NCT00004109

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus external-beam radiation therapy in treating patients who have soft tissue sarcoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

March 15, 2004

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

3.5 years

First QC Date

December 10, 1999

Last Update Submit

August 1, 2012

Conditions

Sarcoma

Keywords

stage III adult soft tissue sarcomarecurrent adult soft tissue sarcomaDoxorubicinExternal-Beam RTXRTcancerPREOPERATIVE CONCURRENT CHEMORADIATIONEXTREMITY SOFT TISSUE SARCOMASTRUNK SOFT TISSUE SARCOMASConcurrent ChemoradiationSurgical ResectionLocalized Extremity Soft Tissue SarcomasBody Wall Soft Tissue Sarcomas

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    MTD of doxorubicin intravenous (IV) based on presence of dose limiting toxicities. For dose-finding purposes, a dose-limiting toxicity (DLT) was defined as grade 3 or greater treatment-related cutaneous toxicity

    Continousouly during 5 weeks treatment

Study Arms (1)

Doxorubicin + External-Beam RT

EXPERIMENTAL
Drug: Doxorubicin HydrochlorideRadiation: Radiation Therapy (RT)

Interventions

Doxorubicin HydrochlorideDRUG

Doxorubicin dose will not exceed 20 mg/m2 per week IV over 4 days every week for 5 weeks

Also known as: doxorubicin
Doxorubicin + External-Beam RT
Radiation Therapy (RT)RADIATION

External-beam radiotherapy at a dose of 50 Gy (2.0 x 25 fractions, weeks 1-5).

Also known as: RT, Radialtherapy
Doxorubicin + External-Beam RT

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have cytologic or histologic proof of large (\>5 mc), Grade III, resectable soft tissue sarcoma of the extremity or trunk (AJCC Stage IIIB). Patients with The American Joint Committee on Cancer (AJCC) Stage IIB tumors (Grade II) greater than 8 cms will also be eligible.
  • Patients may have measurable or non-measurable disease (C/P pre-referral excision).
  • Patients may have had prior doxorubicin (up to a total doxorubicin dose of 450 mg/m2).
  • Patients may have a prior history of malignancy (at the discretion of the Principal Investigator).
  • Patients must have Karnofsky Point Scale (P.S.)\> of \>70 or Xubrod P.S. of 0 or 1.
  • Patients must have: Absolute neutrophil count (ANC) \> 1,500 cells/mm; platelet count \> 100,000 platelets/ml; serum creatinine \<1.8 mg/dl, aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \< 3 times normal, total bilirubin \< 1.5mg/dl; for patients with cumulative Adriamycin 450 mg/M2, EF \>50%.
  • Women of childbearing potential must not be pregnant or breast feeding and must practice adequate contraception.

You may not qualify if:

  • Patients must not have had prior radiation therapy (XRT) in the area of the primary tumor, and the anticipated XRT field must not include the perineum, scrotum, or vaginal introitus.
  • Patients with uncontrolled coexisting medical conditions are excluded.
  • Patient must not be pregnant or brest feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

SarcomaNeoplasms

Interventions

DoxorubicinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTherapeutics

Study Officials

  • Peter W. Pisters, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

March 15, 2004

Study Start

March 1, 1998

Primary Completion

September 1, 2001

Study Completion

April 1, 2011

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(1)