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Cervical CancerPhase 3NCT00980954

Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy

A Phase 3 study testing carboplatin, cisplatin and paclitaxel in people with Cervical Cancer, run by Radiation Therapy Oncology Group at 125 sites in 4 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, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
carboplatin, cisplatin and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
125 sitesin 4 countries
Study dates
Sep 2009to 4 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
  • Positive pelvic nodes
  • Positive parametrium
  • Positive para-aortic nodes that have been completely resected and are positron emission tomography (PET)/computed tomography (CT) scan-negative
  • PET only required if positive para-aortic nodes during surgery
  • Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node metastasis (TNM) staging of T1-T2, N1, M0)
  • Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
  • Para-aortic and pelvic node sampling required
  • If the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required
  • A negative pre- or post-operative PET scan or PET-CT scan of the para-aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection
  • No gross residual disease
  • No neuroendocrine histology
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800/mm³
  • Platelets ≥ 100,000/mm³
  • White blood cell count (WBC) ≥ 4,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Serum creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) normal
  • Alkaline phosphatase normal
  • Known HIV positivity allowed provided cluster of differentiation 4 (CD4) count is ≥ 350/mm³ within the past 14 days
  • No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Transmural myocardial infarction within the past 6 months
  • Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
  • Coagulation defects
  • No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy for the current cervical cancer
  • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields

Trial locations and contacts

125 sites in 4 countries.

125 sites in 4 countries

United States119 sites

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • Grady Health System

    Atlanta, Georgia, 30303

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Medical Center

    Duarte, California, 91010

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Franciscan Saint Margaret Health-Hammond Campus

    Hammond, Indiana, 46320

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Memorial Healthcare System - Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • Franciscan Saint Francis Health-Indianapolis

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Cancer Center - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Kansas City Cancer Center-Lee's Summit

    Lee's Summit, Missouri, 64064

  • Elliot Hospital

    Manchester, New Hampshire, 03103

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Summa Health Center at Lake Medina

    Medina, Ohio, 44256

  • Jackson Memorial Hospital-Holtz Children's Hospital

    Miami, Florida, 33136

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545-1470

  • Providence Hospital

    Mobile, Alabama, 36608

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060

  • Intermountain Medical Center

    Murray, Utah, 84157

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • UMDNJ - New Jersey Medical School

    Newark, New Jersey, 07103

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • UHHS-Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • Florida Hospital

    Orlando, Florida, 32803

  • Kansas City Cancer Centers-Southwest

    Overland Park, Kansas, 66210

  • Arizona Center for Cancer Care-Peoria

    Peoria, Arizona, 85381

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Robinson Radiation Oncology

    Ravenna, Ohio, 44266

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

  • Mercy Cancer Center

    Sacramento, California, 95816

  • Mercy General Hospital Radiation Oncology Center

    Sacramento, California, 95819

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of California At San Diego

    San Diego, California, 92103

  • Ireland Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Saint Joseph's-Candler Health System

    Savannah, Georgia, 31405

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Sanford Cancer Center-Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Saint Helena Hospital

    St. Helena, California, 94574

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Montefiore Medical Center-Weiler Division

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

  • University of Toledo

    Toledo, Ohio, 43614

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

Other trials in United States

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam, Kyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 110-744

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Korea Cancer Center Hospital

    Seoul, 139-706

Other trials in South Korea

Canada1 site

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

Other trials in Canada

Hong Kong1 site

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan

Other trials in Hong Kong

About this study

Official title: Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.

Read the detailed description

OBJECTIVES:

Primary

  • To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy.

Secondary

  • To evaluate adverse events.
  • To evaluate overall survival.
  • To evaluate quality of life.
  • To evaluate chemotherapy-induced neuropathy.
  • To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy (IMRT) with respect to toxicity and local control.
  • To collect fixed tissue samples to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.
  • To collect blood samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to identify single nucleotide polymorphisms (SNPs) in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy.

OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs. yes), radiotherapy modality - [standard external beam radiotherapy (EBRT) vs. intensity-modulated radiotherapy (IMRT)], and radiotherapy dose (45 Gy vs. 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.

NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.

  • Arm II: Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed by the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group (FACT-GOG/NTX4), FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy.

Blood and tissue samples may be collected for gene expression analysis by immuno-histochemistry (IHC) and for biomarker and polymorphism studies.

After completion of study treatment, patients are followed up very 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions
Cervical Cancer
Being tested
carboplatin, cisplatin, paclitaxel, intensity-modulated radiation therapy, standard external beam radiation therapy
Keywords
cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • carboplatinDrug

    Intravenously

  • cisplatinDrug

    Intravenously

  • paclitaxelDrug

    Intravenously

  • intensity-modulated radiation therapyRadiation

    Also called IMRT

    Daily fractions

  • standard external beam radiation therapyRadiation

    Also called EBRT

    Daily fractions

  • Optional brachytherapy boostRadiation

    Low-dose rate (20-25 Gy single application) or high-dose rate (12-18 Gy 2-3 applications), dependent on external beam dose.

