Trial reportGynecologic oncology2011
A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian carcinoma: a Gynecologic Oncology Group Study.
Trial report in Gynecologic oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003644 (A Randomized Phase III Trial of IV Carboplatin), which is not on this map. Cited by 28 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma
Who cites it
28 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Efficacy and Safety of Placebo During the Maintenance Therapy of Ovarian Cancer in Randomized Controlled Trials: A Systematic Review and Meta-analysis.Frontiers in oncology · 2022Pooled it
- Assessment of Progression-Free Survival as a Surrogate End Point of Overall Survival in First-Line Treatment of Ovarian Cancer: A Systematic Review and Meta-analysis.JAMA network open · 2020Pooled it
- Differences in presentation and survival of Asians compared to Caucasians with ovarian cancer: An NRG Oncology/GOG Ancillary study of 7914 patients.Gynecologic oncology · 2019Pooled it
- Adjuvant (post-surgery) chemotherapy for early stage epithelial ovarian cancer.The Cochrane database of systematic reviews · 2015Pooled it
- Maintenance chemotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2013Pooled it
- Adjuvant (post-surgery) chemotherapy for early stage epithelial ovarian cancer.The Cochrane database of systematic reviews · 2012Pooled it
- Optimal treatment of early-stage ovarian cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2014Trial
- Web-based symptom management for women with recurrent ovarian cancer: a pilot randomized controlled trial of the WRITE Symptoms intervention.Journal of pain and symptom management · 2014Trial
- Ocular toxicities associated with anticancer drug therapy in Asian patients: a literature review and practical management recommendations for non-ophthalmologic settings.International journal of clinical oncology · 2026Review
- Article
- Correlates of Taxane-Induced Neuropathy, an Electronic Health Record Based Observational Study.Cancers · 2023Article
- Maintenance therapy for long-term control of high-grade endometrial stromal sarcoma.BMJ case reports · 2022Article
- Impact of Value Frameworks on the Magnitude of Clinical Benefit: Evaluating a Decade of Randomized Trials for Systemic Therapy in Solid Malignancies.Current oncology (Toronto, Ont.) · 2021Article
- Introduction of rectosigmoid colectomy improves survival outcomes in early-stage ovarian cancer patients.International journal of clinical oncology · 2021Article
- Comparative efficacy of targeted maintenance therapy for newly diagnosed epithelial ovarian cancer: a network meta-analysis.Cancer management and research · 2019Article
- Survival benefit of patients with early-stage ovarian carcinoma treated with paclitaxel chemotherapeutic regimens.Journal of gynecologic oncology · 2018Article
- Clinical outcome and prognostic factors of patients with early-stage epithelial ovarian cancer.Oncotarget · 2017Article
- Morphologic and Molecular Characteristics of Mixed Epithelial Ovarian Cancers.The American journal of surgical pathology · 2015Article
- Re-visiting Hypersensitivity Reactions to Taxanes: A Comprehensive Review.Clinical reviews in allergy & immunology · 2015Review
- Metronomics: towards personalized chemotherapy?Nature reviews. Clinical oncology · 2014Review
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
objectiveTo compare the recurrence-free interval (RFI) and safety profile in patients with completely resected high-risk early-stage ovarian cancer treated with intravenous (IV) carboplatin and paclitaxel with or without maintenance low-dose paclitaxel for 24 weeks.
methodsEligibility was limited to patients with stage IA/B (grade 3 or clear cell), all IC or II epithelial ovarian cancer. All patients were to receive carboplatin AUC 6 and paclitaxel 175 mg/m² q3 weeks × 3 courses with random assignment to either observation or maintenance paclitaxel 40 mg/m²/week × 24 weeks. Recurrence required clinical or radiological evidence of new tumor.
resultsThere were 571 patients enrolled onto this study, of whom 29 were deemed ineligible due to inappropriate stage or pathology, leaving 542 patients. At least 3 cycles of treatment were administered to 524/542 (97%) of patients, and among those assigned to maintenance paclitaxel, 80% completed the regimen. The incidence of grade 2 or worse peripheral neuropathy (15.5% vs. 6%), infection/fever (19.9% vs. 8.7%), and dermatologic events (70.8% vs. 52.1%) was higher on the maintenance regimen (p<0.001). The cumulative probability of recurring within 5 years for the maintenance paclitaxel regimen is 20% vs. 23% for surveillance (hazard ratio 0.807; 95% CI: 0.565-1.15). The probability of surviving 5 years was 85.4% and 86.2%, respectively.
conclusionMaintenance paclitaxel at 40 mg/m²/week × 24 weeks added to standard dose AUC6 and paclitaxel 175 mg/m² × 3 doses provides no significant increase in RFI.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.