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

Inquiry into pathologic response, complications, and overall survival in patients with locally advanced cervical cancer treated by neo-adjuvant chemotherapy and surgery

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017090236033N1
Enrollment
30
Registered
2017-10-22
Start date
2016-12-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced cervical cancer. Malignant neoplasm of cervix uteri

Interventions

Intervention Group: The study has a single group. Pretreatment evaluation includes examination, pelvic magnetic resonance imaging, abdominal sonography, and chest x-ray. Patients receive three one-wee
Treatment - Drugs

Sponsors

Vice-chancellery for Research of Mashhad University of Medicla Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Elahe Aghel

Mashhad University of Medical Sciences

aghele941@mums.ac.ir+98 51 3842 6933

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026