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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
Open (Enrolling)
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


- 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

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

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

Inclusion Criteria


- 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

- 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

- 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)


- 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

- 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


- No history of allergy to cisplatin (cervical cancer patients)

- No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for
≥ 3 years


- See Disease Characteristics

- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy

- 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:


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:


Principal Investigator

Anuja Jhingran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




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



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CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
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West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
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Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
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Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Monmouth Medical Center Long Branch, New Jersey  07740-6395
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
City of Hope Comprehensive Cancer Center Duarte, California  91010
Veterans Affairs Medical Center - San Diego San Diego, California  92161
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
American Fork Hospital American Fork, Utah  84003
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
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  10027
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Eden Medical Center Castro Valley, California  94546
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
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Galesburg Cottage Hospital Galesburg, Illinois  61401
InterCommunity Cancer Center of Western Illinois Galesburg, Illinois  61401
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Hopedale Medical Complex Hopedale, Illinois  61747
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BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
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Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
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Perry Memorial Hospital Princeton, Illinois  61356
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Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
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Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
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Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Highland General Hospital Oakland, California  94602
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Huron Hospital Cancer Care Center Cleveland, Ohio  44112
Euclid Hospital Cleveland, Ohio  44119
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem, Ohio  44460
South Pointe Hospital Cancer Care Center Warrensville Heights, Ohio  44122
Cancer Treatment Center Wooster, Ohio  44691
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Reid Hospital & Health Care Services Richmond, Indiana  47374
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Clinton Memorial Hospital Wilmington, Ohio  45177
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
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
Solano Radiation Oncology Center Vacaville, California  95687
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
Galesburg Clinic, PC Galesburg, Illinois  61401
Providence Medical Center Kansas City, Kansas  66112
Johnson County Radiation Therapy Overland Park, Kansas  66210
Independence Regional Health Center Independence, Missouri  64050
Kansas City Cancer Center at St. Joseph's Medical Mall Kansas City, Missouri  64114
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Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center Kansas City, Missouri  64154
Mercy General Hospital Sacramento, California  95819
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Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
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Valley Medical Oncology Consultants - Pleasanton Pleasanton, California  94588
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Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields Olympia Fields, Illinois  60461
Bay Medical Panama City, Florida  32401
Oncology Center at Saint Margaret Mercy Healthcare Center Hammond, Indiana  46320
Cancer Institute of Cape Girardeau, LLC Cape Girardeau, Missouri  63703
South Shore Hospital South Weymouth, Massachusetts  02190
Cancer Institute of New Jersey at Cooper University Hospital - Camden Camden, New Jersey  08103
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care Center Milwaukee, Wisconsin  53211
Central Maine Comprehensive Cancer Center at Central Maine Medical Center Lewiston, Maine  04240
Radiation Oncology Associates, PA Albuquerque, New Mexico  87109
Auburn Radiation Oncology Auburn, California  95603
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Cancer Institute of New Mexico Santa Fe, New Mexico  87505