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

A Randomized Open-label Trial Comparing Acute Toxicity in Patients With Gynecological Cancer Treated With Adjuvant Conventional Versus VMAT Radiotherapy.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Radiation: conventional radiotherapy; Radiation: Volumetric modulated arc therapy

Detailed Description

BACKGROUND:

The standard of care in gynecological malignancies with high-risk features of recurrence following surgery is adjuvant external beam radiation therapy (EBRT) in the pelvic region, with or without concurrent chemotherapy (CT). This treatment modality offers higher local control and improves overall survival. EBRT has been associated with secondary effects due to toxicity such as cystitis, enteritis and proctitis which can compromise its effectiveness, patient´s quality of life and the interruption of the treatment. Newer EBRT techniques reduce the radiation dosis in normal tissues, with less toxicity. So far, there are no records of radiation-induced toxic effects in our population. The aim of this study is to evaluate the acute toxicity associated with pelvic postoperative EBRT using conventional or VMAT (RapidArc) technique in patients with gynecological cancer.

METHODOLOGY:

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • David Cantu de Leon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional radiotherapy; patients with gynecological cancer treated with adjuvant conventional radiotherapy	Radiation: conventional radiotherapy; Radiotherapy focus on pelvis area
Experimental: Volumetric modulated arc therapy; Patients with gynecological cancer treated with adjuvant VMAT radiotherapy	Radiation: Volumetric modulated arc therapy; VMAT therapy focuses on reducing the dose radiation in adjacent organs at risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by questionnaire	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, previously validated in Mexican Spanish-speaking population. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	1 year

Collaborators and Investigators

• Sponsor: National Institute of Cancerología

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 31, 2019
• First Posted (Actual): April 2, 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: Radiotherapy; Toxicity; VMAT; Gynecological Cancer
• Other Study ID Numbers: 018/053/ICI CE/1309/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No