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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Endometrial Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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%.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Anuja Jhingran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000472905

NCT ID:

NCT00331760

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • 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
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Cervical Neoplasms
  • Adenoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
LDS HospitalSalt Lake City, Utah  84143
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
American Fork HospitalAmerican Fork, Utah  84003
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Beth Israel Medical Center - Petrie DivisionNew York, New York  10003-3803
St. Luke's - Roosevelt Hospital Center - St.Luke's DivisionNew York, New York  10027
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Eden Medical CenterCastro Valley, California  94546
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Highland General HospitalOakland, California  94602
South Suburban Oncology CenterQuincy, Massachusetts  02169
Huron Hospital Cancer Care CenterCleveland, Ohio  44112
Euclid HospitalCleveland, Ohio  44119
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
South Pointe Hospital Cancer Care CenterWarrensville Heights, Ohio  44122
Cancer Treatment CenterWooster, Ohio  44691
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Clinton Memorial HospitalWilmington, Ohio  45177
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
Solano Radiation Oncology CenterVacaville, California  95687
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Galesburg Clinic, PCGalesburg, Illinois  61401
Providence Medical CenterKansas City, Kansas  66112
Johnson County Radiation TherapyOverland Park, Kansas  66210
Independence Regional Health CenterIndependence, Missouri  64050
Kansas City Cancer Center at St. Joseph's Medical MallKansas City, Missouri  64114
Parvin Radiation OncologyKansas City, Missouri  64116
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology CenterKansas City, Missouri  64154
Mercy General HospitalSacramento, California  95819
East Bay Radiation Oncology CenterCastro Valley, California  94546
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
Valley Medical Oncology Consultants - PleasantonPleasanton, California  94588
Alexian Brothers Radiation OncologyElk Grove Village, Illinois  60007
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois  60461
Bay MedicalPanama City, Florida  32401
Oncology Center at Saint Margaret Mercy Healthcare CenterHammond, Indiana  46320
Cancer Institute of Cape Girardeau, LLCCape Girardeau, Missouri  63703
South Shore HospitalSouth Weymouth, Massachusetts  02190
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103
Lovelace Medical Center - DowntownAlbuquerque, New Mexico  87102
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211
Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine  04240
Radiation Oncology Associates, PAAlbuquerque, New Mexico  87109
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Cancer Institute of New MexicoSanta Fe, New Mexico  87505