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Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

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ClinicalTrials.gov Identifier: NCT04070976
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
David Cantu, National Institute of Cancerología

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: Hypofractionated therapy Radiation: Standard therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: Standard treatment
Cisplatin 40mg/m2 weekly and concomitant pelvic radiotherapy (45 Gray/25 fractions) followed by brachytherapy 28Gray at point A.
Radiation: 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: Experimental treatment
Cisplatin 40mg/m2 weekly and hypofractionated concomitant external radiotherapy (37,50 Gray/15 fractions) followed by brachytherapy 28 Gray at point A.
Radiation: 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.




Primary Outcome Measures :
  1. Acute and late toxicity [ Time Frame: 2 years ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG


Secondary Outcome Measures :
  1. Treatment efficacy [ Time Frame: 2 years ]
    Hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment

  2. Disease-free survival rate [ Time Frame: 2 years ]
    Number of participants dead of disease at two years according to kaplan-meyer analysis

  3. Overall survival rate [ Time Frame: 2 years ]
    Number ofpParticipants dead at two years according to kaplan-meyer analysis

  4. Satisfaction assessed by EORTC [ Time Frame: 2 years ]
    Assessed individual's overall satisfaction with life and general sense of personal well-being by ERTC QLQ-C30 and QLQ-CX24 questionaire

  5. Direct and indirect costs related to treatment. [ Time Frame: 2 years ]
    Direct costs related to the treatment. Indirect costs related to the treatment (transport, housing, food, etc.)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070976


Contacts
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Contact: David F Cantú-de León, Md, MSc. PhD +525537093156 dfcantu@gmail.com
Contact: Lenny N Gallardo-Alvarado, MD, MSc +52553702118 dra.ngallardo@yahoo.com

Locations
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Mexico
David Cantu de Leon Recruiting
Mexico City, Tlalpan, Mexico, 14080
Contact: David F Cantu-de Leon, MD. Msc. Phd    +5215537093116    dfcantu@gmail.com   
Sponsors and Collaborators
National Institute of Cancerología
Investigators
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Principal Investigator: David F Cantú-deLeón Instituto Nacional de Cancerología
Additional Information:
Publications:

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Responsible Party: David Cantu, Chief of clinical trials department, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT04070976    
Other Study ID Numbers: 019/036/ICI
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 2 years
Access Criteria: the data will be shared with scientific and academic institutions or research groups that study the same topic and with the regulatory and ethical authorities that require it, to ensure the quality and accuracy of the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Cantu, National Institute of Cancerología:
hypofractionated radiotherapy
Brachytherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases