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PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma

NCT00346125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-12-15

No results posted yet for this study

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.

Conditions

  • Sarcoma

Interventions

BIOLOGICAL

pegfilgrastim

will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion

DRUG

doxorubicin hydrochloride

65 mg/m\^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1

DRUG

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

DRUG

pegylated liposomal doxorubicin hydrochloride

45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.

PROCEDURE

conventional surgery

The surgical procedure will be decided by the treating physician and independent of study participation

RADIATION

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.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Edward Cheng, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-10
Primary Completion
2013-07-01
Completion
2022-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00346125 on ClinicalTrials.gov