Uterine Cancer
Conditions
Keywords
Uterine Papillary Serous Carcinoma (UPSC)
Brief summary
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.
Detailed description
Trial Objectives: * To assess the safety and efficacy of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatment of UPSC. * To observe the patterns of recurrence following the administration of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatment of UPSC. * To assess the QOL, overall survival and disease free survival. Treatment Surgery: Total abdominal hysterectomy, bilateral salpingo-oophorectomy, +/- pelvic and aortic node sampling, omentectomy, peritoneal cytology. Chemotherapy: Chemotherapy commences at the surgeon's and the medical oncologist's discretion and the time between surgery and start of chemotherapy will be recorded. One treatment cycle consists of 3 weeks. Paclitaxel and Carboplatin will be administered as follows: Day 1: * Diphenhydramine 50 mg IV or po or phenergan 12.5 - 25 mg IV * Cimetidine 300 mg or ranitidine 50 mg IV * Dexamethasone 20 mg IV * Paclitaxel 175 mg/m2 * Carboplatin AUC 6 Day 22: Repeat the cycle. This is Day 1 of the second cycle. Day 43: Repeat the cycle. This is Day 1 of the third cycle. Day 64: Repeat the cycle. This is Day 1 of the fourth cycle. Day 85: After the fourth cycle of chemotherapy patients Patients with stage 4 disease will continue with chemotherapy for a total of 6 cycles. Patients with surgical stage 1b to 3c disease will receive whole pelvis external beam radiotherapy (50.4 Gy RD over 5 and a half weeks +/- paraaortic boost +/- vaginal vault brachytherapy boost). Radiotherapy will start 4 to 6 weeks after commencement of chemotherapy when the haematological count has recovered.
Interventions
Sponsors
Queensland Centre for Gynaecological Cancer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC | — |
| To observe the patterns of recurrence following the administration of the combination of paclitaxel and carboplatin +/- pelvic radiotherapy in the treatment of UPSC | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the quality of life (QOL), overall survival and disease free survival | — |
Countries
Australia
Outcome results
None listed