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

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ClinicalTrials.gov Identifier: NCT03899376
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
David Cantu, National Institute of Cancerología

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.


Condition or disease Intervention/treatment Phase
Gynecologic Cancer Radiation: Volumetric modulated arc therapy Radiation: conventional radiotherapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized open-label clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Open-label Trial Comparing Acute Toxicity in Patients With Gynecological Cancer Treated With Adjuvant Conventional Versus VMAT Radiotherapy.
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 15, 2021

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




Primary Outcome Measures :
  1. Acute Toxicity measured by toxicity scales [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Quality of life measured by questionnaire [ Time Frame: 1 year ]

    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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients with gynecological cancer with an indication of adjuvant radiotherapy after surgical treatment.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899376


Contacts
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Contact: David F Cantu-de Leon, MD, MSC, PhD +5215537093156 dfcantu@gmail.com
Contact: Bernardino G Santiago, MD, Msc +5215555077315 gabrielsantiagoconcha@gmail.com

Locations
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Mexico
David Cantu de Leon Recruiting
Mexico City, Tlalpan, Mexico, 14080
Contact: David F Cantu-de Leon, MD. Msc. Phd    +5215537093116    dfcantu@gmail.com   
Contact: Bernardino G Santiago, MD, Msc    +5215555077315    gabrielsantiagoconcha@gmail.com   
Sponsors and Collaborators
National Institute of Cancerología

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Responsible Party: David Cantu, Chief of clinical trial departament, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT03899376     History of Changes
Other Study ID Numbers: 018/053/ICI CE/1309/18
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Cantu, National Institute of Cancerología:
Gynecological Cancer
Radiotherapy
VMAT
Toxicity