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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
Open (Enrolling)
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



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


- 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.


- 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

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


- 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

- 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


- 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

- Not HIV positive


- 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

- No concurrent intensity-modulated radiation therapy or interstitial brachytherapy

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival rate at 5 years

Safety Issue:


Principal Investigator

Kathleen N. Moore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oklahoma University Cancer Institute



Study ID:




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



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SUNY Downstate Medical Center Brooklyn, New York  11203
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Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
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Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
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Palo Alto Medical Foundation Palo Alto, California  94301
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Billings Clinic - Downtown Billings, Montana  59107-7000
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
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St. Luke's Cancer Network at St. Luke's Hospital Bethlehem, Pennsylvania  18015
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