None listed
Conditions
Brief summary
This study looks at whether the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves outcomes in women with locally advanced cervical cancer. Who is it for? You can join this study if you have locally advanced cervical cancer which is suitable for primary treatment with chemoradiation and you have not received any previous pelvic radiotherapy. Trial details: Participants will be divided into two groups. Both groups will be treated with standard external beam radiation treatment to the pelvis and brachytherapy(internal radiotherapy). They will receive cisplatin intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. One group will also receive 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin and paclitaxel intravenously, beginning within 4 weeks of completion of all radiation treatment. The study aims to see whether the adjuvant chemotherapy increases the response to treatment and improves survival times.
Interventions
Patients will be treated with standard external beam radiation treatment to the pelvis and brachytherapy. Cisplatin will be given intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. Within 4 weeks of completion of all radiation treatment, including the brachytherapy component, and following recovery from toxicities, patients will be treated with 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin (Area Under Curve (AUC) 5 and paclitaxel 155 mg/m2 intravenously.
Patients will be treated with standard external beam radiation treatment to the pelvis and brachytherapy. Cisplatin will be given intravenously during the radiation at a dose of 40mg/m2 weekly for 5 doses. Within 4 weeks of completion of all radiation treatment, including the brachytherapy component, and following recovery from toxicities, patients will be treated with 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin (Area Under Curve (AUC) 5 and paclitaxel 155 mg/m2 intravenously. The chemotherapy is administered once every 3 weeks for 4 cycles. Both drugs are admistered simultaneously over 3 hours.
Sponsors
The University of Sydney
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
No
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
Outcome results
None listed