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 |
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Recruitment Status :
Active, not recruiting
First Posted : July 20, 2009
Results First Posted : December 18, 2018
Last Update Posted : December 18, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Drug: Carboplatin Drug: Cisplatin Radiation: Internal Radiation Therapy Drug: Paclitaxel Other: Quality-of-Life Assessment Radiation: Radiation Therapy | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 813 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | June 29, 2009 |
| Actual Primary Completion Date : | March 9, 2017 |
| Estimated Study Completion Date : | December 14, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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Drug: Carboplatin
Given IV Drug: Paclitaxel Given IV Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942357
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| Principal Investigator: | Daniela Matei | NRG Oncology |
Documents provided by Gynecologic Oncology Group:
| Responsible Party: | Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00942357 History of Changes |
| Other Study ID Numbers: |
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 ) |
| First Posted: | July 20, 2009 Key Record Dates |
| Results First Posted: | December 18, 2018 |
| Last Update Posted: | December 18, 2018 |
| Last Verified: | August 2018 |
Additional relevant MeSH terms:
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Adenocarcinoma Uterine Neoplasms Cystadenocarcinoma, Serous Adenocarcinoma, Clear Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female |
Cystadenocarcinoma Neoplasms, Cystic, Mucinous, and Serous Paclitaxel Albumin-Bound Paclitaxel Cisplatin Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |