Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    82
  • sponsor
    National Institute of Cancerología
Updated on 25 January 2021
cancer
metastasis
neutrophil count
brachytherapy
adenocarcinoma

Summary

The main goal of this trial is to assess the safety and response rate to concomitant chemotherapy and external hypofractionated radiotherapy followed by brachytherapy in patients with clinical stage III cervical cancer. The trial will take place in the National Cancer Institute (INCan). Patients will be randomized into two groups: chemotherapy with external standard fractionated radiotherapy (45 Gy in 25 fractions) followed by brachytherapy or chemotherapy with external hypofractionated radiotherapy (37.5 Gy in 15 fractions) followed by brachytherapy.

Description

The primary endpoint will be to assess the safety and efficacy to concomitant chemoradiotherapy followed by brachytherapy in cervical cancer clinical stage III. Secondary endpoints comprises security profile, survival rates, quality of life and related costs.

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.

Details
Condition Cervical Cancer, Cervical Cancer, Disorders of cervix NOS, Uterine Cancer, Uterine Cancer, cervical carcinoma, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix
Treatment Standard therapy, Hypofractionated therapy
Clinical Study IdentifierNCT04070976
SponsorNational Institute of Cancerología
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women over 18 years old
Cervical Cancer at IIIA, IIIB y IIIC1 FIGOs 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

Patients who had chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies
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
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