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A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity, Sexuality and Reproductive Issues

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Trial Information

A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial


OBJECTIVES:

Primary

- To determine if the addition of adjuvant chemotherapy to standard cisplatin-based
chemoradiation improves overall survival.

Secondary

- To determine the progression-free survival rates.

- To determine acute and long-term toxicities.

- To determine patterns of disease recurrence.

- To determine the association between radiation protocol compliance and outcomes.

- To determine patient quality of life, including psycho-sexual health.

Tertiary

- To determine the association between the results of a follow-up PET scan performed 4 -
6 months post completion of chemoradiation and outcomes for all patients in the trial.

- To determine the biological predictors of patients' outcomes based on translational
laboratory studies of blood and tissue specimens.

OUTLINE: This is a multicenter study. Patients are stratified according to pelvic or common
iliac nodal involvement (yes vs no), requirement for extended-field radiotherapy treatment
(yes vs no), FIGO stage (IB/IIA vs IIB vs IIIB/IVA), age (< 60 years of age vs ≥ 60 years of
age), and hospital/site. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29.
Patients also undergo external-beam radiation therapy once daily, 5 days a week, for
approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or
low-dose rate intracavitary brachytherapy.

- Arm II: Patients receive cisplatin and undergo external-beam radiation and
brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant
chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on
day 1. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.

Patients may undergo baseline tumor biopsy and blood collection for future correlative
studies.

Patients complete the European Organization for Research and Treatment of Cancer (EORTC)
Core questionnaire (QLQ-C30), the EORTC cervix cancer module (CX24), the ovarian cancer
module (OV28), and the Sexual function-Vaginal Changes Questionnaire (SVQ) questionnaires at
baseline, during, and after completion of study treatment.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Eligible patients will have locally advanced cervical cancer suitable for primary
treatment with chemoradiation with curative intent, in addition to:

- Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or
adenosquamous cell carcinoma of the cervix

- FIGO 2008 stage IB1 & node positive, IB2, II, IIIB, or IVA disease

- No patients assessed at presentation as requiring interstitial brachytherapy
treatment

- No para-aortic nodal involvement above the level of the common iliac nodes or L3/L4
(if biopsy proven, PET positive, or ≥ 15 mm short-axis diameter on CT)

- No evidence of distant metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- WBC ≥ 3,000/mm³

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

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

- AST/ALT ≤ 2.5 times ULN

- Creatinine ≤ ULN (CTC Grade 0) OR calculated creatinine clearance ≥ 60 mL/min OR ≥ 50
mL/min by EDTA creatinine clearance

- No patients with bilateral hydronephrosis unless at least one side has been stented
and renal function fulfils the required inclusion criteria

- No prior diagnosis of Crohn disease or ulcerative colitis

- No peripheral neuropathy ≥ grade 2 (per CTCAE v. 4)

- No patients with other invasive malignancies, with the exception of non-melanoma skin
cancer and in situ melanoma, who had (or have) any evidence of the other cancer
present within the last 5 years

- No patients who are pregnant or lactating

- No serious illness or medical condition that precludes the safe administration of the
trial treatment including, but not limited to, ongoing or active infection,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study
requirements

- Not HIV positive

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior pelvic radiotherapy

- No prior chemotherapy for this tumor

- No patients who have undergone prior hysterectomy or will have a hysterectomy as part
of their initial cervical cancer therapy

- No patients with any contraindication to cisplatin, carboplatin, or paclitaxel
chemotherapy

- No concurrent intensity-modulated radiation therapy or interstitial brachytherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival rate at 5 years

Safety Issue:

No

Principal Investigator

Kathleen N. Moore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

Unspecified

Study ID:

CDR0000706698

NCT ID:

NCT01414608

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Chemotherapeutic Agent Toxicity
  • Cognitive/Functional Effects
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • Sexuality and Reproductive Issues
  • sexuality and reproductive issues
  • radiation toxicity
  • chemotherapeutic agent toxicity
  • psychosocial effects of cancer and its treatment
  • cognitive/functional effects
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • stage IIB cervical cancer
  • stage III cervical cancer
  • stage IVA cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • Uterine Cervical Neoplasms
  • Radiation Injuries

Name

Location

MBCCOP - Hawaii Honolulu, Hawaii  96813
University of Chicago Cancer Research Center Chicago, Illinois  60637
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield, Massachusetts  01199
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
United Hospital St. Paul, Minnesota  55102
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Ochsner New Orleans, Louisiana  70121
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
LDS Hospital Salt Lake City, Utah  84143
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Milwaukee, Wisconsin  53201-2901
University of California Davis Cancer Center Sacramento, California  95817
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
SUNY Downstate Medical Center Brooklyn, New York  11203
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
Central Baptist Hospital Lexington, Kentucky  40503
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Maine Medical Center - Bramhall Campus Portland, Maine  04102
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
John Muir/Mt. Diablo Comprehensive Cancer Center Walnut Creek, California  94598
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Palo Alto Medical Foundation Palo Alto, California  94301
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Billings Clinic - Downtown Billings, Montana  59107-7000
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
St. Luke's Cancer Network at St. Luke's Hospital Bethlehem, Pennsylvania  18015
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Green Bay, Wisconsin  54311
Gynecologic Oncology Hinsdale, Illinois  60521
Women's Cancer Center - La Canada Las Vegas, Nevada  89169
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune, New Jersey  07754-0397
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
Southwest Gynecologic Oncology Associates, Incorporated Albuquerque, New Mexico  87102
Women's Cancer Care Associates Albany, New York  12208
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin  54904
Lyndon B. Johnson General Hospital Houston, Texas  77026-1967
St. Vincent Oncology Center Indianapolis, Indiana  46260