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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00147680




Registration number
NCT00147680
Ethics application status
Date submitted
6/09/2005
Date registered
7/09/2005
Date last updated
2/02/2012

Titles & IDs
Public title
Uterine Papillary Serous Cancer (UPSC) Trial
Scientific title
Prospective, Non-randomised Phase 2 Clinical Trial of Carboplatin Plus Paclitaxel With Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer
Secondary ID [1] 0 0
UPSC - 001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Paclitaxel, Carboplatin

Treatment: Drugs: Paclitaxel, Carboplatin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and efficacy of the combination of paclitaxel and carboplatin plus/minus (+/-) pelvic radiotherapy in the treatment of UPSC
Timepoint [1] 0 0
Primary outcome [2] 0 0
To observe the patterns of recurrence following the administration of the combination of paclitaxel and carboplatin +/- pelvic radiotherapy in the treatment of UPSC
Timepoint [2] 0 0
Secondary outcome [1] 0 0
To assess the quality of life (QOL), overall survival and disease free survival
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
QCGC, Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Mater Adult Public Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Centre for Gynaecological Cancer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00147680
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair
Address 0 0
QCGC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications