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A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma

Phase 3
18 Years
Open (Enrolling)
Endometrial Cancer, Fatigue, Neurotoxicity

Thank you

Trial Information

A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma



- To compare the recurrence-free survival of patients with high-risk stage I or II
endometrial carcinoma treated with pelvic radiotherapy vs vaginal cuff brachytherapy,
paclitaxel, and carboplatin.


- To compare survival of patients treated with these regimens.

- To compare patterns of failure in patients treated with these regimens.

- To compare physical functioning, fatigue, and neurotoxicity in patients treated with
these regimens.

- To correlate primary comorbid illnesses and obesity with survival, fatigue, and
physical functioning.

- To evaluate the psychometric properties (e.g., construct validity, reliability,
sensitivity to treatment, and responsiveness over time) of the PROMIS Fatigue-SF1.

- To evaluate fatigue measurement equivalence between patients with endometrial cancer
and age-matched women from the general population of the United States.

OUTLINE: This is a multicenter study. Patients are stratified according to extent of surgery
(hysterectomy and bilateral salpingo-oophorectomy without lymph node sampling, lymph node
dissection, or lymphadenectomy vs hysterectomy and bilateral salpingo-oophorectomy with
lymph node sampling, lymph node dissection, or lymphadenectomy). Patients with stage II
disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous
histology who are randomized to arm I are also stratified according to intent to use vaginal
cuff brachytherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo conventional or intensity-modulated pelvic radiotherapy once
daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of
disease progression or unacceptable toxicity. Patients with stage II disease or stage I
disease with a confirmed diagnosis of clear cell and/or papillary serous histology may
also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.

- Arm II: Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate
brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate
brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating
brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over
30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the
absence of disease progression or unacceptable toxicity.

Patients complete questionnaires to assess quality of life, neurotoxicity, and fatigue at
baseline, 4 weeks, 10-11 weeks, 8 months, and 14 months.

After completion of study therapy, patients are followed periodically for up to 10 years.

Inclusion Criteria


- Diagnosis of endometrial carcinoma, meeting 1 of the following criteria:

- Stage I disease with high-intermediate risk factors with positive or negative
cytology (e.g., grade 2 or 3 tumor, presence of lymphovascular space invasion,
and/or outer half myometrial invasion), meeting 1 of the following criteria:

- Age ≥ 70 years with 1 risk factor

- Age ≥ 50 years with 2 risk factors

- Age ≥ 18 years with 3 risk factors

- Stage II (occult or gross involvement) disease (any histology) with or without
risk factors

- Occult disease is defined as lesions that are identified as an incidental
finding after hysterectomy in the absence of gross cervical disease

- Stage I-II disease with serous or clear cell histology with or without other
risk factors allowed provided the disease is uterine-confined (with or without
cervical stromal invasion or endocervical glandular involvement), and with
peritoneal cytology negative for malignancy

- Has undergone hysterectomy and bilateral salpingo-oophorectomy (laparotomy or
laparoscopic approach, including robot-assisted) with or without pelvic and
para-aortic lymphadenectomy within the past 4-12 weeks

- If nodal dissection was not performed, pelvic and para-aortic nodes must be
clinically negative with no evidence of distant disease by post-operative,
pre-treatment CT scan/MRI

- Suspicious nodes that have been biopsied (re-staging surgery, fine-needle
aspiration) allowed provided they are pathologically negative

- No pathologically confirmed spread of disease to pelvic or para-aortic lymph
nodes or adnexal structures, and/or other anatomic sites, or serous or clear
cell histology and positive cytologic washings

- No recurrent disease

- No surgical or clinical stage III or IV endometrial carcinoma

- No sarcoma, carcinosarcoma (i.e., malignant mixed mullerian tumor), or non-epithelial
uterine malignancies (i.e., leiomyosarcoma of the uterine corpus)


- GOG performance status 0-2

- ANC ≥ 1,500/mcl

- Platelet count ≥ 100,000/mcl

- Serum creatinine normal OR creatinine clearance > 50 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- No neuropathy (sensory or motor) > grade 1

- No other invasive malignancy within the past 5 years except non-melanoma skin cancer

- No contraindications to pelvic radiotherapy (e.g., pelvic kidney, connective tissue
disease, or inflammatory bowel disease)


- See Disease Characteristics

- No prior non-surgical therapy for endometrial cancer, including chemotherapy,
radiotherapy (e.g., pre-operative or post-operative brachytherapy), hormonal therapy,
or biological therapy

- No prior systemic chemotherapy or radiotherapy for another malignancy

- No concurrent whole-abdominal, extended-field, or interstitial radiotherapy

- No concurrent erythropoietin therapy

- Concurrent enrollment on GOG-0210 (molecular marker study) allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Duration of recurrence-free survival

Safety Issue:


