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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Radiation: Volumetric modulated arc therapy
* Radiation: conventional radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized open-label clinical trial
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gynecological Cancer, Radiotherapy, VMAT, Toxicity