NCT04789941

How To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix

Phase II Trial To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Cervical Carcinoma

Interventions

Type	Name	Description
DRUG	Cis Platinum + Irinotecan	Studying the efficacy and safety of neoadjuvant cisplatin and irinotecan use in treatment of locally advanced cancer cervix.

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2021-03-10
• Last updated: 2021-03-10