Weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Cervix; Cancer; Cervical cancer

• Registration Number: ISRCTN98873899
• Lead Sponsor: niversity College London (UK)

Brief Summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695016

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-11-28
• Study Start: 2010-04-29
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Histologically confirmed and reviewed at the cancer centre International Federation of Gynaecology and Obstetrics (FIGO) stage Ib2 - IVa squamous, adeno-, or adenosquamous carcinoma of the cervix suitable for radical chemoradiation
2. EUA, cystoscopy and sigmoidoscopy performed by Gynaecological Oncologist +/- Clinical Oncologist to confirm FIGO stage with biopsy of any suspicious lesions in bladder, vagina or rectum
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
4. Age over 18, no upper limit, providing patient deemed fit by supervising oncologist to receive chemoradiation
5. Adequate renal function, as defined by glomerular filtration rate (GFR) estimated by EDTA or creatinine clearance (24 hour urine) greater than or equal to 60 ml/min
6. Adequate liver function, as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 upper limit of normal (ULN), and bilirubin less than 1.25 ULN
7. Adequate bone marrow function, as defined by white cell count (WCC) greater than 3.0 x 10^9/litre, neutrophils greater than 1.5 x 10^9/litre, and platelets greater than 100 x 10^9/litre
8. Placement of ureteric stents in all patients with hydronephrosis regardless of renal function
9. Normal electrocardiogram (ECG)
10. Written informed consent

Exclusion Criteria

1. Pregnant or breast feeding patients
2. Previous diagnosis of cancer, except basal cell carcinoma (BCC) skin
3. Active cardiac disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified