NCT03899376

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: National Institute of Cancerología · Other Government
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
RADIATION	Volumetric modulated arc therapy	VMAT therapy focuses on reducing the dose radiation in adjacent organs at risk
RADIATION	conventional radiotherapy	Radiotherapy focus on pelvis area

Timeline

• Start date: 2018-09-10
• Primary completion: 2023-12-30
• Completion: 2024-03-15
• First posted: 2019-04-02
• Last updated: 2023-11-14

Locations

1 site across 1 country: Mexico