Clinical trial NCT00346125: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma
Keywords: soft tissue sarcoma
Malignant fibrous histiocytoma
Liposarcoma
Fibrosarcoma
Leiomyosarcoma
Synovial sarcoma
Malignant peripheral nerve sheath tumor (MPNST)
Epithelioid sarcoma
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2006-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Disease-free survival
timeFrame: Baseline through Survival Event
Secondary outcomes:
measure: Correlate histologic response with FDG-PET/CT imaging
timeFrame: At end of each cycle
measure: Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations
timeFrame: Baseline Compared to 1 Cycle and Baseline to After Chemotherapy
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Edward Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.