Clinical trial · Interventional
PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Preferred Standard Regimen
- 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
- interventionNames
- Biological: pegfilgrastim
- Drug: ifosfamide
- Drug: pegylated liposomal doxorubicin hydrochloride
- Procedure: conventional surgery
- Radiation: fludeoxyglucose F 18
- type
- ACTIVE_COMPARATOR
- label
- Alternative Treatment Regimen
- description
- Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
- interventionNames
- Biological: pegfilgrastim
- Drug: doxorubicin hydrochloride
- Drug: ifosfamide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDO'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. PMID 23640206