A Trial Comparing Acute Toxicity in Patients With Gynecological Cancer Treated With VMAT

NCT03899376 | Unknown

• 1 other identifier: 018/053/ICI CE/1309/18
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled, open-label, prospective and longitudinal clinical trial. Rectal, intestinal and bladder EBRT-related toxicity will be assessed according to RTOG / EORTC scales at the first day of EBRT, during the 2nd, 3rd and 4th week of treatment, and 1, 3 and 6 months after the end of radiation treatment. The assessment of quality of life (QoL) will be measured by completing the questionnaire of the European Organization for Research and the Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) version 3.0, in addition to specific QoL questionnaires for cervical and endometrial cancer respectively (EORTC QLQ-CX 24 and EORTC QLQ-EN24), previously validated in Mexican Spanish-speaking population, and which will be simultaneously applied with the RTOG / EORTC toxicity scales. EXPECTED RESULTS AND PERSPECTIVES: This trial aims to provide information about the feasibility of using a newer EBRT technique, as effective as conventional 3D-conformal radiation therapy (3D-CRT), but with less toxicity.

Conditions

Gynecologic Cancer

Keywords

Gynecological Cancer; Radiotherapy; VMAT; Toxicity

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity measured by toxicity scales

  The acute toxicity will be measured, with RTOG acute radiation morbidity scoring criteria scale, this has four grades from 0 to 4, and higher values represent a worse outcome. The principal symptoms to evaluate are genitourinary and lower gastrointestinal.

  1 year

Secondary Outcomes (1)

• Quality of life measured by questionnaire

  1 year

Study Arms (2)

Conventional radiotherapy

ACTIVE COMPARATOR

patients with gynecological cancer treated with adjuvant conventional radiotherapy

Radiation: conventional radiotherapy

Volumetric modulated arc therapy

EXPERIMENTAL

Patients with gynecological cancer treated with adjuvant VMAT radiotherapy

Radiation: Volumetric modulated arc therapy

Interventions

Volumetric modulated arc therapy RADIATION

VMAT therapy focuses on reducing the dose radiation in adjacent organs at risk

Volumetric modulated arc therapy

conventional radiotherapy RADIATION

Radiotherapy focus on pelvis area

Conventional radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: patients with gynecological cancer with an indication of adjuvant radiotherapy after surgical treatment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with cervical or endometrial cancer with an indication of adjuvant radiotherapy after surgical treatment.

You may not qualify if:

• patients that reject to participate in the trial
• previous treatment with pelvic radiotherapy

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

David Cantu de Leon

Mexico City, Tlalpan, 14080, Mexico

Location

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of clinical trial departament

Model Details: a randomized open-label clinical trial

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: April 2, 2019
• Study Start: September 10, 2018
• Primary Completion: December 30, 2023
• Study Completion: March 15, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)