AzTrials
AzTrials

Cervical CancerPhase 2NCT00331760

Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery

A Phase 2 study testing cisplatin and intensity-modulated radiation therapy in people with Cervical Cancer and Endometrial Cancer, run by Radiation Therapy Oncology Group at 153 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: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer, Endometrial Cancer
What is being tested?
cisplatin and intensity-modulated radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
153 sitesin 2 countries
Study dates
Mar 2006to Dec 2016
Phase
Phase 2
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:

  • Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) within 7 weeks prior to study entry
  • Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy
  • Histologically confirmed diagnosis of 1 of the following:
  • Endometrial cancer meeting 1 of the following criteria:
  • Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
  • Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
  • Stage IIIC with all of the following:
  • Pelvic lymph node positive only
  • Para-aortic nodes sampled negative
  • Not receiving chemotherapy
  • Cervical cancer meeting 1 of the following criteria:
  • Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:
  • Positive pelvic nodes (negative para-aortic nodes)
  • Microscopic parametrial involvement and negative margins
  • Disease qualified by Sedlis criteria must have 2 of the following risk factors:
  • 1/3 or more stromal invasion
  • Lymph-vascular space invasion
  • Large clinical tumor diameter (≥ 4 cm)
  • Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
  • No requirement for extended-field radiotherapy beyond the pelvis
  • No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
  • No evidence of metastatic disease outside of the pelvis
  • No microscopic involvement of the resection margin (< 3 mm)

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • WBC (white blood cell count) ≥ 4,000/mm³ (cervical cancer patients only)
  • Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
  • Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
  • Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
  • AST (aspartate aminotransferase) ≤ 2 times upper limit of normal
  • Bilirubin ≤ 2 times upper limit of normal
  • Patients must not exceed the weight and size limits of the treatment table or CT scanner
  • No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions
  • No active inflammatory bowel disease
  • No severe, active, concurrent illness, defined as 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
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS
  • No history of allergy to cisplatin (cervical cancer patients)
  • No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
  • No prior platinum-based chemotherapy (cervical cancer patients)
  • No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or pegfilgrastim)
  • No concurrent prophylactic thrombopoietic agents
  • No concurrent amifostine or other protective agents

Trial locations and contacts

153 sites in 2 countries.

153 sites in 2 countries

United States151 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Lovelace Medical Center - Downtown

    Albuquerque, New Mexico, 87102

  • Radiation Oncology Associates, PA

    Albuquerque, New Mexico, 87109

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

  • American Fork Hospital

    American Fork, Utah, 84003

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • Auburn Radiation Oncology

    Auburn, California, 95603

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

    Beech Grove, Indiana, 46107

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Camden, New Jersey, 08103

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Graham Hospital

    Canton, Illinois, 61520

  • Cancer Institute of Cape Girardeau, LLC

    Cape Girardeau, Missouri, 63703

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Memorial Hospital

    Carthage, Illinois, 62321

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Huron Hospital Cancer Care Center

    Cleveland, Ohio, 44112

  • Euclid Hospital

    Cleveland, Ohio, 44119

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • 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

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Union Hospital Cancer Program at Union Hospital

    Elkton, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Valley Medical Oncology

    Fremont, California, 94538

  • Galesburg Clinic, PC

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Oncology Center at Saint Margaret Mercy Healthcare Center

    Hammond, Indiana, 46320

  • Mason District Hospital

    Havana, Illinois, 62644

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Independence Regional Health Center

    Independence, Missouri, 64050

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Kansas City Cancer Center at St. Joseph's Medical Mall

    Kansas City, Missouri, 64114

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center

    Kansas City, Missouri, 64154

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Maine Comprehensive Cancer Center at Central Maine Medical Center

    Lewiston, Maine, 04240

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • Columbia-Saint Mary's Cancer Care Center