Study groups in NCT00980954
Study groupRoleWhat they receive
Arm I: Cisplatin/Radiation TherapyActive comparatorStandard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks as 45 Gy in 25 fractions or 50.4 Gy in 28 fractions (1.8 Gy/fraction). Concurrent cisplatin IV over one hour once weekly for 6 weeks as 40 mg/m^2, maximum dose 70 mg. A brachytherapy boost following radiation therapy is optional.
Receives: Drug: cisplatin; Radiation: intensity-modulated radiation therapy; Radiation: standard external beam radiation therapy; Radiation: Optional brachytherapy boost
Arm II: Cisplatin/Radiation Therapy + Carboplatin/PaclitaxelExperimentalChemoradiotherapy as in arm I, followed 4-6 weeks later by paclitaxel IV [135 mg/m2, with maximum body surface area (BSA) of 2.0 m^2 over 3 hours] and carboplatin IV [area under the curve (AUC) 5 over 30 minutes] on day 1 of 21-day cycle for 4 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Radiation: intensity-modulated radiation therapy; Radiation: standard external beam radiation therapy; Radiation: Optional brachytherapy boost

What is being measured

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

  1. Disease-free Survival (Percentage of Participants Alive Without Disease)

    Disease-free survival (DFS) is estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. DFS time is measured from the date of randomization to the date of first DFS failure (local, regional or distant metastases failure or death due to any cause) or last follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.

    Measured: From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.

Secondary outcomes (8)

  1. Overall Survival (Percentage of Participants Alive)

    Overall survival is estimated by the Kaplan-Meier method. The distribution of survival estimates between the two arms is compared using the log rank test. Survival time is measured from the date of randomization to the date of death from any cause or last known follow-up (censored). Analysis was to occur after disease or death was reported for 50 participants.

    Measured: From randomization to death or last follow-up. Maximum follow-up time at time of analysis was 12.8 years. The 2- and 4-year survival estimates are reported.

  2. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) at 12 Months

    The FACT-GOG/NTX4 measures patient-reported symptoms of chemotherapy-induced peripheral neuropathy in cancer patients. Possible scores range from 0 to 16 with higher scores indicating a better condition. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.

    Measured: Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)

  3. Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Diarrhea Subscore at 12 Months

    The diarrhea-specific subscore of the FACIT-D measures patient-reported diarrhea symptoms. Possible scores range from 0 to 44 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.

    Measured: Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)

  4. Functional Assessment of Cancer Therapy - Cervix (FACT-Cx) Cervical Cancer Subscore at 12 Months

    The cervical cancer subscore of the FACT-Cx measures patient-reported symptoms and problems related to cervical cancer. Possible scores range from 0 to 60 with higher scores indicating a better quality of life. Analysis of covariance, using the baseline score as a covariate, will be used to determine if there is a difference between the treatment arms.

    Measured: Baseline and 12 months after the completion of concurrent chemoradiation (6 weeks)

  5. Number of Participants by Highest Grade Adverse Event Reported

    Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: From randomization to the date of last known follow-up. Maximum follow-up time was 12.8 years.

  6. Associations Between Tumor Molecular Signatures, From Fixed Tissue, and Outcomes Such as Adverse Events, Disease Free Survival and Overall Survival

    Measured: From randomization to last follow-up

  7. Associations Between Secreted Factors From Serum and Plasma With Adverse Events or Outcome

    Measured: From randomization to last follow-up.

  8. Associations Between Single Nucleotide Polymorphisms (SNPs) in Genes From Buffy Coat and a Genetic Predisposition to Tumor Formation Itself or a Response to Cytotoxic Therapy

    Measured: From randomization to last follow-up.

Timeline

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

  1. First posted21 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completion14 Dec 2023
  4. Study completion4 Sep 2025

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
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00980954
Sponsor's protocol ID
RTOG-0724
Other IDs
CDR0000654709, NCI-2011-01973, RTOG 0724/GOG-0724
Status last verified
Sep 2025
First submitted
18 Sep 2009
Last updated
31 Dec 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, cisplatin and paclitaxel in people with Cervical Cancer, run by Radiation Therapy Oncology Group at 125 sites in 4 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, South Korea, Canada, Hong Kong. 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?

Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (Percentage of Participants Alive Without Disease) (time frame: From randomization to first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Maximum follow-up at the time of analysis was 12.8 years. The 2- and 4-year DFS estimates are reported.). 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 NCT00980954.

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 31 Dec 2025.

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