Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000369224
Ethics application status
Approved
Date submitted
6/11/2008
Date registered
27/05/2009
Date last updated
1/12/2020
Date data sharing statement initially provided
3/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised phase III trial comparing concurrent chemoradiation and adjuvant chemotherapy with pelvic radiation alone in high risk and advanced stage endometrial carcinoma: PORTEC-3
Scientific title
A phase III trial to establish overall survival and failure-free survival of patients with high risk and advanced stage endometrial carcinoma, treated after sugery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone.
Secondary ID [1] 744 0
International Standard Randomised Controlled Trial Number Register 14387080
Secondary ID [2] 745 0
ClinicalTrials.gov NCT00411138
Universal Trial Number (UTN)
Trial acronym
PORTEC-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial carcinoma 3947 0
Condition category
Condition code
Cancer 4142 4142 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions, 5 fractions a week; radiotherapy treatment time should be kept within 6 weeks) with concurrent chemotherapy (2 cycles (21 day cycles) of intravenous cisplatin 50mg/m2 on day 1 of each cycle) followed by adjuvant chemotherapy (4 cycles (21 day cycles) of intravenous carboplatin AUC 5 and paclitaxel 175mg/m2 on day 1 of each cycle). Treatment time for the experimental arm is approximately 5 months, dependent on treatment delays. Follow-up will end at 10 years post-randomisation.
Intervention code [1] 3662 0
Treatment: Drugs
Intervention code [2] 3663 0
Treatment: Other
Comparator / control treatment
External beam pelvic radiotherapy (48.6 Gy in 1.8 Gy fractions, 5 fractions a week). Treatment time for the control arm should be kept within 6 weeks. Follow-up will end at 10 years post-randomisation.
Control group
Active

Outcomes
Primary outcome [1] 5032 0
Five year overall survival
Timepoint [1] 5032 0
Five years after randomisation
Primary outcome [2] 5033 0
Five year failure-free survival.
Failure is defined as relapse or death due to endometrial cancer or due to treatment complications.
Timepoint [2] 5033 0
Five years after randomisation
Secondary outcome [1] 8479 0
Quality of life. This will be assessed through Quality of Life questionnaires completed by study patients.
Timepoint [1] 8479 0
At baseline, completion of radiotherapy, 6, 12, 18, 24, 36 and 60 months
Secondary outcome [2] 8480 0
Severe treatment-related morbidity. This will be assessed by obtaining a detailed history. Toxicities will be reported according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Timepoint [2] 8480 0
Baseline, completion of radiotherapy, during each chemotherapy cycle (for experimental arm), 6 monthly until 5th year
Secondary outcome [3] 8481 0
Five year rates of vaginal, pelvic and distant relapse. This will be assessed through physical and pelvic exams and chest radiographs. Biopsies and computed tomography (CT) or magnetic resonance imaging (MRI) scans will be done on indication.
Timepoint [3] 8481 0
Five years after randomisation

Eligibility
Key inclusion criteria
1. Histologically confirmed endometrial carcinoma, with one of the following postoperative International Federation of Gynecology and Obstetrics (FIGO) stages and grade:
a. Stage IB grade 3 with documented Lymphatic Vascular Space Invasion (LVSI)
b. Stage 1C grade 3
c. Stage II grade 3
d. Stage IIIA or IIIC (IIIA based on peritoneal cytology alone is only eligible if grade 3)
e. Stage IB or IC, stage II or stage III with serous or clear cell histology
2. World Health Organisation (WHO) performance status zero to two
3. White Blood Cells (WBC) greater than or equal to 3.0 x 10^9/L
4. Platelets greater than or equal to 100 x 10^9/L
5. Bilirubin less than or equal to 1.5 x Upper Normalised Limit (UNL)
6. Aspartate Aminotransferase (ASAT)/Alanine Aminotreansferase (ALAT) less than or equal to 2.5 x UNL
7. Written informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous malignancy, except for basal cell carcinoma of the skin, less than ten years
2. Previous pelvic radiotherapy
3. Hormonal therapy or chemotherapy for this tumor
4. Macroscopic stage IIB for which Wertheim type hysterectomy
5. Prior diagnosis of Crohn's disease or ulcerative colitis
6. Residual macroscopic tumor after surgery
7. Creatinine clearance less than or equal to 60 ml/min (calculated according to Cockroft) or less than or equal to 50 ml/min (EthyleneDiamineTetraacetic Acid [EDTA] clearance, or measured creatinine clearance)
8. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
9. Peripheral Neuropathy more than or equal to grade two

