Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical Cancer

November 12, 2023 updated by: David Cantu, National Institute of Cancerología

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David F Cantú-de León, Md, MSc. PhD
  • Phone Number: +525537093156
  • Email: dfcantu@gmail.com

Study Contact Backup

Study Locations

  • Mexico
    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • David Cantu de Leon
        • Contact:
          • David F Cantu-de Leon, MD. Msc. Phd
          • Phone Number: +5215537093116
          • Email: dfcantu@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and late toxicity
Time Frame: 2 years
Number of Participants With Treatment-Related Adverse Events as Assessed by RTOG
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficacy
Time Frame: 2 years
Hypofractionated radiotherapy is similar in toxicity and disease control compared to standard external beam treatment
2 years
Disease-free survival rate
Time Frame: 2 years
Number of participants dead of disease at two years according to kaplan-meyer analysis
2 years
Overall survival rate
Time Frame: 2 years
Number ofpParticipants dead at two years according to kaplan-meyer analysis
2 years
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
2 years
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.)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cancerología

Investigators

  • Principal Investigator: David F Cantú-deLeón, Instituto Nacional De Cancerologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019/036/ICI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

2 years

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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