Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000125426
Ethics application status
Approved
Date submitted
15/01/2007
Date registered
12/02/2007
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Uterine Serous Papillary Cancer (UPSC) Trial
Scientific title
A Prospective, Non-Randomised Phase 2, Open Feasibility Study on the Effect of Carboplatin plus Paclitaxel with Sequential Radical Pelvic Radiotherapy for Uterine Serous Papillary Cancer with respect to Safety and Efficacy of Treatment and Patterns of Recurrence.
Secondary ID [1] 342 0
ClinicalTrials.gov: NCT00147680
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Papillary Serous Carcinoma 1617 0
Condition category
Condition code
Cancer 1725 1725 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: Paclitaxel, Carboplatin
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: Premedications* including:
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 175mg/m2
Carboplatin Area Under Curve (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 with stage 4 disease will continue with chemotherapy to a total of 6 cycles
Patients with surgical stage 1b to 3c disease will receive whole pelvis external beam radiotherapy (50.4 Gy Recommended Dose (RD) over 5 and a half weeks +/- paraaortic boost +/- vaginal vault brachytherapy boost). Radiotherapy will start 4 weeks after commencement of chemotherapy and when the haematological count has recovered

*A patient's premedications can be reduced to diphenhydramine 25 mg/ phenergan 6.25mg and dexamethasone 10 mg or lower after the observation that the patient did not have any allergic reaction to the first and second doses of Paclitaxel.
Intervention code [1] 1332 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Historical

Outcomes
Primary outcome [1] 2396 0
To assess the safety and efficacy of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatmement of UPSC.
Timepoint [1] 2396 0
Before each cycle of chemotherapy, a physical examination, vital signs, performance status, a FBC and a serum biochemistry will be performed.
During radiotherapy evaluation of toxicity is done on a weekly basis.
Following completion of therapy, patients will be followed for at least five (5) years) at 3-monthly intervals for the first three (3) years and half-yearly thereafter.
To observe the patterns of recurrence following the administration of the combination of Paclitaxel and Carboplatin +/- pelvic radiotherapy in the treatment of UPSC
Secondary outcome [1] 4160 0
To assess the Qualtiy of Life (QOL), overall survival and disease free survival.
Timepoint [1] 4160 0
QOL to be completed at screening (after surgery), at every cycle of chemotherapy (4 to 6 cycles dependant on stage of disease) pre X-ray therapy (XRT) and weekly during XRT until the end of a 5.5 week treatment program. Overall survival will be defined as observed length of life from entry onto the protocol to death, or for living patients, date of last contact. Disease free survival will be defined as the date from entry onto the protocol to the date of clinical or radiological evidence of progressive disease
Secondary outcome [2] 4161 0
Before each cycle of chemotherapy, a physical examination, vital signs, performance status, a Full Blood Count (FBC) and a serum biochemistry will be performed.
Timepoint [2] 4161 0
Before each cycle of chemotherapy up until the 4th or 6th cycle dependant on the stage of disease
Secondary outcome [3] 4162 0
During radiotherapy evaluation of toxicity is done on a weekly basis.
Timepoint [3] 4162 0
during X-ray therapy (XRT) each week for the period of treatment (5.5 weeks)
Secondary outcome [4] 4163 0
Following completion of therapy, patients will be followed for at least five (5) years) at 3-monthly intervals for the first three (3) years and half-yearly thereafter.
Timepoint [4] 4163 0
follow up for at least 5 years at 3-monthly intervals for the first three years and half-yearly thereafter

Eligibility
Key inclusion criteria
Patients with histologically confirmed Uterine Papillary Serous Carcinoma (UPSC) at surgical stage 1b to 4 disease. The serous-papillary component of the specimen must be at least 30 per cent. Patinets with surgical stage 1a disease should not be enrolled. Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2. 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
80 Years
Sex
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 proceeding 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. 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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2004
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
29/02/2008
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1874 0
Commercial sector/Industry
Name [1] 1874 0
Bristol - Myers Squibb Pharmaceuticals
Country [1] 1874 0
Australia
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Level 6 Ned Hanlon Building
Butterfield St
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 1689 0
None
Name [1] 1689 0
n/a
Address [1] 1689 0
Country [1] 1689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3493 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 3493 0
Ethics committee country [1] 3493 0
Australia
Date submitted for ethics approval [1] 3493 0
Approval date [1] 3493 0
22/12/2003
Ethics approval number [1] 3493 0
2003/200
Ethics committee name [2] 3494 0
Mater Health Services
Ethics committee address [2] 3494 0
Ethics committee country [2] 3494 0
Australia
Date submitted for ethics approval [2] 3494 0
Approval date [2] 3494 0
16/11/2005
Ethics approval number [2] 3494 0
906A
Ethics committee name [3] 3495 0
Wesley Private Hospital
Ethics committee address [3] 3495 0
Ethics committee country [3] 3495 0
Australia
Date submitted for ethics approval [3] 3495 0
Approval date [3] 3495 0
23/09/2004
Ethics approval number [3] 3495 0
2004/35
Ethics committee name [4] 3496 0
Prince of Wales Hospital Sydney
Ethics committee address [4] 3496 0
Ethics committee country [4] 3496 0
Australia
Date submitted for ethics approval [4] 3496 0
Approval date [4] 3496 0
05/04/2005
Ethics approval number [4] 3496 0
05/049
Ethics committee name [5] 3497 0
Greenslopes Private Hospital
Ethics committee address [5] 3497 0
Ethics committee country [5] 3497 0
Australia
Date submitted for ethics approval [5] 3497 0
Approval date [5] 3497 0
14/09/2004
Ethics approval number [5] 3497 0
04/01
Ethics committee name [6] 3498 0
Peter MacCallum Cancer Centre East Melbourne
Ethics committee address [6] 3498 0
Ethics committee country [6] 3498 0
Australia
Date submitted for ethics approval [6] 3498 0
Approval date [6] 3498 0
14/02/2006
Ethics approval number [6] 3498 0
05/40
Ethics committee name [7] 3499 0
Christchurch Hospital - Canterbury Ethics Committee
Ethics committee address [7] 3499 0
Ethics committee country [7] 3499 0
New Zealand
Date submitted for ethics approval [7] 3499 0
Approval date [7] 3499 0
Ethics approval number [7] 3499 0
CTB/04/09/151

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27939 0
Address 27939 0
Country 27939 0
Phone 27939 0
Fax 27939 0
Email 27939 0
Contact person for public queries
Name 10521 0
Dan Jackson
Address 10521 0
Queensland Centre for Gynaecological Cancer
Teaching and Research Level 6
Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston QLD 4026
Country 10521 0
Australia
Phone 10521 0
+61 7 36368522
Fax 10521 0
+61 7 36361721
Email 10521 0
[email protected]
Contact person for scientific queries
Name 1449 0
Associate Professor Andreas Obermair
Address 1449 0
Queensland Centre for Gynaecological Cancer
Teaching and Research Level 6
Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston QLD 4026
Country 1449 0
Australia
Phone 1449 0
+61 7 36361722
Fax 1449 0
+61 7 36361721
Email 1449 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.