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Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00942357
Recruitment Status : Active, not recruiting
First Posted : July 20, 2009
Results First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE July 17, 2009
First Posted Date  ICMJE July 20, 2009
Results First Submitted Date August 23, 2018
Results First Posted Date December 18, 2018
Last Update Posted Date December 18, 2018
Actual Study Start Date  ICMJE June 29, 2009
Actual Primary Completion Date March 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
Number of Participants With Recurrence, Progression or Death [ Time Frame: Disease was to be assessed at baseline, end of treatment and every 6 months for two years, and annually up to 5 years. ]
Number of participants enrolled with recurrence or progression of disease or death up to date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2009)
Recurrence-free survival
Change History Complete list of historical versions of study NCT00942357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Number of Participants With Acute Adverse Effects as Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version (CTCAE) Version 3.0 [ Time Frame: Assessed throughout the treatment period and for 21-30 days after discontinuation of treatment ]
    The maximum grade of all treatment emergent adverse events without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.
  • Number of Participants With Late Adverse Events as Graded by the NCI CTCAE Version 3.0 [ Time Frame: Assessed every 6 months for 3 years ]
    The maximum grade of Adverse events reported during follow-up until progression of disease, a change of therapy or otherwise off study for a maximum of 3 years without regard to attribution. General guidelines for severity of adverse events are as follows: Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening and Grade 5 is death.
  • Overall Survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 8 years ]
    Independence between the two endpoints, RFS and survival, and randomized treatment will be assessed with a stratified logrank test for an intent-to-treat analysis of eligible patients.
  • Patient-reported Peripheral Neuropathy Symptoms [ Time Frame: Prior to study treatment (baseline), Arm 1: 1 week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatement, 70 weeks post the starting of study treatment ]
    Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less peripheral neuropathy symptoms.
  • Patient-reported Quality of Life (QOL) [ Time Frame: Prior to study treatment (baseline), Arm 1: 1 Week post completion of radiation therapy, Arm 2: Prior to cycle 3 (6 weeks post starting of study treatment), 18 weeks post the starting of study treatment, 70 weeks post the starting of study treatment ]
    Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). It is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-En TOI score is calculated as the sum of the subscale scores, ranges are 0-120 with a large score suggesting a better QOL.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2009)
  • Overall Survival
  • Cumulative incidence of local recurrence
  • Cumulative incidence of distant metastases
  • Acute and late adverse effects as measured by NCI CTCAE v3.0
  • Patient-reported quality of life
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
Official Title  ICMJE A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
Brief Summary This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I-IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.
Detailed Description

PRIMARY OBJECTIVES:

I. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I or II serous (uterine papillary serous carcinoma [UPSC]) or clear cell endometrial carcinoma and positive cytology.

SECONDARY OBJECTIVES:

I. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (i.e., increases survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with FIGO 2009 stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.

II. To compare the regimens with respect to acute and late adverse effects of therapy.

III. To determine the impact of patient-reported quality of life during and following treatment for up to 1 year with the two treatment regimens.

TERTIARY OBJECTIVES:

I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and whole blood specimens for future research.

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

ARM I: Patients receive cisplatin intravenously (IV) on days 1 and 29. Patients also undergo radiation therapy once daily (QD), 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 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 Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Stage IA Uterine Corpus Cancer
  • Stage IB Uterine Corpus Cancer
  • Stage II Uterine Corpus Cancer
  • Stage IIIA Uterine Corpus Cancer
  • Stage IIIB Uterine Corpus Cancer
  • Stage IIIC Uterine Corpus Cancer
  • Stage IVA Uterine Corpus Cancer
Intervention  ICMJE
  • Drug: Carboplatin
    Given IV
  • Drug: Cisplatin
    Given IV
  • Radiation: Internal Radiation Therapy
    Undergo brachytherapy
  • Drug: Paclitaxel
    Given IV
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Radiation: Radiation Therapy
    Undergo radiation therapy
Study Arms
  • Experimental: Arm I (cisplatin, radiation therapy, paclitaxel, carboplatin)
    Patients receive cisplatin IV on days 1 and 29. Patients also undergo radiation therapy QD, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Radiation: Internal Radiation Therapy
    • Drug: Paclitaxel
    • Other: Quality-of-Life Assessment
    • Radiation: Radiation Therapy
  • Active Comparator: Arm II (paclitaxel and carboplatin)
    Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Other: Quality-of-Life Assessment
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 17, 2018)
813
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2009)
804
Estimated Study Completion Date December 14, 2020
Actual Primary Completion Date March 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma

    • Surgical stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
    • Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
  • Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology
  • Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional
  • Patients with a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
  • White blood cell (WBC) >= 3,000/mcl
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Platelet count >= 100,000/mcl
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN)
  • Alkaline phosphatase =< 2.5 times ULN
  • Bilirubin =< 1.5 times ULN
  • Creatinine =< institutional ULN
  • Patients who have met the pre-entry requirements; testing values/results must meet eligibility criteria
  • Patients who have signed an approved informed consent and authorization permitting release of personal health information
  • Entry into the study is limited to no more than 8 weeks from the date of surgery

Exclusion Criteria:

  • Patients with carcinosarcoma
  • Patients with recurrent endometrial cancer
  • Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension
  • Patients who have had pelvic or abdominal radiation therapy
  • Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
  • Patients with an estimated survival of less than three months
  • Patients with FIGO 2009 stage IVB endometrial cancer
  • Patients with parenchymal liver metastases
  • Patients who have received prior chemotherapy for endometrial cancer
  • Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00942357
Other Study ID Numbers  ICMJE GOG-0258
NCI-2011-01951 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000649079
GOG-0258 ( Other Identifier: NRG Oncology )
GOG-0258 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Daniela Matei NRG Oncology
PRS Account Gynecologic Oncology Group
Verification Date August 2018

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