Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer
NCT ID: NCT04070976
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
82 participants
INTERVENTIONAL
2019-07-01
2024-12-30
Brief Summary
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Detailed Description
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The data obtained by this protocol will allow to determine the effect of hypofractionated radiation therapy and its possible adverse effects. Side effects will be classified according to version 4.03 of CTCAE guidelines. The highest CTCAE grade will be obtained for each type of event, for each patient and the Radiation Therapy Oncology Group (RTOG) scale will be applied to evaluate the events related to conventional and hypofractionated radiotherapy, as well as brachytherapy.
Quality of life (QOL) will be evaluated using EORTC QLQ-CX24 and EORTC QLQ-C30, both have been validated and available in Mexican Spanish.
Direct and indirect expenses related to the treatment will be evaluated based on the treatment costs stipulate by the institution and the information obtained by the social workers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard treatment
Cisplatin 40mg/m2 weekly and concomitant pelvic radiotherapy (45 Gray/25 fractions) followed by brachytherapy 28Gray at point A.
Standard therapy
All patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
Experimental treatment
Cisplatin 40mg/m2 weekly and hypofractionated concomitant external radiotherapy (37,50 Gray/15 fractions) followed by brachytherapy 28 Gray at point A.
Hypofractionated therapy
All patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
Interventions
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Hypofractionated therapy
All patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
Standard therapy
All patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
Eligibility Criteria
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Inclusion Criteria
* Cervical Cancer at IIIA, IIIB y IIIC1 FIGO´s clinical stages
* Histology: squamous, adenosquamous or adenocarcinoma
* No previous treatment
* No distance metastases, discard by Positron Emission Tomography (PET)/CT
* Functional State ECOG (Eastern Cooperative Oncology Group) 0-2
* Complete Blood count obtained at least 14 days before admission to the study with adequate bone marrow function defined as:
* Absolute neutrophil count ≥ 1,500 cell/mm3
* Platelets ≥ 100,000 cell/mm3
* Hemoglobin ≥ 10.0 g/dl
* Leukocyte count ≥ 4000 cell/mm3
* Adequate Renal Function defined as:
* Serum Creatinine ≤ 1.5 mg/dl within 14 days before admission to the study
* Patients with HIV infection (human immunodeficiency virus) must have a CD4 cell count ≥ 350 cells / mm3 measured within 14 days prior to study entry (no HIV test is required)
* The patient must understand the protocol and provide the specific informed consent of the study before admission
* Negative pregnancy test
Exclusion Criteria
* Previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum (For example, breast cancer or oral cavity cancer)
* Previous systemic chemotherapy for current cervical cancer, take into account that prior chemotherapy for a different cancer is accepted, as long as they have been at least 3 years
* Severe active or non-controlled co-morbidities, defined as:
* Unstable angina and/or congestive heart failure that required hospitalization in the last 6 months.
* Transmural myocardial infarction in the last 6 months.
* Acute bacterial or fungal infection requiring intravenous antibiotics at the beginning of the study.
* Chronic obstructive pulmonary disease exacerbation or another respiratory disease that requires hospitalization or that contraindicates the trial therapy at the time of admission.
* Crohn's disease or ulcerative colitis.
* Prior allergic reaction to cisplatin or other drugs based on platinum.
* Other factors that contraindicate experimental therapy.
18 Years
FEMALE
No
Sponsors
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National Institute of Cancerología
OTHER_GOV
Responsible Party
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David Cantu
Chief of clinical trials department
Principal Investigators
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David F Cantú-deLeón
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cancerologia de Mexico
Locations
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David Cantu de Leon
Mexico City, Tlalpan, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Human papillomavirus (HPV) and cervical cancer \[Internet\]
Other Identifiers
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019/036/ICI
Identifier Type: -
Identifier Source: org_study_id
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