the changes in FDG-PET/CT imaging over time as each course of chemotherapy is given.
OUTLINE: Patients receive 1 of 2 standard chemotherapy regimens:
* Preferred regimen: Patients receive pegylated doxorubicin HCl liposome IV on day 1, ifosfamide IV continuously on days 1-6, and pegfilgrastim subcutaneously (SC) on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
* Alternative regimen: Patients receive doxorubicin hydrochloride IV continuously on days 1-7. Patients also receive ifosfamide and pegfilgrastim as in the preferred regimen. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
All patients undergo a fludeoxyglucose positron emission tomography/CT scan at baseline, after course 1, and after completion of chemotherapy. Patients undergo surgery within 4-6 weeks after completion of chemotherapy.
After completion of study treatment and surgery, patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Preferred Standard Regimen
Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
pegfilgrastim
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
ifosfamide
9 g/m\^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m\^2 by continuous IV infusion over 7 days beginning on day 1
pegylated liposomal doxorubicin hydrochloride
45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
conventional surgery
The surgical procedure will be decided by the treating physician and independent of study participation
fludeoxyglucose F 18
FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.
Alternative Treatment Regimen
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
pegfilgrastim
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
doxorubicin hydrochloride
65 mg/m\^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
ifosfamide
9 g/m\^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m\^2 by continuous IV infusion over 7 days beginning on day 1
conventional surgery
The surgical procedure will be decided by the treating physician and independent of study participation
fludeoxyglucose F 18
FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.
Interventions
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pegfilgrastim
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
doxorubicin hydrochloride
65 mg/m\^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
ifosfamide
9 g/m\^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m\^2 by continuous IV infusion over 7 days beginning on day 1
pegylated liposomal doxorubicin hydrochloride
45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
conventional surgery
The surgical procedure will be decided by the treating physician and independent of study participation
fludeoxyglucose F 18
FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* malignant fibrous histiocytoma,
* liposarcoma,
* fibrosarcoma,
* leiomyosarcoma,
* synovial carcinoma,
* malignant peripheral nerve sheath tumor (MPNST),
* epithelioid sarcoma, and
* sarcomas-not otherwise specified.
NOTE: Ewings sarcoma, primitive neuroectodermal tumor, extraskeletal, osteosarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, rhabdomyosarcoma, carcinosarcoma, Kaposi's sarcoma, angiosarcoma, and mesothelioma patients are ineligible for this study.
* Measurable disease using traditional cross section measurements with the primary site's largest diameter \> 5 centimeters by positron emission tomography/computated tomography (PET/CT), CT or magnetic resonance imaging (MRI) scan. Patients with either localized (primary or locally recurrent) or metastatic disease at presentation are eligible for study if they are to receive neoadjuvant treatment prior to excision of the primary (stage IIC, III, IVA, IVB.)
* Age ≥ 16 years, Karnofsky ≥ 70%
* Adequate organ function for receiving chemotherapy as determined by the treating physician.
* Women of childbearing potential and sexually active males are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study.
Exclusion Criteria
* Females known to be pregnant or breast-feeding are excluded because PET/CT scan in pregnant women is not FDA approved.
* Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. Patients with PET-CT as an indicator of disease survival in soft tissue sarcoma untreated or symptomatic CNS metastases or uncontrolled diabetes will not be eligible.
Patient must give written informed consent indicating the investigational nature of the study and its potential risks.
16 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Edward Cheng, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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O'Donnell PW, Manivel JC, Cheng EY, Clohisy DR. Chemotherapy influences the pseudocapsule composition in soft tissue sarcomas. Clin Orthop Relat Res. 2014 Mar;472(3):849-55. doi: 10.1007/s11999-013-3022-7.
Other Identifiers
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UMN-0512M78446
Identifier Type: OTHER
Identifier Source: secondary_id
2005LS080
Identifier Type: -
Identifier Source: org_study_id