Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01414608
First received: August 10, 2011
Last updated: August 8, 2014
Last verified: August 2014

August 10, 2011
August 8, 2014
January 2012
July 2018   (final data collection date for primary outcome measure)
Overall survival rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
Described with Kaplan-Meier curves and unadjusted logrank tests.
Overall survival rate at 5 years [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01414608 on ClinicalTrials.gov Archive Site
  • Progression-free survival rate [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
  • Rate of acute and long-term toxicities [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Patterns of disease recurrence [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Radiation protocol compliance [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Quality of life including psychosexual health [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Progression-free survival rate at 3 and 5 years [ Designated as safety issue: No ]
  • Rate of acute and long-term toxicities [ Designated as safety issue: Yes ]
  • Patterns of disease recurrence [ Designated as safety issue: No ]
  • Radiation protocol compliance [ Designated as safety issue: No ]
  • Quality of life including psychosexual health [ Designated as safety issue: No ]
  • Rate of complete and partial metabolic response on a PET scan performed 4 - 6 months after completion of chemoradiation treatment [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To determine the progression-free survival rates. II. To determine acute and long-term toxicities. III. To determine patterns of disease recurrence. IV. To determine the association between radiation protocol compliance and outcomes.

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

TERTIARY OBJECTIVES:

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

II. 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), International Federation of Gynecology and Obstetrics (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 intravenously (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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Cell Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Chemotherapeutic Agent Toxicity
  • Cognitive/Functional Effects
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • Sexuality and Reproductive Issues
  • Stage IB Cervical Cancer
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage IVA Cervical Cancer
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Drug: carboplatin
    Given IV
    Other Names:
    • Carboplat
    • CBDCA
    • JM-8
    • Paraplat
    • Paraplatin
  • Radiation: external beam radiation therapy
    Undergo external beam radiation therapy
    Other Name: EBRT
  • Radiation: brachytherapy
    Undergo brachytherapy
    Other Names:
    • low-LET implant therapy
    • radiation brachytherapy
    • therapy, low-LET implant
  • Other: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
  • Experimental: Arm I (cisplatin, radiation therapy, brachytherapy)
    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.
    Interventions:
    • Drug: cisplatin
    • Radiation: external beam radiation therapy
    • Radiation: brachytherapy
    • Other: quality-of-life assessment
  • Experimental: Arm II (cisplatin, radiation therapy, brachytherapy, chemo)
    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.
    Interventions:
    • Drug: cisplatin
    • Drug: paclitaxel
    • Drug: carboplatin
    • Radiation: external beam radiation therapy
    • Radiation: brachytherapy
    • Other: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
780
Not Provided
July 2018   (final data collection date for primary outcome measure)

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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
  • White blood cells (WBC) >= 3.0 x 10^9/L
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelet count >= 100 x 10^9/L
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN
  • Creatinine =< ULN (Common Toxicity Criteria [CTC] Grade 0) OR calculated creatinine clearance (Cockcroft-Gault Formula) >= 60 mL/min OR >= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance
  • Written informed consent

Exclusion Criteria:

  • Any previous pelvic radiotherapy
  • 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 computed tomography [CT])
  • FIGO 2008 stage IIIA disease
  • Patients assessed at presentation as requiring interstitial brachytherapy treatment
  • Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
  • Previous chemotherapy for this tumor
  • Evidence of distant metastases
  • Prior diagnosis of Crohn disease or ulcerative colitis
  • Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] v. 4)
  • Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy
  • 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
  • Patients who are pregnant or lactating
  • Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy
  • 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
  • Human immunodeficiency virus (HIV) positive
Female
18 Years and older
No
United States,   Canada,   Saudi Arabia
 
NCT01414608
ANZGOG-0902/GOG-0274/RTOG-1174, NCI-2011-02978, CDR0000706698, GOG-0274, RTOG-1174, ANZGOG-0902, ANZGOG-0902/GOG-0274/RTOG-1174, ANZGOG-0902-GOG-0274, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Kathleen Moore Gynecologic Oncology Group
Gynecologic Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP