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SarcomaPhase 3NCT00091351

Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis

A Phase 3 study testing conventional surgery and radiation therapy in people with Sarcoma, run by Alliance for Clinical Trials in Oncology at 59 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
conventional surgery and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
59 sitesin 2 countries
Study dates
Aug 2004to Feb 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary soft tissue sarcoma of the retroperitoneum or pelvis (e.g., iliac fossa)
  • The following histologies are eligible:
  • Alveolar soft part sarcoma
  • Anaplastic sarcoma
  • Angiosarcoma
  • Atypical lipomatous tumor (low-grade liposarcoma)
  • Clear cell sarcoma
  • Epithelioid sarcoma
  • Fibrosarcoma
  • Leiomyosarcoma
  • Liposarcoma (all subtypes)
  • Malignant fibrous histiocytoma
  • Malignant peripheral nerve sheath tumor
  • Myxofibrosarcoma
  • Neurofibrosarcoma
  • Spindle cell sarcoma
  • Synovial sarcoma
  • Unclassified sarcoma
  • The following histologies are not eligible:
  • Rhabdomyosarcoma
  • Extraosseous Ewing's sarcoma
  • Primitive neuroectodermal tumor
  • Osteosarcoma
  • Chondrosarcoma
  • Aggressive fibromatosis (desmoid tumor)
  • Gastrointestinal stromal tumor
  • Sarcomatoid carcinoma
  • Hemangiopericytoma
  • Retroperitoneal sarcomas located predominantly in the retroperitoneum extending across the inguinal ligament into the abdominal wall are allowed provided that ≥ 90% of the tumor volume is located within the retroperitoneal space
  • No bowel obstruction OR history of previous bowel obstruction attributed to retroperitoneal tumor
  • Primary non-visceral retroperitoneal masses consistent with sarcoma allowed provided diagnoses of carcinoma, melanoma, and lymphoma are excluded by immunohistochemistry
  • Measurable gross disease by abdominopelvic CT scan (with IV and oral contrast) or MRI (with IV contrast)
  • Patients must have undergone radiotherapy consultation within the past 30 days to confirm the feasibility of preoperative external-beam radiotherapy
  • Patients must have undergone surgical consultation within the past 30 days to confirm and document the feasibility of macroscopically complete resection
  • No prior macroscopically incomplete (R2) resection (i.e., partial debulking or subtotal tumor resection with gross residual disease)
  • No pelvic sarcoma extending through the sciatic notch
  • No clinical or radiographic evidence of probable metastatic disease
  • Equivocal pulmonary or liver lesion allowed provided the likelihood of metastatic disease is small
  • No sarcoma arising from bone or any retroperitoneal viscus (except the kidney)
  • No sarcoma extending across the diaphragm into the thorax
  • No recurrent retroperitoneal tumor
  • No multifocal disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1 OR
  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 2,500/mm^3
  • Platelet count ≥ 80,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN
  • Albumin normal* NOTE: *Higher levels allowed

Renal

  • Creatinine normal
  • BUN normal
  • Functional kidney confirmed by intravenous pyelogram and/or differential renal isotope scan

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No other malignancy within the past 5 years (except effectively treated basal cell or squamous cell skin cancer) unless patient was curatively treated AND is at low risk for recurrence

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No concurrent chemotherapy for primary tumor

Radiotherapy

  • No prior abdominal or pelvic irradiation
  • No concurrent intraoperative or postoperative radiotherapy for primary tumor

Surgery

  • See Disease Characteristics

Trial locations and contacts

59 sites in 2 countries.

59 sites in 2 countries

United States55 sites

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • American Fork Hospital

    American Fork, Utah, 84003

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • U.T. Cancer Institute at University of Tennessee Medical Center

    Knoxville, Tennessee, 37920-6999

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

    Olympia Fields, Illinois, 60461

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase-Temple Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403-3089

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

Canada4 sites

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS)

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy.

PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.

Read the detailed description

OBJECTIVES:

Primary

  • Compare progression-free survival of patients with primary soft tissue sarcoma of the retroperitoneum or pelvis treated with surgery with vs without preoperative radiotherapy.

Secondary

  • Compare the toxicity and complications associated with these regimens in these patients.
  • Compare the rate of microscopically complete surgical resection in patients treated with these regimens.
  • Compare the overall survival rate of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor grade (low [G1] vs intermediate [G2] vs high [G3/4]), tumor size (< 15 cm vs ≥ 15 cm), and tumor histology (liposarcoma vs non-liposarcoma). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo surgery.
  • Arm II: Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 4.5 years.

Conditions
Sarcoma
Being tested
conventional surgery, radiation therapy
Keywords
adult alveolar soft-part sarcoma, adult angiosarcoma, adult epithelioid sarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, adult malignant fibrous histiocytoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma
Medical subject headings
Sarcoma, Sarcoma, Alveolar Soft Part, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Neurofibrosarcoma, Sarcoma, Synovial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00091351
Study groupRoleWhat they receive
surgeryExperimentalPatients undergo surgery. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
Receives: Procedure: conventional surgery
radiation + surgeryExperimentalPatients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.
Receives: Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival at 5 years

    Measured: at 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2004 (estimated)
  2. Study startAug 2004
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091351
Sponsor's protocol ID
ACOSOG-Z9031
Other IDs
ACOSOG-Z9031, CDR0000387803
Status last verified
Jul 2016
First submitted
7 Sep 2004
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing conventional surgery and radiation therapy in people with Sarcoma, run by Alliance for Clinical Trials in Oncology at 59 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival at 5 years (time frame: at 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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