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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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Heartland Regional Medical Center Saint Joseph, Missouri  64506
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York Cancer Center at Apple Hill Medical Center York, Pennsylvania  17405
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
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John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Community Hospital Munster, Indiana  46321
Methodist Hospital Houston, Texas  77030
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St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
St. Vincent's Medical Center Bridgeport, Connecticut  06606
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Elliot Regional Cancer Center at Elliot Hospital Manchester, New Hampshire  03103
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Bethesda North Hospital Cincinnati, Ohio  45242
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Union Hospital of Cecil County Elkton MD, Maryland  21921
Duke Cancer Institute Durham, North Carolina  27710
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Pacific Gynecology Specialists Seattle, Washington  98104
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MBCCOP - Meharry Medical College - Nashville Nashville, Tennessee  37208-3599
Providence Cancer Center Anchorage, Alaska  99508
Rockwood Clinic Cancer Treatment Center Spokane, Washington  99204-2967
Solano Radiation Oncology Center Vacaville, California  95687
Tyler Cancer Center Tyler, Texas  75702
Gynecologic Oncology Hinsdale, Illinois  60521
Women's Cancer Center - La Canada Las Vegas, Nevada  89169
Good Samaritan Hospital Cancer Treatment Center Cincinnati, Ohio  45220
Mercy General Hospital Sacramento, California  95819
Valley Hospital - Ridgewood Ridgewood, New Jersey  07450
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
AnMed Cancer Center Anderson, South Carolina  29621
U.T. Medical Center Cancer Institute Knoxville, Tennessee  37920-6999
Fountain Valley, California  92708
Olive View - UCLA Medical Center Foundation Sylmar, California  91342
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Cancer Centers of North Carolina - Raleigh Raleigh, North Carolina  27607
Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune, New Jersey  07754-0397
Duke Health Raleigh Hospital Raleigh, North Carolina  27609
Northwest Hospital and Medical Center Seattle, Washington  98133
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Cancer Centers of the Carolinas - Greer Radiation Oncology Greer, South Carolina  29650
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
West Texas Cancer Center Odessa, Texas  79761
Central Georgia Gynecologic Oncology Macon, Georgia  31201
Oncology Hematology Care, Incorporated - Blue Ash Cincinnati, Ohio  45242
St. Mary Regional Cancer Center at St. Mary Medical Center Walla Walla, Washington  99362
Auburn Radiation Oncology Auburn, California  95603
Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
Radiation Oncology Center - Roseville Roseville, California  95661
Harrison Medical Center Bremerton, Washington  98310
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608
Kaiser Permanente - Division of Research - Oakland Oakland, California  94611
Rohnert Park Cancer Center Rohnert Park, California  94928
CCOP - Kansas City Prairie Village, Kansas  66208
St. Agnes Hospital Cancer Center Baltimore, Maryland  21229
Renown Institute for Cancer at Renown Regional Medical Center Reno, Nevada  89502
Sands Cancer Center Canandiaqua, New York  14424
University Radiation Oncology at Parkridge Hospital Rochester, New York  14626
Florida Gynecologic Oncology - Fort Myers Fort Myers, Florida  33905
Gynecologic Oncology of West Michigan Grand Rapids, Michigan  49546
Southwest Gynecologic Oncology Associates, Incorporated Albuquerque, New Mexico  87102
Women's Cancer Care Associates Albany, New York  12208
Black Hills Obstetrics & Gynecology LLP Rapid City, South Dakota  57701
Aurora Women's Pavilion of West Allis Memorial Hospital West Allis, Wisconsin  53227
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin  54904
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Burbank, California  91505
Tufts Medical Center Cancer Center Boston, Massachusetts  02111
Longview Cancer Center Longview, Texas  75601
Chattanooga GYN-Oncology Chattanooga, Tennessee  37403
Central Dupage Cancer Center Warrenville, Illinois  60555
University of New Mexico Cancer Center - South Las Cruces, New Mexico  88011
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
Central Indiana Cancer Centers - East Indianapolis, Indiana  46219
Willamette Valley Cancer Center - Eugene Eugene, Oregon  97401
Texas Oncology, PA at Harris Center HEB Bedford, Texas  76022
Texas Oncology, PA at Texas Cancer Center - Denton South Denton, Texas  76210
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital Fort Worth, Texas  76104
Texas Oncology, PA at Texas Cancer Center - Sherman Sherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land Sugar Land, Texas  77479
Women's Cancer Associates Saint Petersburg, Florida  33701
New York Hospital Medical Center of Queens - Fresh Meadows Fresh Meadows, New York  11365
Arizona Oncology - Tucson Tucson, Arizona  85704
Arizona Cancer Center at University Medical Center North Tucson, Arizona  85719
Adams Cancer Center Gettysburg, Pennsylvania  17325
Cherry Tree Cancer Center Hanover, Pennsylvania  17331
Providence Regional Cancer Partnership Everett, Washington  98201
St. Vincent Oncology Center Indianapolis, Indiana  46260
Texas Oncology, PA at Texas Cancer Center - Arlington South Arlington, Texas  76014
All Saints Episcopal Hospital - Fort Worth Fort Worth, Texas  76104
Leonard Lawson Cancer Center at Pikeville Medical Center Pikeville, Kentucky  41501
Women's Institute for Gynecologic Cancer and Special Pelvic Surgery Phillipsburg, New Jersey  08865
PeaceHealth Medical Group, PC at St. Joseph Hospital Bellingham, Washington  98226
Olympic Medical Cancer Center Sequim, Washington  98382