Neoplasms

All Conditions

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Standard conventional Treatment Arm, IGRT

Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist

Adaptive Radiotherapy

Maja Guberina, PD Dr. med. (MD), specialist

Ina Grübel

Maja Guberina, PD Dr. med. (MD)

Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.

Online-adaptive radiotherapy (ART) makes it possible to adapt the dose distribution to the anatomical changes online immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard in radiotherapy. Here, a cone-beam CT (CBCT) is also performed at the beginning of each fraction, which is used to position the patients in relation to the radiation field arrangement of the initial radiation plan approved for the series. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations in the body from radiation fraction to radiation fraction, e.g. due to different rectum and bladder fillings.

In ART mode, the online adaptive treatment plan for the current treatment is then selected and approved by the specialist online onboard in all cases in which the current target volume for the tumor expansion is not sufficiently covered by the initial treatment plan pre-planned for the series with its planned tolerances, or surrounding normal tissue is exposed too much. If the ART plan does not show any clear dosimetric advantages over the reference plan, especially if the initial plan covers the target volume of the day well, there are no dose increases and the normal tissues are spared as intended, the initial radiation plan from the planning CT can also be used as in IGRT. The aim of this study is to treat at least 15 patients with locally advanced gynecological carcinoma (mainly cervical carcinoma, endometrial carcinoma, vaginal carcinoma), who are to receive definitive radiotherapy at the Department for Radiotherapy at the University Hospital Essen, in ART mode on the Ethos therapy device over an initial 10 radiation fractions. The dose distribution is always compared with the adaptive and the initial plan for the radiation series on the anatomy of the day by the specialist and medical physics expert. The aim of this study is to prospectively investigate what percentage of patients benefit from ART when using standard PTV margins and how to recognize the corresponding patients early in the series. Secondarily, it will be investigated in what proportion of patients the risk organ burden and the safety margins around the clinical target volume can be reduced with ART compared to IGRT and how large this reduction can be.

The EORTC and CTC AE toxicitiy scales and further assessment scales will be evaluated in order to quantify objective and subjective side effects.

Adaptive Radiotherapy in Patients With Gynecological Tumors

Prospective Randomized Validation of Adaptive Radiotherapy in Patients With Gynecological Tumors and Indication for Radiotherapy

Rectum, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Bladder, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Skin, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, \[score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)\]

Lymph-Edema, EORTC CTC-AE ( (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-3, \[score 1: nearly no toxicity, asymptomatic changes - score 3: worst outcome, severe symptoms; limiting self care ADL\]

University Hospital, Essen

PD Dr. med. (MD) M. Guberina (senior consultant, specialist)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Radiotherapy delivered as per standard of care Additional trans-perineal ultrasound (TPUS) imaging at three timepoints (1 x pre-treatment and 2 x treatment). Additional magnetic resonance imaging (MRI) pre-treatment.

Trans-perineal ultrasound and Magnetic resonance image acquisition

Imaging

Sophie Alexander

Julia Murray

This feasibility study is investigating the application of magnetic resonance imaging (MRI) and transperineal ultrasound (TPUS) to visualise potential sites of relapse and surrounding normal tissue in patient having post-operative prostate cancer radiotherapy. Structure visualisation on MRI and TPUS will be compared to current standard computer tomography (CT) and cone-beam computer tomography (CBCT) imaging.

Approximately 47,000 men are diagnosed with prostate cancer yearly in the UK, 15% of which receive surgery (radical prostatectomy) as primary treatment. Of these men one third develop recurrence after prostatectomy and are offered post-operative radiotherapy.

Radiotherapy is targeted at the area where the prostate used to be, this includes potential relapse sites (PRS); vesicourethral anastomosis, bladder neck and retrovesicle space. When planning post-operative radiotherapy, the lack of a visible target means surrounding normal tissue is used to guide clinical target volume (CTV) delineation. The CTV is the area of tissue to be treated to the full radiotherapy prescription and includes PRS. Typically, the CTV is defined on a radiotherapy planning computer tomography (CT) scan.

The CTV lies adjacent to the bladder and rectum and is highly susceptible to positional changes influenced by organ filling. To identify and correct for CTV displacement during daily radiotherapy a cone-beam CT (CBCT) is acquired, this is an image similar to a CT scan but taken immediately prior to treatment delivery.

CT visualisation of PRS has been reported as inadequate, increasing the risk of missing or miss-identifying CTV structures during radiotherapy planning and delivery. To compensate for restricted visualisation on CT and CBCT an additional 1cm circumference around the CTV is treated to the prescription dose, this volume is referred to as the planning target volume (PTV). This margin reduces the risk of missing the target however its inclusion of normal tissue increases the risk of patient toxicity.

We propose that visualisation of PRS and surrounding normal tissue structures is enhanced on magnetic resonance imaging (MRI) compared to CT and on transperineal ultrasound (TPUS) compared to CBCT. This project investigates the reality of this statement by quantifying the confidence and reliability with which anatomical structures can be identified and delineated on all four image types.

PINPOINT Feasibility Study

Pioneering Imaging Techniques for Optimising Dose Delivery in Post-Operative Prostate Radiotherapy. A Feasibility Study.

Reliability of anatomical structure visualisation determined by mean dice similarity coefficient (DSC) and mean surface-to-surface distance (MSSD) for delineated structures (urethra, bladder neck, VUA, retrovesicle space, penile bulb, pubic symphysis and rectum) on MRI, CT, TPUS and CBCT across observers. If DSC is ≥ 0.75 the structure is deemed to be reliably visible.

Frequency of anatomical structure visualisation by average user rating of urethra, bladder neck, VUA, retrovesicle space, penile bulb, public symphysis and anterior rectal wall visualisation on MRI, CT, TPUS, CBCT and fused multimodality imaging (CT, MRI, TPUS).

On TPUS, the distance (mm) between anterior rectal wall and posterior pubic symphysis measured every 30 seconds over 10 minutes and the distance (mm) between VUA and superior aspect of penile bulb measured every 30 seconds over 10 minutes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adaptive Radiotherapy in Patients With Gynecological Tumors	NCT06230549	Gynecological T... Adaptive Radiot... Radiation Curative Treatm... Optimization Adaptive Radiat... Image Guided Ra... Cervical Carcin...	Adaptive Radiot...	18 Years -	University Hospital, Essen
Adaptive Radiotherapy in Patients With Gynecological Tumors	NCT06230549	Gynecological T... Adaptive Radiot... Radiation Curative Treatm... Optimization Adaptive Radiat... Image Guided Ra... Cervical Carcin...	Adaptive Radiot...	18 Years -	University Hospital, Essen
PINPOINT Feasibility Study	NCT05481372	Prostate Cancer Image Guided Ra...	Imaging	18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for image guided radiotherapy