SarcomaNCT00346125
PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
A study testing pegfilgrastim, doxorubicin hydrochloride and ifosfamide in people with Sarcoma, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- pegfilgrastim, doxorubicin hydrochloride and ifosfamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2006to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed, high grade, soft tissue sarcoma including
- malignant fibrous histiocytoma,
- liposarcoma,
- fibrosarcoma,
- leiomyosarcoma,
- synovial carcinoma,
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- pegfilgrastim, doxorubicin hydrochloride, ifosfamide, pegylated liposomal doxorubicin hydrochloride, conventional surgery
- Keywords
- soft tissue sarcoma, Malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Leiomyosarcoma, Synovial sarcoma, Malignant peripheral nerve sheath tumor (MPNST), Epithelioid sarcoma
- Medical subject headings
- Sarcoma, Histiocytoma, Malignant Fibrous, Liposarcoma, Fibrosarcoma, Leiomyosarcoma, Sarcoma, Synovial, Neurofibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegfilgrastimBiological
Also called Neulasta(R)
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
Also called Doxorubicin, Adriamycin
65 mg/m^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
ifosfamideDrug
Also called Mitoxana, Ifex
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 hydrochlorideDrug
Also called doxorubicin-hydrochloride-liposome
45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
conventional surgeryProcedure or surgery
The surgical procedure will be decided by the treating physician and independent of study participation
fludeoxyglucose F 18Radiation
Also called FDG
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.
| Study group | Role | What they receive |
|---|---|---|
| Preferred Standard Regimen | Active comparator | 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 Receives: Biological: pegfilgrastim; Drug: ifosfamide; Drug: pegylated liposomal doxorubicin hydrochloride; Procedure: conventional surgery; Radiation: fludeoxyglucose F 18 |
| Alternative Treatment Regimen | Active comparator | Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total Receives: Biological: pegfilgrastim; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Procedure: conventional surgery; Radiation: fludeoxyglucose F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through Survival Event
Secondary outcomes (2)
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
Measured: At end of each cycle
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.
Measured: Baseline Compared to 1 Cycle and Baseline to After Chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study start10 Apr 2006
- Primary completion1 Jul 2013
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Cheng, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346125
- Sponsor's protocol ID
- 2005LS080
- Other IDs
- UMN-0512M78446
- Status last verified
- Dec 2022
- First submitted
- 28 Jun 2006
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23640206
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00346125
- Acronym / sponsor ID
- 2005LS080
- Conditions
- Sarcoma
- Keywords
- soft tissue sarcoma, Malignant fibrous histiocytoma, Liposarcoma, Fibrosarcoma, Leiomyosarcoma, Synovial sarcoma, Malignant peripheral nerve sheath tumor (MPNST), Epithelioid sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 10 Apr 2006 (actual)
- Primary completion
- 1 Jul 2013 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preferred Standard Regimen | Active comparator | Biological: pegfilgrastim, Drug: ifosfamide, Drug: pegylated liposomal doxorubicin hydrochloride, Procedure: conventional surgery, Radiation: fludeoxyglucose F 18Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total |
| Alternative Treatment Regimen | Active comparator | Biological: pegfilgrastim, Drug: doxorubicin hydrochloride, Drug: ifosfamide, Procedure: conventional surgery, Radiation: fludeoxyglucose F 18Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histologically confirmed, high grade, soft tissue sarcoma including
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegfilgrastimAlso: Neulasta(R)will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion | Biological | Alternative Treatment Regimen, Preferred Standard Regimen |
| doxorubicin hydrochlorideAlso: Doxorubicin, Adriamycin65 mg/m^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1 | Drug | Alternative Treatment Regimen |
| ifosfamideAlso: Mitoxana, Ifex9 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 | Drug | Alternative Treatment Regimen, Preferred Standard Regimen |
| pegylated liposomal doxorubicin hydrochlorideAlso: doxorubicin-hydrochloride-liposome45 mg/m2 intravenous (IV) Day 1, repeat every 28 days. | Drug | Preferred Standard Regimen |
| conventional surgeryThe surgical procedure will be decided by the treating physician and independent of study participation | Procedure or surgery | Alternative Treatment Regimen, Preferred Standard Regimen |
| fludeoxyglucose F 18Also: FDGFDG 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. | Radiation | Alternative Treatment Regimen, Preferred Standard Regimen |
Primary outcome
Disease-free survival
Time frame: Baseline through Survival Event
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.
2 secondary outcomes
Correlate histologic response with FDG-PET/CT imaging
Time frame: At end of each cycle
Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations
Time frame: Baseline Compared to 1 Cycle and Baseline to After Chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 23640206O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Cheng, MD principal investigator
Masonic Cancer Center, University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pegfilgrastim, doxorubicin hydrochloride and ifosfamide in people with Sarcoma, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: Baseline through Survival Event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.