    Milwaukee, Wisconsin, 53211

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08903

  • Beth Israel Medical Center - Petrie Division

    New York, New York, 10003-3803

  • St. Luke's - Roosevelt Hospital Center - St.Luke's Division

    New York, New York, 10025

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Southwest Virginia Regional Cancer Center at Wellmonth Health

    Norton, Virginia, 24273

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

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

    Olympia Fields, Illinois, 60461

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Johnson County Radiation Therapy

    Overland Park, Kansas, 66210

  • Bay Medical

    Panama City, Florida, 32401

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61615-7827

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants - Pleasanton

    Pleasanton, California, 94588

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • South Suburban Oncology Center

    Quincy, Massachusetts, 02169

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • Mercy General Hospital

    Sacramento, California, 95819

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

    Salem, Ohio, 44460

  • LDS Hospital

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Cancer Institute of New Mexico

    Santa Fe, New Mexico, 87505

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Solano Radiation Oncology Center

    Vacaville, California, 95687

  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

    Vineland, New Jersey, 08360

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • South Pointe Hospital Cancer Care Center

    Warrensville Heights, Ohio, 44122

  • University of Wisconcin Cancer Center at Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • CCOP - Main Line Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

Canada2 sites

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H2W 1S6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma

RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy (IMRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.

Read the detailed description

OBJECTIVES:

  • Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer.
  • Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments.
  • Assess adverse events related to this regimen.
  • Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival.
  • Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).

All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

Being tested
cisplatin, intensity-modulated radiation therapy
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, endometrial adenoacanthoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms

What participants receive

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

  • cisplatinDrug

  • intensity-modulated radiation therapyRadiation

Study groups in NCT00331760
Study groupRoleWhat they receive
Endometrial Cancer: IMRTOtherEndometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
Receives: Radiation: intensity-modulated radiation therapy
Cervical Cancer: IMRT + Chemotherapy (cisplatin)OtherCervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m^2 for five weeks.
Receives: Drug: cisplatin; Radiation: intensity-modulated radiation therapy

What is being measured

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

  1. Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)

    Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%.

    For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%.

    Measured: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.

Secondary outcomes (8)

  1. Percentage of Patients With Grade 2+ Bowel Adverse Events

    Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.

    Measured: From the start of treatment to 90 days.

  2. Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events

    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.

    Measured: From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.

  3. Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events

    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.

    Measured: From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.

  4. Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant

    Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.

    Measured: From start to end of chemotherapy, approximately five weeks from registration.

  5. Rate of Local-regional Failure at Five Years

    Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.

    Measured: From registration to five years.

  6. Rate of Distant Metastases at Five Years

    Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.

    Measured: From registration to five years

  7. Rate of Disease-free Survival at Five Years

    Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.

    Measured: From registration five years

  8. Rate of Overall Survival at Five Years

    Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

    Measured: From randomization to five years

Timeline

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

  1. First posted31 May 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionFeb 2009
  4. Study completionDec 2016

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00331760
Sponsor's protocol ID
RTOG-0418
Other IDs
CDR0000472905
Status last verified
Feb 2019
First submitted
30 May 2006
Last updated
26 Feb 2019
Data monitoring committee
Yes

Publications

  • Jhingran A, Winter K, Portelance L, Miller B, Salehpour M, Gaur R, Souhami L, Small W Jr, Berk L, Gaffney D. A phase II study of intensity modulated radiation therapy to the pelvis for postoperative patients with endometrial carcinoma: radiation therapy oncology group trial 0418. Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):e23-8. doi: 10.1016/j.ijrobp.2012.02.044. Epub 2012 Apr 28.

    PubMed 22543211

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and intensity-modulated radiation therapy in people with Cervical Cancer and Endometrial Cancer, run by Radiation Therapy Oncology Group at 153 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 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 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?

Yes. Results are posted in the registry (first posted 3 Jun 2013). 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?

Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review) (time frame: IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.). 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 NCT00331760, which also lists 1 linked publication.

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 26 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in