Last updated: November 12, 2023
Sponsor: National Institute of Cancerología
Overall Status: Active - Recruiting
Phase
N/A
Condition
Cervical Cancer
Uterine Disorders
Treatment
Standard radiotherapy
Radical hysterectomy
hypofractionated radiotherapy
Clinical Study ID
NCT03750539
017/020/ICI
Ages 18-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients must have International Federation of Gynecology and Obstetrics (FIGO) stageIB2-IIB squamous, adenosquamous or adenocarcinoma of cervical with no disease outsideof 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 withadequate 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) Tlymphocytes 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 positivepatients with invasive cervical cancer and low CD4 cell counts is necessary becausethe treatments involved in this protocol may be significantly immunosuppressive.
- Chest x-ray and ultrasound must be performed within 12 (8 or 12) weeks before thestudy enrollment (I took out the ct scan of abdomen and pelvis)
- Patient must provide study-specific informed consent before study entry.
Exclusion
Exclusion Criteria:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease freefor 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 priorchemotherapy for a different cancer is allowable.
- Prior radiation therapy to the pelvis that would result in overlap of radiationtherapy fields.
- Severe active co-morbidity, defined as follows:
- Unstable angina or congestive heart failure requiring hospitalization within the lastsix months.
- Transmural myocardial infarction within the previous six months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time ofthe study entry.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illnessrequiring hospitalization or precluding study therapy at the time of study entry.
- Coagulation defects; note, however, that coagulation parameter are not required forentry into this protocol.
- Prior allergic reaction to cisplatin or other platinum drugs.
- Patients with para-aortic nodes or distant metastasis.
Study Design
Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Standard radiotherapy
Phase:
Study Start date:
November 10, 2017
Estimated Completion Date:
November 10, 2025
Study Description
Connect with a study center
David Cantu de Leon
Mexico City, Tlalpan 14080
MexicoSite Not Available
Instituto Nacional de Cancerologia
Mexico City, 14080
MexicoActive - Recruiting

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