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

NCT04789941 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-10

No results posted yet for this study

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.

Conditions

  • Locally Advanced Cervical Carcinoma

Interventions

DRUG

Cis Platinum + Irinotecan

Studying the efficacy and safety of neoadjuvant cisplatin and irinotecan use in treatment of locally advanced cancer cervix.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-12-30
Completion
2021-12-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789941 on ClinicalTrials.gov