Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000167561
Ethics application status
Approved
Date submitted
1/05/2006
Date registered
11/05/2006
Date last updated
28/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-centre randomised trial of standard or higher targets for transfusion during chemo-radiation of cervix cancer.
Scientific title
A phase III feasibility study to evaluate the difference in average weekly haemoglobin concentrations between experimental and control groups and the impact of red cell concentrate transfusion of maintaining haemoglobin levels above 120g/l versus above 100g/l in anaemic patients with carcinoma of the cervix receiving concurrent cisplatin and radiation therapy.
Secondary ID [1] 288443 0
Nil
Universal Trial Number (UTN)
Trial acronym
HOSTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervix Cancer 1140 0
Condition category
Condition code
Cancer 1220 1220 0 0
Cervical (Cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive red cell concentrate transfusion to maintain their haemoglobin at pre-specified levels. Experimental Group From 120g/l Hb to 130g/l Hb. All patients receive external beam pelvic radiation with concurrent weekly cisplatin 40mg/m2 followed by intracavity radiation. External pelvic radiation +/- intracavity radiation with concomitant weekly cisplatin 40mg/m2 delivered intravenously on days 1,8,15,22,29 and once during parametrial boost (if given). Ideally all treatment should be completed within 8 weeks.
Intervention code [1] 972 0
None
Comparator / control treatment
Control Group From 100g/l Hb to 110g/l Hb.
Control group
Dose comparison

Outcomes
Primary outcome [1] 1655 0
Difference in average weekly haemoglobin concentrations between experimental and control groups.
Timepoint [1] 1655 0
Measured after each patient finishes treatment i.e. after 8 weeks, however final analysis of the primary outcome will occur after the required 100th patient has completed treatment.
Secondary outcome [1] 2950 0
The following will be analysed after accrual of 100 patients to assess the feasibility of the trial: rate of accrual;proportion of eligible women actually randomised and compliance with randomised treatment allocation.
Timepoint [1] 2950 0
This analysis is due to take place two years after recruitment start date (approx May 2008).

Eligibility
Key inclusion criteria
1.Primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO Stage IB2 (equal to or greater than 4 cm diameter), II, III-B or IV-A;2.Haemoglobin level at randomization less than or equal to 125 g/l;3.No radiographic or pathologic evidence of para-aortic lymphadenopathy;4.Suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation;5.Adequate bone marrow function: ANC equal to or greater than 1.5 x 10 to the power of 9 /L; platelets equal to or greater than 100 x 10to the power of 9 /L;6.Adequate renal function with serum creatinine lesss than or equal to 1.5 times the institutional upper limit of normal;7.Approved informed consent;8.Geographically accessible and suitable for long-term follow-up.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients who have not been or cannot be adequately clinically staged;2.Patients with cancers of the uterine cervix other than squamous cell,adenosquamous, or adenocarcinoma;3.Patients with lower one-third vaginal involvement;4.Patients with disease outside the pelvis or with known intraperitoneal disease;5.Patients who for any reason have had previously been treated with pelvic radiation or have any contraindication to pelvic radiotherapy (e.g. inflammatory bowel disease, pregnancy);6.Patients who have had a previous or concomitant invasive cancer other than basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;7.Patients who have medical contraindications to chemotherapy, in particular cisplatin;8.Patients who have had a previous hysterectomy or carcinoma of the cervical stump; 9.Patients with a medical or psychosocial problem which, in the investigators opinion, would interfere with treatment or follow-up.

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)
Patients will be centrally randomised at the ANZGOG Coordinating Centre by fax.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation stratified on FIGO Stage, baseline haemoglobin level, type of brachytherapy used, whether para-aortic lymph node sampling has been performed and institution.
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/05/2006
Actual
5/07/2006
Date of last participant enrolment
Anticipated
Actual
20/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1331 0
Government body
Name [1] 1331 0
NHMRC Program Grant Seed Funding
Country [1] 1331 0
Australia
Funding source category [2] 1332 0
University
Name [2] 1332 0
National Taiwan University Hospital
Country [2] 1332 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Investigator initiated trial (name of investigator is Dr Michelle Grogan) coordinated by the University of Sydney.
Address
University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 1175 0
None
Name [1] 1175 0
Nil
Address [1] 1175 0
Country [1] 1175 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2679 0
University of Sydney
Ethics committee address [1] 2679 0
Ethics committee country [1] 2679 0
Australia
Date submitted for ethics approval [1] 2679 0
Approval date [1] 2679 0
31/05/2005
Ethics approval number [1] 2679 0
05-2005/5/7786
Ethics committee name [2] 2680 0
Prince Of Wales
Ethics committee address [2] 2680 0
Ethics committee country [2] 2680 0
Australia
Date submitted for ethics approval [2] 2680 0
Approval date [2] 2680 0
Ethics approval number [2] 2680 0
06/024

Summary
Brief summary
To assess whether raising haemoglobin (red blood cells that carry oxygen throughout the body) levels during treatment can improve patient quality of life and treatment effectiveness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35361 0
Dr Michelle Grogan
Address 35361 0
Royal Brisbane and Womens Hospital
Butterfield St & Bowen Bridge Rd,
Herston QLD 4006
Country 35361 0
Australia
Phone 35361 0
+61 7 3636 8111
Fax 35361 0
Email 35361 0
[email protected]
Contact person for public queries
Name 10161 0
Dr ANZGOG Trials
Address 10161 0
University of Sydney
NHMRC CTC
Locked Bag 77
Camperdown
NSW 2095
Country 10161 0
Australia
Phone 10161 0
02 9562 5000
Fax 10161 0
02 9562 5094
Email 10161 0
[email protected]
Contact person for scientific queries
Name 1089 0
Dr Dr Michelle Grogan
Address 1089 0
Royal Brisbane and Women's Hospital
Butterfield St & Bowen Bridge Rd, Herston QLD 4006
Country 1089 0
Australia
Phone 1089 0
61 7 3636 8111
Fax 1089 0
Email 1089 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.