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Trial record 1 of 1 for:    gog-0263
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Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01101451
Recruitment Status : Recruiting
First Posted : April 12, 2010
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE April 9, 2010
First Posted Date  ICMJE April 12, 2010
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE April 12, 2010
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
Recurrence-free survival (RFS) [ Time Frame: From protocol registration to date of first documented recurrence, death or date of last contact, assessed up to 11 years ]
Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test (alpha=0.05) will be used to compare RFS between treatment arms.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
Recurrence-free survival
Change History Complete list of historical versions of study NCT01101451 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • Overall survival (OS) [ Time Frame: From entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol, assessed up to 11 years ]
    Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test (alpha=0.05) will be used to compare OS between treatment arms.
  • Local control [ Time Frame: Up to 11 years ]
    Assessed with Exact Logistic Regression adjusted known prognostic factors.
  • Site(s) of recurrence [ Time Frame: Up to 11 years ]
    The site(s) of first disease recurrence will be classified as: pelvic-only, extra-pelvic-only or pelvic-and-extra-pelvic and tabulated by treatment group. The test of the hypothesis that the probability of local failure is independent of randomized treatment will be assessed with exact logistic regression adjusted know prognostic factors.
  • Incidence of adverse events graded according to the active version of Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 5 years ]
    In addition to displaying frequency of adverse events for each grade category, significance of observed differences between treatment arms within each category will be analyzed using Fishers? exact test.
  • Patient risk-benefit [ Time Frame: Up to 11 years ]
  • Treatment compliance [ Time Frame: Up to 11 years ]
    Assessed by the number of cycles and amount of chemoradiotherapy administered, treatment span, incidence and duration of treatment delays, reason for delays, and reason why off study therapy.
  • Quality of life, assessed using the Functional Assessment of Cancer Therapy (FACT)-Cervix, FACT-Gynecologic Oncology Group (GOG)/neurotoxicity 4 subscale, and the Brief Pain Inventory (BPI) [ Time Frame: Up to 9 months following the first day of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
  • Overall survival
  • Local control
  • Frequence and severity of adverse events as assessed by NCI CTCAE active version
  • Treatment compliance
  • Quality of life
  • Smoking history: prevalence of active smoking and extent of nicotine dependence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
Official Title  ICMJE Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)
Brief Summary This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy.

SECONDARY OBJECTIVES:

I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.

II. To assess differences (across treatment arms) in incidence and severity of therapy-attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE).

III. To provide assessment of patient risk version (vs) benefit (positive study only).

IV. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events).

TERTIARY OBJECTIVES:

I. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone.

II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.

ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • Stage I Cervical Cancer AJCC v6 and v7
  • Stage IA Cervical Cancer AJCC v6 and v7
  • Stage IB Cervical Cancer AJCC v6 and v7
  • Stage IIA Cervical Cancer AJCC v7
Intervention  ICMJE
  • Drug: Cisplatin
    Given IV
    Other Names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone's Chloride
    • Peyrone's Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Radiation: External Beam Radiation Therapy
    Undergo radiotherapy
    Other Names:
    • Definitive Radiation Therapy
    • EBRT
    • External Beam Radiotherapy
    • External Beam RT
    • external radiation
    • External Radiation Therapy
    • external-beam radiation
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo radiotherapy
    Other Names:
    • IMRT
    • Intensity Modulated RT
    • Intensity-Modulated Radiotherapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Active Comparator: Arm I (EBRT, IMRT)
    Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
    Interventions:
    • Radiation: External Beam Radiation Therapy
    • Radiation: Intensity-Modulated Radiation Therapy
    • Other: Laboratory Biomarker Analysis
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Experimental: Arm II (cisplatin, EBRT, IMRT)
    Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Cisplatin
    • Radiation: External Beam Radiation Therapy
    • Radiation: Intensity-Modulated Radiation Therapy
    • Other: Laboratory Biomarker Analysis
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Kim H, Park W, Kim YS, Kim YJ. Chemoradiotherapy is not superior to radiotherapy alone after radical surgery for cervical cancer patients with intermediate-risk factor. J Gynecol Oncol. 2019 Nov 21. doi: 10.3802/jgo.2020.31.e35. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
360
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2010)
480
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
  • Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):

    • Positive capillary-lymphovascular space involvement and one of the following:

      • Deep third penetration
      • Middle third penetration, clinical tumor >= 2 cm
      • Superficial third penetration, clinical tumor >= 5 cm
    • Negative capillary-lymphatic space involvement

      • Middle or deep third penetration, clinical tumor >= 4 cm
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Platelets >= 100,000/mcl
  • Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60 mL/min
  • Bilirubin =< 1.5 x normal
  • Alkaline phosphate =< 3 x normal
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal
  • Gynecologic Oncology Group (GOG) performance status 0, 1, 2
  • Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
  • Patients who have met the pre-entry requirements
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

  • Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
  • Patients with septicemia or severe infection
  • Patients with intestinal obstruction or gastrointestinal bleeding
  • Patients with postoperative fistula
  • Patients with cervix cancer who have received any previous radiation or chemotherapy
  • Patients whose circumstances do not permit completion of the study or the required follow-up
  • Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
  • Patients with GOG performance status of 3 or 4
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01101451
Other Study ID Numbers  ICMJE GOG-0263
NCI-2011-02037 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0263
CDR0000670125
GOG-0263 ( Other Identifier: NRG Oncology )
GOG-0263 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sang Y Ryu NRG Oncology
PRS Account Gynecologic Oncology Group
Verification Date March 2019

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