A multi-centre randomised trial of standard or higher targets for transfusion during chemo-radiation of cervix cancer.

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000167561

Acronym

HOSTT

Enrollment

Registered

2006-05-11

Start date

2006-07-05

Completion date

2008-11-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results