Clinical trial · Interventional
Uterine Papillary Serous Cancer (UPSC) Trial
Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will be an open, non-randomised, clinical phase 2 trial, which will involve 30 women diagnosed with uterine papillary serous cancer. The researchers will investigate the effect of four cycles of paclitaxel/carboplatin, followed by whole pelvic external beam radiotherapy to a standard pelvis field (50.4 Gy) with or without a para-aortic boost with respect to the safety and efficacy of treatment, and patterns of recurrence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel, Carboplatin | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC
- measure
- To observe the patterns of recurrence following the administration of the combination of paclitaxel and carboplatin +/- pelvic radiotherapy in the treatment of UPSC
Secondary outcomes (1)
- measure
- To assess the quality of life (QOL), overall survival and disease free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed UPSC at surgical stage 1b to 4 disease. The serous-papillary component of the specimen must be at least 30 percent. Patients with surgical stage 1a disease should not be enrolled. * Females aged \>= 18 years old. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. * Patients may not have received any prior chemotherapy regimens for UPSC. * Patients must have adequate bone marrow, renal, hepatic and neurologic function. * Patients must be informed of the investigational nature of the study and sign an informed consent form. * Patients with previous malignancy are eligible only if the patient has been disease-free for \>= 5 years. Exclusion Criteria: * Patients with pre-existing \>= grade 2 neurotoxicity. * Patients with uncontrolled hypertension, (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg) or uncontrolled cardiac arrhythmia or diabetes mellitus * Patients with a history of other malignancy within the last 5 years that could affect the diagnosis or assessment of UPSC. * Patients who have a history of serious cardiac disease that is not adequately controlled are not allowed. Patients with documented myocardial infarction within 6 months preceding study entry; congestive heart failure; unstable angina; a clinically significant pericardial effusion; or arrhythmias are also ineligible. * Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. * Serious medical or psychiatric illnesses that would prevent informed consent. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. * Patients with prior significant allergic reactions to drugs containing cremophor, such as cyclosporine, or vitamin K are not eligible. A significant reaction may be defined as, but is not limited to, the description of grade \>= 3 allergic reactions using the Common Toxicity Criteria (CTC). Patients with known hypersensitivity to paclitaxel, carboplatin or Cremophor EL. * Patients who have received prior whole pelvis radiotherapy. * Patients with uncontrolled pelvic inflammatory disease that would contraindicate pelvic radiotherapy. * Patients who are pregnant or breast-feeding. * Patients receiving other investigational therapy.
References
Publications (0)
Data not yet available