NCT00004123

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 1997

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

July 1, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

4 years

First QC Date

December 10, 1999

Last Update Submit

July 27, 2012

Conditions

Sarcoma

Keywords

adult leiomyosarcomaadult liposarcomastage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage II adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Preoperative External Beam Radiotherapy, Doxorubicin + Intraoperative Radiotherapy

    The MTD is defined as the dose at which 30% of patients experience grade 3 or worse dose-limiting toxicity

    6 weeks

Study Arms (1)

RT + DOX + IORT

EXPERIMENTAL

Preoperative external beam radiotherapy (RT) combined with doxorubicin (DOX) and followed by intraoperative radiotherapy (IORT); dose-escalation study of external beam radiotherapy.

Drug: Doxorubicin hydrochloride (DOX)Procedure: Conventional surgeryRadiation: Intraoperative radiation therapy (IORT)Radiation: Radiation Therapy (RT)

Interventions

Doxorubicin hydrochloride (DOX)DRUG

Doxorubicin IV bolus followed immediately by IV over 4 days every week for 5 weeks concurrently with external beam radiotherapy 5 days a week for 4 weeks.

Also known as: Rubex, Adriamycin
RT + DOX + IORT
Conventional surgeryPROCEDURE

Surgical resection of primary tumor and all adjacent gross disease approximately 6 weeks after chemoradiotherapy

RT + DOX + IORT
Intraoperative radiation therapy (IORT)RADIATION

Intraoperative radiotherapy (IORT) to tumor bed if all gross disease has been resected and if area of maximal tumor adherence to retroperitoneum can be encompassed within a single IORT field (maximum 15 cm).

RT + DOX + IORT
Radiation Therapy (RT)RADIATION

5 days a week for 4 weeks

Also known as: RT, Radialtherapy
RT + DOX + IORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically proven resectable primary or recurrent soft tissue sarcoma of the retroperitoneum Greatest dimension of the 3-dimensional assessment of tumor size must be 5-35 cm Grade 2 or 3, including dedifferentiated liposarcoma and retroperitoneal recurrences of gastrointestinal leiomyosarcoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Zubrod 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Renal function normal Creatinine less than 1.6 mg/dL Gastrointestinal: Must maintain adequate oral nutrition (90-100% of estimated need for calories and protein) and be free of nausea and vomiting prior to radiotherapy (feeding tube allowed) Other: Prior malignancy allowed at the discretion of the protocol investigator No other serious uncontrolled medical condition Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior abdominal radiotherapy Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

SarcomaLeiomyosarcomaLiposarcoma

Interventions

DoxorubicinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Muscle TissueNeoplasms, Adipose Tissue

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 23, 2004

Study Start

July 1, 1997

Primary Completion

July 1, 2001

Study Completion

October 1, 2009

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)