How To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
How To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
1. This strategy might suggest a therapeutic option to preserve ovarian function in young
 patients among which locally advanced cancer cervix is common. Based on previous
 studies, neoadjuvant irinotecan and cisplatin followed by radical hysterectomy and
 adjuvant chemotherapy has the potential to improve the prognosis compared the concurrent
 chemo-radiotherapy(CCRT).

 2. To offer an alternative effective treatment line replacing concurrent chemo-radiotherapy
 to avoid dramatic radiotherapy induced complications which might impede a safe
 successful surgery.

 2- To reduce the proportion of patients who will go for radiotherapy, consequently those
 patients will still have a chance of probable less complicated surgery in case of local
 recurrence.

 3- This study will involve neo-adjuvant chemotherapy (NACT) in treating patients with stage
 II-III cervical cancer for reducing tumor size, minimizing blood loss during surgery and
 eradication of possible micro-metastasis.

 4- To Improve the likelihood of achieving complete tumor resection after NACT. 5-
 Investigators will further follow-up those patients for more detailed assessments to confirm
 whether NACT can improve patients' prognoses, survival, quality of life, and the standard of
 care.
Treatments for locally advanced cervical cancer, defined as International Federation of
 Gynecology and Obstetrics (FIGO) stage Ib2-III include primary surgery, neoadjuvant
 chemotherapy and concurrent chemo-radiotherapy (CCRT). In many countries, CCRT is accepted as
 the standard therapy for such tumors. However, each of these therapies has both advantages
 and disadvantages, however, more recently it has been given using neoadjuvant chemotherapy
 with intravenous irinotecan hydrochloride (CPT-11) and cisplatin. DNA topoisomerases are
 enzymes that regulate and control DNA topology. Topoisomerase 1 catalyzes the transient
 cutting of a single DNA strand, the passage of another DNA strand through the break and then
 resealing of the DNA break. Camptothecin (CPT), an antitumor alkaloid isolated from
 Camptotheca acuminata, interferes with DNA topoisomerase 1 function. Cisplatin
 (cis-dichlorodiammineplatinums II) is a first generation platinum compound. Platinum-based
 NACT followed by radical hysterectomy has been proposed as an alternative approach to
 radiotherapy or CCRT in locally advanced cervical cancer, especially of squamous cell
 histology, with objective response rates ranging from 69.4% to 90.2%, pathological optimal
 response rates ranging from 21.3% to 48.3%, 5-year disease free survival (DFS) rates ranging
 from 55.4% to 71% and 5-year overall survival(OS) rates ranging from 58.9% to 81%,
 respectively.
Inclusion Criteria:

 1 - Patients with histologically confirmed invasive squamous cell carcinoma of the uterine
 cervix; (ii) FIGO stage system (2018 version): stage II-III 2- No previous treatment. 3-
 patients with age of 20-75 years at enrollment. 4- Eastern Cooperative Oncology Group
 performance status (PS) of 0 or 1. 5- Preserved function of major organs (bone marrow,
 heart, liver and kidney) 6- Lab values within specified ranges, including a neutrophil
 count greater than 2000/μL, a platelet count greater than 100 000/ mm3 , a hemoglobin level
 greater than 9.0 g/dL (values after blood transfusion are accepted), levels of aspartate
 aminotransferase and alanine aminotransferase less than 100 IU/L, a total bilirubin level
 less than 1.5 mg/dL, a serum creatinine level less than 1.5 mg/dL, creatinine clearance
 greater than 60 mL/ min.

 Exclusion Criteria: :

 1. Distinct evidence of infectious disease.

 2. Serious concurrent disease (cardiac disease, uncontrolled diabetes mellitus, malignant
 hypertension and a bleeding tendency).

 3. Pregnant women, or women who want to become pregnant.

 4. History of serious drug hypersensitivity or drug allergy.