Cervical cancer (FIGO stage IB, II , III, IVA) Cancer Cervical cancer
Conditions
Interventions
Initial workup:
1. Complete physical examination
2. Pelvic examination without anaesthesia by at least two gynaecologists/oncologists
3. Chest X ray
4. Abdomino-pelvic spiral multi-detector Compute
Sponsors
Shaheed Beheshti University of Medical Science (SBMU) (Iran)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with untreated locally advanced cervical cancer International Federation of Gynaecology and Obstetrics (FIGO) stage IB, II, III, IVA 2. Histologically confirmed Squamous Cell Carcinoma (SCC) 3. Aged between 18 - 70 years 4. Performance status less than or equal to 2 in Eastern Cooperative Oncology Group (ECOG) scale 5. No active co-morbid illness (uncontrolled infection, cardiopulmonary disease, uncontrolled diabetes mellitus) 6. Laboratory data at start of chemotherapy: 6.1. Haemoglobin (Hb) 12 g/dl or corrected to 11 g/dl before the start of therapy 6.2. Platelets (Plt) 100 x 10^9/L 6.3. Absolute Neutrophil Count (ANC) more than or equal to 1.5 x 10^9/L 6.4. Creatinine (Cr) less than or equal to 1.5 x Upper Limit of Normal (ULN) 6.5. Billirubin less than or equal to 1.5 ULN 6.6. Aspartate Aminotransferase (AST) less than or equal to 2 x ULN 6.7. Alanine Aminotransferase (ALT) less than or equal to 2 x ULN
Exclusion criteria
Exclusion criteria: 1. Any metastatic disease 2. Previous pelvic irradiation 3. History of other malignancy except non-melanoma skin cancer 4. Disease out of the pelvis and para-aortic lymph nodes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two year disease free survival (time from completion of chemoradiation to first pathologically documented local recurrence or distant metastasis out of pelvis). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at the end of patient accrual: 1. Clinical complete response rate (complete disappearance of tumor radiologically and clinically in the first evaluation after treatment) 2. Toxicity profile according to the World Health Organization (WHO) criteria 3. Overall survival (time from completion of chemoradiation to death) | — |
Countries
Iran
Outcome results
None listed