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Trial registered on ANZCTR


Registration number
ACTRN12605000561684
Ethics application status
Approved
Date submitted
24/09/2005
Date registered
30/09/2005
Date last updated
30/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase II trial of adjuvant chemo-radiation followed by chemotherapy for patients with newly diagnosed endometrial carcinoma at high-risk of relapse
Scientific title
A phase II trial to evaluate the effect on progression-free survival of adjuvant chemo-radiation followed by chemotherapy with carboplatin and paclitaxel for patients with newly diagnosed endometrial carcinoma at high-risk of relapse
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial carcinoma 687 0
Condition category
Condition code
Cancer 761 761 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adjuvant chemo-radiation followed by chemotherapy. Patients will be treated with adjuvant pelvic radiotherapy plus concurrent Carboplatin chemotherapy, followed by 4 cycles of chemotherapy with Carboplatin plus Paclitaxel. The toal duration of the intervention is 24 weeks.
Intervention code [1] 673 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 965 0
Progression-free survival
Timepoint [1] 965 0
All patients will be followed and reported on for 5 years.
Secondary outcome [1] 1830 0
To determine time to local failure
Timepoint [1] 1830 0
Secondary outcome [2] 1831 0
Duration of local control
Timepoint [2] 1831 0
Secondary outcome [3] 1832 0
Overall survival
Timepoint [3] 1832 0
Secondary outcome [4] 1833 0
To document the acute and long-term toxicities of the adjuvant treatment as well as patterns of disease recurrence.
Timepoint [4] 1833 0

Eligibility
Key inclusion criteria
Patients must have newly diagnosed, histologically confirmed endometrial carcinoma, and have undergone a total abdominal hysterectomy and bilateral salpingo-oophorectomy with or without a dissection of pelvic and/or para-aortic nodes. It is also recommended that patients will have undergone an omentectomy and had peritoneal washings taken. In addition, patients must be either:A. Patients with documented involvement of pelvic and/or para-aortic nodes by histology (FIGO stage IIIc) or post-operative PET, CT or PET/CTORB. Patients who have not undergone a complete lymphadenectomy, who have negative sampled nodes or unknown nodal status and have high-risk disease as defined by:a) FIGO stage Ic or IIb with : aggressive non-endometroid histology (serous papillary or clear cell type comprising 10% of the endometrial tumour) ORb) FIGO stage IIb with : grade 3 histologyc) Any FIGO stage III disease excluding those defined as stage III only by positive peritoneal cytologyPatients must not have received any prior chemotherapy for another malignancy. Patients who have been treated for other malignancies must not have received prior pelvic or abdominal radiotherapy, and any prior radiotherapy must have been to less than 15% of the bone marrow bearing areasECOG performance status less than 2Life expectancy of greater than 6 months.Patients must have normal organ and marrow function as defined below:- absolute neutrophil count >1,500- platelets > 100,000- total bilirubin < 1.25 X upper limit of normal - AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal.- estimated GFR > 50 ml/minPatient has given written informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with other invasive malignancies, with the exception of treated non-melanoma skin cancer, in the last 5 yearsPatients receiving any other therapeutic investigational agents Patients who are receiving concurrent treatment with any other anti-cancer therapyPatients who have commenced any post-surgical anti-cancer treatment for endometrial cancerEvidence of distant metastasesHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin Symptomatic peripheral neuropathy greater than or equal to grade 2.Serious illness of medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase II multi-centre trial
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 842 0
Commercial sector/Industry
Name [1] 842 0
Bristol-Myers Squibb
Country [1] 842 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 709 0
None
Name [1] 709 0
Nil
Address [1] 709 0
Country [1] 709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2109 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2109 0
Ethics committee country [1] 2109 0
Australia
Date submitted for ethics approval [1] 2109 0
Approval date [1] 2109 0
Ethics approval number [1] 2109 0

Summary
Brief summary
This is a trial of follow-up (adjuvant) treatment with combined chemotherapy and radiation treatment followed by further chemotherapy for women who have undergone surgery for endometrial carcinoma but are thought to be at high-risk of developing relapse of the cancer
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35663 0
Address 35663 0
Country 35663 0
Phone 35663 0
Fax 35663 0
Email 35663 0
Contact person for public queries
Name 9862 0
Hannah O'Leary
Address 9862 0
Research Nurse
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 9862 0
Australia
Phone 9862 0
+61 3 96561111
Fax 9862 0
+61 3 96561408
Email 9862 0
[email protected]
Contact person for scientific queries
Name 790 0
Dr Linda Mileshkin
Address 790 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 790 0
Australia
Phone 790 0
+61 3 96561697
Fax 790 0
+61 3 96561408
Email 790 0
[email protected]

No information has been provided regarding IPD availability


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.