Pathologic response, side-effects, and overall survival in cervical cancer under treatment with neo-adjuvant chemotherapy and surgery

Phase 2

Recruiting

• Conditions: locally advanced cervical cancer.; Malignant neoplasm of cervix uteri

• Registration Number: IRCT2017090236033N1
• Lead Sponsor: Vice-chancellery for Research of Mashhad University of Medicla Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Definitive pathologic diagnosis of squamous cell carcinoma; stages IB2, IIA2, and IIB based on the International Federation of Gynecology and Obstetrics classification; age between 18 and 70 years; World Health Organization performance of grade 2 or lower; adequate renal and hepatic function and bone marrow reserve (i.e., absolute granulocyte count equal to or above 2×103 per liter, platelet count equal to or above 100×103 per liter; hemoglobin equal to or above 8.0 grams per deciliter, and glomerular filtration rate equal to or above 50); feasibility of follow-up in the ordered time; and informed consent.
Exclusion criteria: history of injection of chemotherapy drug in four weeks before study; serious comorbidities, for example, cardiac disease, poorly controlled diabetes mellitus, malignant hypertension, or bleeding tendency; overt infection; multiple concurrent active cancers; neuropathy grade 2 or greater; pregnancy; and history of serious hypersensitivity or allergy to cisplatin and paclitaxel.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Edema. Timepoint: after each course of chemotherapy. Method of measurement: Clinical examination.;Clinical response of tumor to treatment. Timepoint: At the first presentation, after each cycle of chemotherapy, and after surgery. Method of measurement: Physical examination and pathology.;Overall survival. Timepoint: On year after initiation of treatment. Method of measurement: Physical examination.;Nausea. Timepoint: after each course of chemotherapy. Method of measurement: Physical examination.;Vomit. Timepoint: after each course of chemotherapy. Method of measurement: Physical examination.;Neutropenia. Timepoint: after each course of chemotherapy. Method of measurement: complete blood count.;Neuropathy. Timepoint: after each course of chemotherapy. Method of measurement: Clinical examination.