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

Phase 3

• Conditions: Cervix Cancer; Cancer - Cervical (Cervix)

• Registration Number: ACTRN12606000167561
• Lead Sponsor: Investigator initiated trial (name of investigator is Dr Michelle Grogan) coordinated by the University of Sydney.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in average weekly haemoglobin concentrations between experimental and control groups.[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 Measures

Name	Time	Method
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.[This analysis is due to take place two years after recruitment start date (approx May 2008).]