Clinical trial NCT04070976: Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer
Official title: Phase II Randomized Controlled Trial of Concomitant Chemoradiotherapy With Standard Fractionation Compared to Hypofractionated Concomitant Chemoradiotherapy Followed by Brachytherapy, for Clinical Stage III Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: hypofractionated radiotherapy
Brachytherapy
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2019-08-28
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Women over 18 years old
* 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:

* 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.

Primary outcomes:
measure: Acute and late toxicity
timeFrame: 2 years
Secondary outcomes:
measure: Treatment efficacy
timeFrame: 2 years
measure: Disease-free survival rate
timeFrame: 2 years
measure: Overall survival rate
timeFrame: 2 years
measure: Satisfaction assessed by EORTC
timeFrame: 2 years
measure: Direct and indirect costs related to treatment.
timeFrame: 2 years
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: David Cantu de Leon
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Cancerologia de Mexico
name: David F Cantú-deLeón
role: PRINCIPAL_INVESTIGATOR
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