A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial
18 Years
N/A
Female
Cervical Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity, Sexuality and Reproductive Issues
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 |
