A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone

Phase 3

Active, not recruiting

• Conditions: ocally advanced cervical cancer; Locally advanced cervical cancer; Cancer - Cervical (cervix)

• Registration Number: ACTRN12610000732088
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-02
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

Stages IB1 and positive nodes, IB2, II, IIIB or IVa cervical cancer suitable for primary treatment with chemoradiation with curative intent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
- White Blood Cell (WBC) Count greater than or equal to 3.0 x 109/L and absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L
- Platelets greater than or equal to 100 x 109/L
- Bilirubin less than or equal to 1.5 x Upper limit of normal (ULN)
- Liver enzyme Asparate Amino Transferase (AST) or Amino Alanine Transferase (ALT) less than or equal to 2.5 x Upper limit of normal (ULN)
- Adequate renal function: calculated creatinine clearance (Cockcroft-Gault Formula) greater than or equal to 60ml/min or greater than or equal to 50 ml/min by Ethylenediaminetetraacetic acid (EDTA) creatinine clearance
- Written informed consent

Exclusion Criteria

- Any previous pelvic radiotherapy
- Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, positron emission tomography (PET) positive or greater than or equal to 15mm short axis diameter on computer tomography (CT)
- Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria
- Previous chemotherapy for this tumour
- Stage IIIA disease
- Evidence of distant metastases
- Prior diagnosis of Crohn’s disease or ulcerative colitis
- Peripheral neuropathy > grade 2
- Patients who have undergone hysterectomy or will have a hysterectomy as part of their initial cervix cancer therapy
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
- Patients who are pregnant or lactating
- Any contraindication to the use of cisplatin, carboplatin or paclitaxel chemotherapy
- Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV) positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival. Tools of assessment: patient medical records, follow-up visits[at 3 and 5 years following randomisation]