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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00942357
First received: July 17, 2009
Last updated: March 7, 2014
Last verified: March 2014

July 17, 2009
March 7, 2014
June 2009
February 2016   (final data collection date for primary outcome measure)
Recurrence-free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
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.
Recurrence-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00942357 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.
  • Cumulative incidence of local recurrence [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Cumulative incidence of distant metastases [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Acute and late adverse effects as measured by NCI CTCAE v3.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    The maximum grade over the entire course of therapy for any individual effect will be used as a summary of acute toxicity. The Kruskal-Wallis test corrected for ties will be used to compare the maximum grade of acute adverse effects of therapy by treatment arm. A significance level of 0.01 will be used for each tested AE term or category. No correction for multiple testing will be employed, since it is very important to identify moderate increases in the severity of toxicity at the risk of increasing the Type I error.
  • Patient-reported quality of life measured using FACT-G Physical Well-being (PWB) and Functional Well-being (FWB) subscales, FACT-En additional concerns subscale, FACT/GOG-NTX-4 subscale, and items C3 and C5 from the FACT-C [ Time Frame: Up to 1 year after completion of study treatment ] [ Designated as safety issue: No ]
    Linear mixed models adjusted for baseline score, age, and performance status at enrollment will be used to test the hypothesis of no difference in PWB+FWB scores and FACT-GOG/NTX-4 scores between assigned treatment arms in an intent-to-treat analysis of eligible patients. These models will account for the correlation among scores measured over time. The interaction between treatment and assessment time on QOL scores will be tested initially in each model.
  • Overall survival [ Designated as safety issue: No ]
  • Cumulative incidence of local recurrence [ Designated as safety issue: No ]
  • Cumulative incidence of distant metastases [ Designated as safety issue: No ]
  • Acute and late adverse effects as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Patient-reported quality of life [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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, stage II, stage III, or stage 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 or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation 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.

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 Federation of Gynecology and Obstetrics (FIGO) 2009 Stage I or II serous (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: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) on days 1 and 29. Patients also undergo external-beam radiotherapy 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.

Patients complete quality-of-life questionnaires at baseline and periodically during study using the Functional Assessment of Cancer Therapy (FACT)-general (G) Physical and Functional Well-Being, FACT-Endometrial, FACT/Gynecologic Oncology Group (GOG) Neuropathy, and FACT-C (items C3 and C5).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Endometrial Clear Cell Carcinoma
  • Endometrial Papillary Serous Carcinoma
  • Stage I Endometrial Carcinoma
  • Stage II Endometrial Carcinoma
  • Stage III Endometrial Carcinoma
  • Stage IV Endometrial Carcinoma
  • 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: brachytherapy
    Undergo brachytherapy
    Other Names:
    • low-LET implant therapy
    • radiation brachytherapy
    • therapy, low-LET implant
  • Experimental: Arm I (cisplatin, brachytherapy, paclitaxel, carboplatin))
    Patients receive cisplatin IV on days 1 and 29. Patients also undergo external-beam radiotherapy once daily, 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: cisplatin
    • Drug: paclitaxel
    • Drug: carboplatin
    • Radiation: brachytherapy
  • Experimental: 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: paclitaxel
    • Drug: carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
804
Not Provided
February 2016   (final data collection date for primary outcome measure)

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 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 glutamic 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
Female
18 Years and older
No
United States,   Canada,   Korea, Republic of
 
NCT00942357
GOG-0258, NCI-2011-01951, CDR0000649079, GOG-0258, GOG-0258, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Daniela Matei Gynecologic Oncology Group
Gynecologic Oncology Group
March 2014

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