Status:
UNKNOWN
Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer
Lead Sponsor:
National Institute of Cancerología
Conditions:
Cervix Cancer
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be rand...
Detailed Description
Toxicity will be assessed six times during this study. In addition to the primary endpoint of patient-reported gastrointestinal toxicity, a broad range of other toxicities will be comprehensively eval...
Eligibility Criteria
Inclusion
- Patients must have International Federation of Gynecology and Obstetrics (FIGO) stage IB2-IIB squamous, adenosquamous or adenocarcinoma of cervical with no disease outside of the pelvis by via ultrasound.
- No distant metastasis via chest X-ray.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age 18
- complete blood count (CBC)/differential obtained 14 days before study entry with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mim3
- Platelets 100,000 cells/mim3
- Hemoglobin 8.0 g/dl
- White blood count 4000 cell/m3
- An adequate renal function defined as follows:
- Serum creatinine 1.5 mg/dl within 14 days before study entry
- Patients with known HIV positive must have a cluster of differentiation 4 (CD4) T lymphocytes count be 350 cells/mm3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol). Excluding HIV positive patients with invasive cervical cancer and low CD4 cell counts is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Chest x-ray and ultrasound must be performed within 12 (8 or 12) weeks before the study enrollment (I took out the ct scan of abdomen and pelvis)
- Patient must provide study-specific informed consent before study entry.
Exclusion
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast or oral cavity.
- Patients cannot have any neuroendocrine histology in pathology.
- Prior systemic chemotherapy for the current cervical cancer, note that prior chemotherapy for a different cancer is allowable.
- Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields.
- Severe active co-morbidity, defined as follows:
- Unstable angina or congestive heart failure requiring hospitalization within the last six months.
- Transmural myocardial infarction within the previous six months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of the study entry.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry.
- Coagulation defects; note, however, that coagulation parameter are not required for entry into this protocol.
- Prior allergic reaction to cisplatin or other platinum drugs.
- Patients with para-aortic nodes or distant metastasis.
Key Trial Info
Start Date :
November 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03750539
Start Date
November 10 2017
End Date
November 10 2025
Last Update
November 14 2023
Active Locations (2)
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1
David Cantu de Leon
Mexico City, Tlalpan, Mexico, 14080
2
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080