Principal Investigator

D. Scott McMeekin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute



Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Fatigue
  • Neurotoxicity
  • fatigue
  • neurotoxicity
  • endometrial clear cell carcinoma
  • endometrial papillary serous carcinoma
  • endometrial adenoacanthoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • stage IA endometrial carcinoma
  • stage IB endometrial carcinoma
  • stage II endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Fatigue
  • Adenoma
  • Neurotoxicity Syndromes



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Duke Cancer InstituteDurham, North Carolina  27710
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Pacific Gynecology SpecialistsSeattle, Washington  98104
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Providence Cancer CenterAnchorage, Alaska  99508
Rockwood Clinic Cancer Treatment CenterSpokane, Washington  99204-2967
Solano Radiation Oncology CenterVacaville, California  95687
Tyler Cancer CenterTyler, Texas  75702
Gynecologic OncologyHinsdale, Illinois  60521
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
Good Samaritan Hospital Cancer Treatment CenterCincinnati, Ohio  45220
Mercy General HospitalSacramento, California  95819
Valley Hospital - RidgewoodRidgewood, New Jersey  07450
United States Air Force Medical Center - Wright-PattersonWright-Patterson AFB, Ohio  45433-5529
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
AnMed Cancer CenterAnderson, South Carolina  29621
U.T. Medical Center Cancer InstituteKnoxville, Tennessee  37920-6999
Fountain Valley, California  92708
Olive View - UCLA Medical Center FoundationSylmar, California  91342
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Cancer Centers of North Carolina - RaleighRaleigh, North Carolina  27607
Jersey Shore Cancer Center at Jersey Shore University Medical CenterNeptune, New Jersey  07754-0397
Duke Health Raleigh HospitalRaleigh, North Carolina  27609
Northwest Hospital and Medical CenterSeattle, Washington  98133
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Cancer Centers of the Carolinas - Greer Radiation OncologyGreer, South Carolina  29650
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
West Texas Cancer CenterOdessa, Texas  79761
Central Georgia Gynecologic OncologyMacon, Georgia  31201
Oncology Hematology Care, Incorporated - Blue AshCincinnati, Ohio  45242
St. Mary Regional Cancer Center at St. Mary Medical CenterWalla Walla, Washington  99362
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Harrison Medical CenterBremerton, Washington  98310
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Kaiser Permanente - Division of Research - OaklandOakland, California  94611
Rohnert Park Cancer CenterRohnert Park, California  94928
CCOP - Kansas CityPrairie Village, Kansas  66208
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Sands Cancer CenterCanandiaqua, New York  14424
University Radiation Oncology at Parkridge HospitalRochester, New York  14626
Florida Gynecologic Oncology - Fort MyersFort Myers, Florida  33905
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546
Southwest Gynecologic Oncology Associates, IncorporatedAlbuquerque, New Mexico  87102
Women's Cancer Care AssociatesAlbany, New York  12208
Black Hills Obstetrics & Gynecology LLPRapid City, South Dakota  57701
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Vince Lombardi Cancer Clinic - OshkoshOshkosh, Wisconsin  54904
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Tufts Medical Center Cancer CenterBoston, Massachusetts  02111
Longview Cancer CenterLongview, Texas  75601
Chattanooga GYN-OncologyChattanooga, Tennessee  37403
Central Dupage Cancer CenterWarrenville, Illinois  60555
University of New Mexico Cancer Center - SouthLas Cruces, New Mexico  88011
Littleton Adventist HospitalLittleton, Colorado  80122
Parker Adventist HospitalParker, Colorado  80138
Roger Maris Cancer Center at MeritCare HospitalFargo, North Dakota  58122
Central Indiana Cancer Centers - EastIndianapolis, Indiana  46219
Willamette Valley Cancer Center - EugeneEugene, Oregon  97401
Texas Oncology, PA at Harris Center HEBBedford, Texas  76022
Texas Oncology, PA at Texas Cancer Center - Denton SouthDenton, Texas  76210
Klabzuba Cancer Center at Harris Methodist Fort Worth HospitalFort Worth, Texas  76104
Texas Oncology, PA at Texas Cancer Center - ShermanSherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar LandSugar Land, Texas  77479
Women's Cancer AssociatesSaint Petersburg, Florida  33701
New York Hospital Medical Center of Queens - Fresh MeadowsFresh Meadows, New York  11365
Arizona Oncology - TucsonTucson, Arizona  85704
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331
Providence Regional Cancer PartnershipEverett, Washington  98201
St. Vincent Oncology CenterIndianapolis, Indiana  46260
Texas Oncology, PA at Texas Cancer Center - Arlington SouthArlington, Texas  76014
All Saints Episcopal Hospital - Fort WorthFort Worth, Texas  76104
Leonard Lawson Cancer Center at Pikeville Medical CenterPikeville, Kentucky  41501
Women's Institute for Gynecologic Cancer and Special Pelvic SurgeryPhillipsburg, New Jersey  08865
PeaceHealth Medical Group, PC at St. Joseph HospitalBellingham, Washington  98226
Olympic Medical Cancer CenterSequim, Washington  98382