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

Sponsor
Assiut University
Study ID
NCT04789941
Phase
PHASE2
Status
Unknown

Conditions

  • Locally Advanced Cervical Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Mar 2021
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm of patients with locally advanced cancer cervix
    Single arm study to assess the efficacy and safety of use of neoadjuvant cisplatin and irinotecan in treatment of patients with locally advanced cancer cervix. A combined regimen of intravenous infusion of cisplatin 80mg/m2 on day 1 with irinotecan 60mg/m2 on day 1 and day 8 of every 21- day cycle for 3 cycles. Then, MRI pelvis will be used for assessment of disease response. According to RECIST criteria, patients who will develop at least stable disease, will be sent for radical hysterectomy. Afterwards, 6 weeks after the surgery, another 3 cycles of the same regimen will be given to the participants as adjuvant treatment.

Primary Outcome Measure

Respectability of the tumor [ Time Frame: Evaluation will be done by MRI pelvis after 3 cycles( of the 21- day cycle) of chemotherapy ]

Central Contacts

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