Trial record 1 of 1 for:    NCT01414608
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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
  Purpose

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.


Condition Intervention Phase
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
Drug: paclitaxel
Drug: carboplatin
Radiation: external beam radiation therapy
Radiation: brachytherapy
Other: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: At 5 years ] [ Designated as safety issue: No ]
    Described with Kaplan-Meier curves and unadjusted logrank tests.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 780
Study Start Date: January 2012
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
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 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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414608

  Show 150 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Kathleen Moore Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01414608     History of Changes
Other Study ID Numbers: 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
Study First Received: August 10, 2011
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Radiation Injuries
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Wounds and Injuries
Cisplatin
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 25, 2014