AzTrials
AzTrials

Colorectal CancerPhase 2NCT00023751

Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer

A Phase 2 study testing fluorouracil, leucovorin calcium and conventional surgery in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 180 sites in 3 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: 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 surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
fluorouracil, leucovorin calcium and conventional surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
180 sitesin 3 countries
Study dates
Jul 2001to Apr 2004
Phase
Phase 2
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 adenocarcinoma of the rectum
  • T1 or T2 by physical and endoscopic exams
  • No T3 lesions by clinical or radiological exam
  • Villous adenomas or in situ carcinoma allowed without histologicalconfirmation if clinical appearance of cancer
  • No multi-focal disease within the rectum at time of initial diagnosis
  • No non-adenocarcinomatous rectal cancer or anal cancer
  • Less than 4 cm at greatest diameter
  • Less than 40% of rectal wall circumference involved
  • Proximal margin no greater than 8 cm from dentate line
  • No tumor fixation to the perirectal tissues regardless of size
  • No malignant regional lymph node or distant metastases by clinical exam orradiographical imaging
  • No palpable perirectal lymph nodes or nodes larger than 1 cm
  • No evidence of malignant perirectal lymph nodes by endorectal ultrasound orendorectal MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • CTC 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times normal

Renal:

  • Creatinine less than 1.8 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior or concurrent malignancy within the past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • No prior surgery for rectal cancer including prior attempts at transanal or transcoccygeal surgical excision with unclear or positive margins
  • Prior incision or operative biopsy or colonoscopic removal allowed

Trial locations and contacts

180 sites in 3 countries.

180 sites in 3 countries

United States178 sites

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Ann Arbor

    Ann Arbor, Michigan, 48105

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0912

  • Northeast Alabama Regional Medical Center

    Anniston, Alabama, 36207

  • Veterans Affairs Medical Center - Asheville

    Asheville, North Carolina, 28805

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Baltimore

    Baltimore, Maryland, 21201

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Veterans Affairs Medical Center - Biloxi

    Biloxi, Mississippi, 39531-2410

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611-W227

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Barrett Cancer Center

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • NorthEast Oncology Associates

    Concord, North Carolina, 28025

  • Veterans Affairs Medical Center - Dallas

    Dallas, Texas, 75216

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Elmhurst Hospital Center

    Elmhurst, New York, 11373

  • Veterans Affairs Medical Center - Fargo

    Fargo, North Dakota, 58102

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28302-2000

  • Dwight David Eisenhower Army Medical Center

    Fort Gordon, Georgia, 30905-5650

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • Fort Wayne Medical Oncology and Hematology, Incorporated

    Fort Wayne, Indiana, 46885-5099

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • Memorial Regional Hospital Comprehensive Cancer Center

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813-2424

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4095

  • Veterans Affairs Medical Center - Houston

    Houston, Texas, 77030

  • St. Mary's Medical Center

    Huntington, West Virginia, 25701

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • Queens Cancer Center of Queens Hospital

    Jamaica, New York, 11432

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7353

  • Veterans Affairs Medical Center - Kansas City

    Kansas City, Missouri, 64128

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • Lenoir Memorial Hospital Cancer Center

    Kinston, North Carolina, 28503-1678

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Veterans Affairs Medical Center - Las Vegas

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock (McClellan)

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Veterans Affairs Medical Center - West Los Angeles

    Los Angeles, California, 90073

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Baptist Hospital East - Louisville

    Louisville, Kentucky, 40207

  • Texas Tech University Health Science Center

    Lubbock, Texas, 79415

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • University of Tennessee Cancer Institute

    Memphis, Tennessee, 38103

  • Danville Radiation Therapy Center

    Memphis, Tennessee, 38104

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Virginia Oncology Associates - Norfolk

    Norfolk, Virginia, 23502

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Veterans Affairs Medical Center - Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • CCOP - Greater Phoenix

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona, 85012

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Oregon Cancer Institute

    Portland, Oregon, 97201-3098

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Lifespan: The Miriam Hospital

    Providence, Rhode Island, 02906

  • Ministry Medical Group - Northern Region

    Rhinelander, Wisconsin, 54501

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • West Suburban Center for Cancer Care

    River Forest, Illinois, 60305

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Lakeland Medical Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112-5550

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71130

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Providence Hospital - Southfield

    Southfield, Michigan, 48075-9975

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13217

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Veterans Affairs Medical Center - Washington, DC

    Washington D.C., District of Columbia, 20422

  • Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center

    West Palm Beach, Florida, 33401

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28402-9025

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

Other trials in United States

Canada1 site

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Puerto Rico1 site

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, 00936-5067

Other trials in Puerto Rico

About this study

Official title: A Phase II Study of Local Excision Alone or Local Excision Plus Adjuvant Chemoradiation Therapy for Small Distal Rectal Cancers

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 surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer.

PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.

Read the detailed description

OBJECTIVES:

  • Determine the overall, disease-free, and colostomy-free survival rates in patients with stage I rectal cancer treated with local excision with or without adjuvant chemotherapy and radiotherapy.
  • Determine the local, regional, and distant recurrence rates in patients treated with these regimens.
  • Determine whether loco-regional recurrences after local excision can be successfully salvaged with radical surgery with or without adjuvant therapy for permanent cure in patients treated with these regimens.
  • Determine whether the analysis of certain histological and molecular markers can help determine prognosis in patients treated with these regimens.
  • Determine the anorectal, urinary, and sexual function effects in patients treated with these regimens.
  • Determine the non-functional treatment morbidity and mortality exclusive of anorectal, urinary, and sexual function effects in patients treated with these regimens.
  • Determine the overall survival of patients with pathology exclusions undergoing local excision.
  • Determine the efficacy of the current standard in detecting recurrence during follow-up, including office visits, blood tests, and proctoscopy in patients treated with these regimens.

OUTLINE: This is a multicenter study.

All patients undergo full thickness disc excision. Patients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy.

Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses.

Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

Being tested
fluorouracil, leucovorin calcium, conventional surgery, radiation therapy
Keywords
stage I rectal cancer, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

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

Study groups in NCT00023751
Study groupRoleWhat they receive
surgery + leucovorin + fluorouracil + radiationExperimentalPatients with T3 disease or positive surgical margins after surgery are removed from study. Patients with T1 disease and negative surgical margins after surgery are observed. Patients with T2 disease and negative surgical margins after surgery receive adjuvant therapy. Beginning 42 days after surgery, T2 patients receive leucovorin calcium (CF) IV over 2 hours with fluorouracil (5-FU) IV bolus 1 hour into the infusion once weekly for 6 weeks. Beginning 2 weeks after the completion of chemotherapy, patients receive chemoradiotherapy comprising radiotherapy once daily 5 times a week for 5 weeks and 5-FU IV continuously while receiving radiotherapy. Beginning 2 weeks after the completion of chemoradiotherapy, patients again receive CF IV over 2 hours with 5-FU IV bolus 1 hour into the infusion once weekly for 6 weeks. Chemotherapy repeats after 2 weeks rest for a total of 2 courses. Patients are followed every 3 months for 2 years and then every 6 months for 5 years.
Receives: Drug: fluorouracil; Drug: leucovorin calcium; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

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

  1. disease-free survival

    Measured: Up to 5 years

Secondary outcomes (2)

  1. overall survival

    Measured: Up to 5 years

  2. colostomy-free survival

    Measured: Up to 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 posted27 Jan 2003 (estimated)
  2. Study startJul 2001
  3. Primary completionApr 2004
  4. Study completionApr 2004

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023751
Sponsor's protocol ID
CALGB-80002
Other IDs
U10CA031946, CLB-80002, SWOG-C80002, CDR0000068858
Status last verified
Jul 2016
First submitted
13 Sep 2001
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fluorouracil, leucovorin calcium and conventional surgery in people with Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 180 sites in 3 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 180 sites in United States, Canada, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

disease-free survival (time frame: Up to 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 NCT00023751.

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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