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2006
Actual
7/11/2008
Date of last participant enrolment
Anticipated
Actual
20/12/2013
Date of last data collection
Anticipated
20/12/2023
Actual
Sample size
Target
680
Accrual to date
Final
686
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,TAS
Recruitment outside Australia
Country [1] 1354 0
New Zealand
State/province [1] 1354 0
Country [2] 1355 0
Netherlands
State/province [2] 1355 0
Country [3] 1356 0
United Kingdom
State/province [3] 1356 0
Country [4] 1357 0
Canada
State/province [4] 1357 0
Country [5] 1358 0
Italy
State/province [5] 1358 0
Country [6] 1359 0
France
State/province [6] 1359 0

Funding & Sponsors
Funding source category [1] 4122 0
Government body
Name [1] 4122 0
National Health and Medical Research Council
Country [1] 4122 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 3710 0
None
Name [1] 3710 0
Address [1] 3710 0
Country [1] 3710 0
Other collaborator category [1] 465 0
Other Collaborative groups
Name [1] 465 0
Dutch Cooperative Gynecologic Oncology Group
Address [1] 465 0
Integraal Kankercentrum West (IKW) trial Office
PO Box 9600
2300 RC Leiden
Country [1] 465 0
Netherlands
Other collaborator category [2] 466 0
Other Collaborative groups
Name [2] 466 0
UK National Cancer Research Institute
Address [2] 466 0
90 Tottenham Court Road
London W1T 4TJ
Country [2] 466 0
United Kingdom
Other collaborator category [3] 467 0
Other Collaborative groups
Name [3] 467 0
National Cancer Institute of Canada Clinical Trials Group
Address [3] 467 0
Queens University, 10 Stuart Street
Kingston, Ontario
K7L 3N6
Country [3] 467 0
Canada
Other collaborator category [4] 468 0
Other Collaborative groups
Name [4] 468 0
Italian MaNGO group
Address [4] 468 0
Simona Stupia, Dipartimento di Oncologia
Istituto di Ricerche Farmacologiche "Mario Negri"
Via Giuseppe La Masa, 19
20156 Milano
Country [4] 468 0
Italy
Other collaborator category [5] 251736 0
Other Collaborative groups
Name [5] 251736 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address [5] 251736 0
Level 4
Medical Foundation Building
92-94 Parramatta Road
CAMPERDOWN, NSW 2050
Country [5] 251736 0
Australia
Other collaborator category [6] 251737 0
Other Collaborative groups
Name [6] 251737 0
Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC)
Address [6] 251737 0
101 rue de Tolbiac
75654 Paris Cedex 13
Country [6] 251737 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6194 0
NSW Cancer Institute Clinical Research Ethics Committee
Ethics committee address [1] 6194 0
Ethics committee country [1] 6194 0
Australia
Date submitted for ethics approval [1] 6194 0
03/10/2007
Approval date [1] 6194 0
08/01/2008
Ethics approval number [1] 6194 0
2007C/10/026

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

Contacts
Principal investigator
Name 29106 0
A/Prof Linda Mileshkin
Address 29106 0
Peter MacCallum Cancer Centre
305 Grattan Street Melbourne VIC 3000
Country 29106 0
Australia
Phone 29106 0
+61 3 9656 1111
Fax 29106 0
Email 29106 0
[email protected]
Contact person for public queries
Name 12263 0
PORTEC-3 Trial Coordinator
Address 12263 0
NHMRC Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country 12263 0
Australia
Phone 12263 0
+61 2 9562 5000
Fax 12263 0
+61 2 9565 1863
Email 12263 0
[email protected]
Contact person for scientific queries
Name 3191 0
Linda Mileshkin
Address 3191 0
Peter MacCallum Cancer Centre
305 Grattan Street Melbourne VIC 3000
Country 3191 0
Australia
Phone 3191 0
+61 3 9656 1111
Fax 3191 0
+61 3 96561408
Email 3191 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.