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A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine (IND #46525) and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis

Phase 3
18 Years
Open (Enrolling)
Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer

Thank you

Trial Information

A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine (IND #46525) and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis


I. Compare the progression-free survival of patients with stage IB, IIA, IIB, IIIB, or IVA
carcinoma of the cervix treated with cisplatin and radiotherapy with vs without


I. Compare overall survival of patients treated with these regimens. II. Compare the
toxicity of these regimens in these patients.


I. Correlate study treatment with tumor expression of carbonic anhydrase IX (CA-IX) and
recurrence-free survival, overall survival, or metastasis in patients treated with these

II. Correlate expression of CA-IX, hypoxia inducible factor-1α, CD-31, thrombospondin-1,
CD-105, or vascular endothelial growth factor (VEGF) in primary tumor tissue with
recurrence-free survival, overall survival, or metastasis in patients treated with these

III. Correlate pre-treatment and/or post-treatment serum concentrations of angiogenic
markers including angiogenin or VEGF with recurrence-free survival, overall survival, or
metastasis in patients treated with these regimens.

IV. Correlate various combinations of biological markers of hypoxia and angiogenesis with
recurrence-free survival, overall survival, or metastasis in patients treated with these

V. Correlate levels of individual biological markers of hypoxia or angiogenesis with
clinicopathological characteristics including tumor size, histologic subtype, FIGO stage,
depth of invasion, pelvic node status, site of recurrence, and hemoglobin level as well as
patient, age, race and performance status in patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to FIGO stage of disease (IB2 vs IIA vs IIB vs IIIB vs IVA), brachytherapy method
(low-dose rate vs high-dose rate), surgical staging of para-aortic nodes (yes vs no).
Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin IV over 30-60 minutes once weekly on days 1, 8, 15, 22,
29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the pelvis once
daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1
or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose
rate (HDR)* brachytherapy once weekly in weeks 4-8 and 3-5 days of parametrial boost
radiotherapy** beginning after the first brachytherapy implant. Treatment continues in the
absence of disease progression or unacceptable toxicity.

ARM II: Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26,
and 29 and cisplatin IV over 1 hour on days 1, 15, and 29. Patients also undergo
radiotherapy and brachytherapy as in arm I. Treatment continues in the absence of disease
progression or unacceptable toxicity.

NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the
majority of external beam radiotherapy has been administered, HDR brachytherapy may be
administered in 2 applications per week (separated by at least 72 hours) in order to
complete all treatment within 8 weeks.

NOTE: ** Patients may receive a parametrial boost at the discretion of the treating
radiation oncologist.

After completion of study treatment, patients are followed for at least 5 years.

Inclusion Criteria:

- Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or
adenosquamous cell carcinoma of the uterine cervix

- Stage IB2, IIA, IIB, IIIB, or IVA disease

- Stage IIA tumors must be > 4 cm

- Primary, untreated disease

- Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or

- Must have been adequately clinically staged

- Suitable for treatment with radical intent using concurrent chemotherapy and pelvic

- No disease involvement of the lower third of the vagina regardless of stage (all
stage IIIA, IIIB and IVA with lower one-third involvement)

- No carcinoma of the cervical stump

- Performance status - GOG 0-3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

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

- SGOT ≤ 3 times ULN

- Alkaline phosphatase ≤ 3 times ULN

- Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min

- No New York Heart Association class III-IV heart failure

- No history of myocardial infarction

- No unstable angina

- No uncontrolled hypertension

- No pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No septicemia or severe infection

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

- No prior hysterectomy or planned hysterectomy as part of initial cervix cancer

- No prior coronary artery bypass surgery

- No prior cancer therapy that would preclude study treatment

- No concurrent angina medication

- No concurrent intensity-modulated radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Paul DiSilvestro

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Stage IB Cervical Cancer
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage IVA Cervical Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Carcinoma, Adenosquamous



Louisiana State UniversityNew Orleans, Louisiana  70112-2282
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo ClinicRochester, Minnesota  55905
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Abington Memorial HospitalAbington, Pennsylvania  19001
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Memorial Hospital of South BendSouth Bend, Indiana  46601
Community Medical CenterToms River, New Jersey  08755
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Lehigh Valley HospitalAllentown, Pennsylvania  18103
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
University of Texas Medical BranchGalveston, Texas  77555-1329
LDS HospitalSalt Lake City, Utah  84143
Rush University Medical CenterChicago, Illinois  60612-3824
North Shore University HospitalManhasset, New York  11030
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Hartford HospitalHartford, Connecticut  06102-5037
Eastern Maine Medical CenterBangor, Maine  04401
Providence Alaska Medical CenterAnchorage, Alaska  99508
William Beaumont HospitalRoyal Oak, Michigan  48073
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Via Christi Regional Medical CenterWichita, Kansas  67214
Wesley Medical CenterWichita, Kansas  67214
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Great Falls ClinicGreat Falls, Montana  59405
MetroHealth Medical CenterCleveland, Ohio  44109
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
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Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
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Good Samaritan Hospital - CincinnatiCincinnati, Ohio  45220
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
City of Hope Medical CenterDuarte, California  91010
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Beebe Medical CenterLewes, Delaware  19958
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Bethesda North HospitalCincinnati, Ohio  45242
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Mayo Clinic in FloridaJacksonville, Florida  32224
Washington Hospital CenterWashington, District of Columbia  20010
Memorial Medical CenterSpringfield, Illinois  62781
Metro Health HospitalGrand Rapids, Michigan  49506
Queen's Medical CenterHonolulu, Hawaii  96813
University of VirginiaCharlottesville, Virginia  22908
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Vanderbilt UniversityNashville, Tennessee  37232-6305
University of North CarolinaChapel Hill, North Carolina  27599
Duke University Medical CenterDurham, North Carolina  27710
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Saint Louis University HospitalSt. Louis, Missouri  63110-0250
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Yale UniversityNew Haven, Connecticut  06520
Wayne State UniversityDetroit, Michigan  48202
Straub Clinic and HospitalHonolulu, Hawaii  96813
University of Massachusetts Medical SchoolWorcester, Massachusetts  01605
Riverside Methodist HospitalColumbus, Ohio  43214
Mid Dakota ClinicBismarck, North Dakota  58501
Indiana University Medical CenterIndianapolis, Indiana  46202
University of Texas Southwestern Medical CenterDallas, Texas  
Wichita CCOPWichita, Kansas  67214-3882
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Providence HospitalSouthfield, Michigan  48075
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Good Samaritan Hospital Medical CenterWest Islip, New York  11795
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
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M D Anderson Cancer CenterHouston, Texas  77030
DeKalb Medical CenterDecatur, Georgia  30033
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Chattanooga's Program in Women's OncologyChattanooga, Tennessee  37403
Northern Virginia Pelvic Surgery AssociatesAnnandale, Virginia  22003
University of CincinnatiCincinnati, Ohio  45267-0502
Hawaii Medical Center EastHonolulu, Hawaii  96817
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
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OSF Saint Francis Medical CenterPeoria, Illinois  61637
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Bay Area Tumor Institution CCOPOakland, California  94609
Memorial Hospital Colorado SpringsColorado Springs, Colorado  80909
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
John B Amos Cancer CenterColumbus, Georgia  31904
Wellstar Kennestone HospitalMarietta, Georgia  30060
University of HawaiiHonolulu, Hawaii  96813
Rush - Copley Medical CenterAurora, Illinois  60504
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Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
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Spectrum Health-Blodgett CampusGrand Rapids, Michigan  49506
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
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Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Mercy Health Partners-Hackley CampusMuskegon, Michigan  49442
Lakeland HospitalSt. Joseph, Michigan  49085
Radiation Oncology Practice Corporation - NorthKansas City, Missouri  64154
Radiation Oncology Practice Corporation SouthKansas City, Missouri  64114
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
Saint John's Mercy Medical CenterSaint Louis, Missouri  63141
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
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Cox Medical CenterSpringfield, Missouri  65807
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Good Samaritan HospitalKearney, Nebraska  68847
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Orange Regional Medical CenterMiddletown, New York  10940
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Cancer Care Associates-MidtownTulsa, Oklahoma  74104
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Lake University Ireland Cancer CenterMentor, Ohio  44060
University of IllinoisChicago, Illinois  60612
Stony Brook University Medical CenterStony Brook, New York  11794
University of Missouri - Ellis FischelColumbia, Missouri  65203
Renown Regional Medical CenterReno, Nevada  89502
UMDNJ - New Jersey Medical SchoolNewark, New Jersey  07103
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Dixie Medical Center Regional Cancer CenterSaint George, Utah  84770
Intermountain Health CareSalt Lake City, Utah  84103
Utah Cancer Specialists-Salt Lake CitySalt Lake City, Utah  84106
Washington Regional Medical Center - FayettevilleFayetteville, Arkansas  72703
Highlands Oncology Group PA - FayettevilleFayetteville, Arkansas  72703
Olive View-University of California Los Angeles Medical CenterSylmar, California  91342
Hawaii Minority Based CCOPHonolulu, Hawaii  96813
Advocate Lutheran General HospitalPark Ridge, Illinois  60068
Saint Elizabeth Medical Center SouthEdgewood, Kentucky  41017
Maine Medical Center-Bramhall CampusPortland, Maine  04102
Gynecologic Oncology of West Michigan PLLCGrand Rapids, Michigan  49546
Center of Hope at Renown Medical CenterReno, Nevada  89502
Montefiore Medical Center-Weiler DivisionBronx, New York  10461
State University of New York Downstate Medical CenterBrooklyn, New York  11203
Monter Cancer CenterLake Success, New York  11042
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East Tennessee State UniversityJohnson City, Tennessee  37614-0054
Texas Tech University Health Sciences CenterLubbock, Texas  79430
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Carilion Clinic Gynecological OncologyRoanoke, Virginia  24016
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Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Georgia Health Sciences UniversityAugusta, Georgia  30912
Jonsson Comprehensive Cancer CenterLos Angeles, California  90095
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
North Shore-LIJ Health System CCOPManhasset, New York  11030
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Bronson Battle CreekBattle Creek, Michigan  49017
Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Ohio  44111
The James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Women's Cancer Care Associates LLCAlbany, New York  12208
Island Gynecologic OncologyBrightwaters, New York  11718
Fletcher Allen Health Care-Medical CenterBurlington, Vermont  05401