Trial · NCT00063999
Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
NCT00063999, Phase 3, Completed, GOG Foundation; results first posted 2018-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer. Trials, record NCT00063999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00063999
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
- NCT number
- NCT00063999
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,381 participants, actual
- Lead sponsor
- GOG Foundation
- Conditions
Recurrent Uterine Corpus Carcinoma, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7
- Interventions
- Carboplatin, Cisplatin, Doxorubicin Hydrochloride, Filgrastim, Laboratory Biomarker Analysis, Paclitaxel, Pegfilgrastim, Quality-of-Life Assessment
- First posted
- 2003-07-09
- Last updated
- 2021-10-19
- Results first posted
- 2018-04-23
- Limitations and caveats
Eligibility for this study was expanded from measurable, stage 3 or stage 4 or recurrent disease to include non-measurable, stage 4 or recurrent disease and then to include non-measurable stage 3 disease.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Alive at Time of Last Follow-up. | Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years. | The time alive in months from study entry to last contact or death. |
| Secondary | Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start | The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as 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 Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life). |
| Secondary | Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G | Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment | The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as 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 answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL. |
| Secondary | Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative) | Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years. | The time alive in months from study entry to last contact or death. |
| Secondary | Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection | Assessed throughout the treatment period and for 30 days after discontinuation of treatment. | Maximum grade of physician assessed neurotoxicity and infection |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Alive at Time of Last Follow-up. | Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years. | Eligible and treated patients. Data are reported from the second interim analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start | Eligible and evaluable and enrolled prior to 3/26/2006 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G | Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment | Eligible and evaluable and enrolled prior to 3/26/2006 | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative) | Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years. | Eligible patients with estrogen and progesterone receptor data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection | Assessed throughout the treatment period and for 30 days after discontinuation of treatment. | Eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Alive at Time of Last Follow-up. | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | Alive | 376 | Participants | |
| Number of Participants Alive at Time of Last Follow-up. | Arm II (Paclitaxel, Carboplatin) | Alive | 385 | Participants | |
| Number of Participants Alive at Time of Last Follow-up. | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | Dead | 271 | Participants | |
| Number of Participants Alive at Time of Last Follow-up. | Arm II (Paclitaxel, Carboplatin) | Dead | 280 | Participants | |
| Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Doxorubicin, Cisplatin, Paclitaxel | Baseline | 14.9 | Standard Error 0.15 | units on a scale |
| Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Paclitaxel, Carboplatin | Baseline | 14.9 | Standard Error 0.14 | units on a scale |
| Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Doxorubicin, Cisplatin, Paclitaxel | 6 Weeks | 13.5 | Standard Error 0.28 | units on a scale |
| Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Paclitaxel, Carboplatin | 6 Weeks | 11.3 | Standard Error 0.27 | units on a scale |
| Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Doxorubicin, Cisplatin, Paclitaxel | 15 Weeks | 11.1 | Standard Error 0.37 | units on a scale |
| Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) | Paclitaxel, Carboplatin | 15 Weeks | 11.2 | Standard Error 0.34 | units on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doxorubicin, Cisplatin, Paclitaxel | 692 | |
| Overall Study | STARTED | Paclitaxel, Carboplatin | 689 | |
| Overall Study | COMPLETED | Doxorubicin, Cisplatin, Paclitaxel | 647 | |
| Overall Study | COMPLETED | Paclitaxel, Carboplatin | 665 | |
| Overall Study | NOT COMPLETED | Doxorubicin, Cisplatin, Paclitaxel | 45 | |
| Overall Study | NOT COMPLETED | Paclitaxel, Carboplatin | 24 |
Source ClinicalTrials.gov
Adverse events246
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytes | Blood and lymphatic system disorders | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 418 | 647 | |
| other | Leukocytes | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin) | 556 | 665 | |
| other | Neutrophils/Granulocytes | Blood and lymphatic system disorders | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 402 | 647 | |
| other | Neutrophils/Granulocytes | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin) | 590 | 665 | |
| other | Platelets | Blood and lymphatic system disorders | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 244 | 647 | |
| other | Platelets | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin) | 172 | 665 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 445 | 647 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin) | 410 | 665 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 202 | 647 | |
| other | Hematologic-Other | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin) | 156 | 665 |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 271 | 647 |
| Total, all-cause mortality | Arm II (Paclitaxel, Carboplatin) | 280 | 665 |
| Total, other adverse events | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 631 | 647 |
| Total, other adverse events | Arm II (Paclitaxel, Carboplatin) | 657 | 665 |
| Total, serious adverse events | Arm I (Doxorubicin, Cisplatin, Paclitaxel) | 217 | 647 |
| Total, serious adverse events | Arm II (Paclitaxel, Carboplatin) | 156 | 665 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33078978 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) vs Arm II (Paclitaxel, Carboplatin): deaths from any cause | Trial comparisons |
| Arm I (Doxorubicin, Cisplatin, Paclitaxel) vs Arm II (Paclitaxel, Carboplatin): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00063999
GET https://conductscience.org/api/trials/v1/NCT00063999/results?page=2