Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer. ICORG 09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2020-03-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Post-operative radiotherapy is internationally accepted as standard practice in the management of high-risk endometrial cancer1. Whilst it has no proven impact on overall survival it significantly increases local control.

Conventional radiotherapy techniques (3-dimensional) utilise a 3 or 4 field beam arrangement to target the pelvis in order to treat those areas at risk of recurrence: the vagina, the parametrium and the pelvic lymph nodes. However, when using such a technique it is not possible to avoid irradiating sensitive normal tissues such as the bowel and bladder.

Toxicity data from international randomised control trials in endometrial cancer report significantly more haematological, gastrointestinal, genitourinary and cutaneous toxicites (all grades) in those who received pelvic irradiation compared to those who did not2,3. These trials delivered radiotherapy using 2 or 3-dimensional techniques.

Intensity Modulated Radiation Therapy (IMRT) is a newer but established radiotherapy technique in many tumour sites that allows us to much more tightly conform the radiation. It uses computer-generated beams to produce radiotherapy volumes that can avoid irradiation of normal tissues in the pelvis.

There are no randomised studies reported in the literature that compare 3-dimensional pelvic irradiation with IMRT in patients who have had surgery for endometrial cancer. However there are several small studies that report considerable sparing of normal tissues using IMRT and when compared retrospectively with conventionally treated patients demonstrate marked reductions in acute gastrointestinal and genitourinary toxicity4.

By delivering post-operative radiotherapy to the pelvis using IMRT (as opposed to the standard 3-dimensional technique) it is anticipated that whilst local control and survival will be unaffected acute and late toxicity will be reduced.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer

NCT04458402

Endometrial Cancer

COMPLETED NA

Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

NCT00334321

Endometrial Cancer

COMPLETED PHASE1

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II

NCT04890912

Endometrial Cancer

UNKNOWN NA

Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus

NCT00002459

Endometrial Cancer Sarcoma

COMPLETED PHASE3

Intensity Modulated Radiotherapy (IMRT) for the Pelvis Post-Hysterectomy

NCT00508703

Uterine Cancer Cervical Cancer Endometrial Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary Objective:

• To compare the incidence of acute grade \>2 GU and GI toxicity

Secondary Objectives:

* To establish in the context of a clinical research study the feasibility of implementing pelvic nodal irradiation using IMRT in gynaecological cancer
* To establish an Image-Guided pathway for gynaecological cancer radiotherapy incorporating

* Set-up errors and optimal margins for set-up uncertainty
* Investigation of effects of bladder filling and rectal preparation protocols on the planning target volume
* To estimate the rate of loco-regional control
* To evaluate Quality of Life
* To estimate the rate of disease-free survival
* To estimate the overall survival rate
* To compare the incidence of late GU and GI toxicity

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Cancer Gastrointestinal Complications Radiation Toxicity Urinary Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm B

Radiation: 45 Gy / 25 fractions pelvic radiotherapy using intensity modulated radiotherapy (IMRT) followed by 11 Gy / 2 fractions vaginal vault brachytherapy

Group Type EXPERIMENTAL

45 Gy/25 fractions

Intervention Type RADIATION

Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy

Arm A Control

Radiation: 45 Gy/25 fraction external beam pelvic radiotherapy delivered using a 3-dimensional planned technique followed by 11 Gy / 2 fractions vaginal vault brachytherapy

Group Type OTHER

45 Gy/25 fractions

Intervention Type RADIATION

Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

45 Gy/25 fractions

Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing adjuvant pelvic radiotherapy for histologically confirmed endometrial adenocarcinoma / serous carcinoma / papillary serous carcinoma / mixed histology (adenocarcinoma and serous) and following AJCC 2009 grade/stage:

* Grade 2: stage IB (LVSI +/or \>60yrs)
* Grade 3: stage IA and IB
* Grade 1-3: Stage II and IIIA, IIIB and IIIC1
* Surgery consisting of total hysterectomy, +/- bilateral salpingo-oophorectomy, +/- lymph node sampling
* Staging with imaging of pelvis and abdomen (either MRI or CT)
* ECOG PS 0-2
* Age ≥ 18 years
* Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria

* Previous radiotherapy to the pelvic region
* Patients in whom concurrent chemotherapy in planned
* Patients with macroscopic disease in situ
* History of inflammatory bowel disease
* Previous hip replacement
* Previous bowel surgery (excluding appendectomy)
* Patients with other syndromes/conditions associated with increased radiosensitivity
* The patient has or had other co-existing malignancies within the past 5 years other than non-melanoma skin cancer
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No