Back to resultsPET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
Primary Purpose
Sarcoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pegfilgrastim
doxorubicin hydrochloride
ifosfamide
pegylated liposomal doxorubicin hydrochloride
conventional surgery
fludeoxyglucose F 18
Sponsored by
About this trial
This is an interventional diagnostic trial for Sarcoma focused on measuring soft tissue sarcoma, Malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Leiomyosarcoma, Synovial sarcoma, Malignant peripheral nerve sheath tumor (MPNST), Epithelioid sarcoma
Eligibility Criteria
Inclusion Criteria: Patients must have histologically confirmed, high grade, soft tissue sarcoma including 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: Previous treatment with chemotherapy or radiation therapy 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.
Sites / Locations
- Sinai Hospital of Baltimore
- Masonic Cancer Center at University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Preferred Standard Regimen
Alternative Treatment Regimen
Arm Description
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
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Outcomes
Primary Outcome Measures
Disease-free survival
Compare changes in baseline and follow-up fludeoxyglucose (FDG) positron emission tomography (PET)/CT imaging with disease-free survival by peak SUV and max SUV calculations. Changes in baseline and follow-up PET/CT, based on max SUV calculations, will be compared with disease free survival. Disease free survival will be measured in months from the time of study enrollment until the time that disease recurrence/relapse/progression is recorded.
Secondary Outcome Measures
Correlate histologic response with FDG-PET/CT imaging
The overall histologic response will be defined as:
% histologic response = 100 - % viable tumor in the central slice as assessed histologically It should be noted that the % histologic response is different from % tumor necrosis as it includes an assessment of the % tumor necrosis along with the degenerative changes
Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations
Changes in PET/CT from baseline will be compared to PET/CT done after one cycle and after completion of chemotherapy treatment before surgical excision using max SUV calculations.
Full Information
NCT ID
NCT00346125
First Posted
June 28, 2006
Last Updated
December 13, 2022
Sponsor
Masonic Cancer Center, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00346125
Brief Title
PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
Official Title
An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2006 (Actual)
Primary Completion Date
July 1, 2013 (Actual)
Study Completion Date
July 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) scan and computated tomography (CT) scan, may help doctors predict a patient's response to treatment and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
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
OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
soft tissue sarcoma, Malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Leiomyosarcoma, Synovial sarcoma, Malignant peripheral nerve sheath tumor (MPNST), Epithelioid sarcoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preferred Standard Regimen
Arm Type
Active Comparator
Arm Description
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
Arm Title
Alternative Treatment Regimen
Arm Type
Active Comparator
Arm Description
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Other Intervention Name(s)
Neulasta(R)
Intervention Description
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Other Intervention Name(s)
Doxorubicin, Adriamycin
Intervention Description
65 mg/m^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Other Intervention Name(s)
Mitoxana, Ifex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride
Other Intervention Name(s)
doxorubicin-hydrochloride-liposome
Intervention Description
45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
The surgical procedure will be decided by the treating physician and independent of study participation
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Other Intervention Name(s)
FDG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
Compare changes in baseline and follow-up fludeoxyglucose (FDG) positron emission tomography (PET)/CT imaging with disease-free survival by peak SUV and max SUV calculations. Changes in baseline and follow-up PET/CT, based on max SUV calculations, will be compared with disease free survival. Disease free survival will be measured in months from the time of study enrollment until the time that disease recurrence/relapse/progression is recorded.
Time Frame
Baseline through Survival Event
Secondary Outcome Measure Information:
Title
Correlate histologic response with FDG-PET/CT imaging
Description
The overall histologic response will be defined as:
% histologic response = 100 - % viable tumor in the central slice as assessed histologically It should be noted that the % histologic response is different from % tumor necrosis as it includes an assessment of the % tumor necrosis along with the degenerative changes
Time Frame
At end of each cycle
Title
Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations
Description
Changes in PET/CT from baseline will be compared to PET/CT done after one cycle and after completion of chemotherapy treatment before surgical excision using max SUV calculations.
Time Frame
Baseline Compared to 1 Cycle and Baseline to After Chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically confirmed, high grade, soft tissue sarcoma including
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:
Previous treatment with chemotherapy or radiation therapy
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Cheng, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23640206
Citation
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.
Results Reference
derived
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PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
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