Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Patients receive adaptive radiotherapy therapy and concurrent chemotherapy.

A dose of 45Gy will be delivered to planning target volume (PTV)

Online adaptive radiation therapy

In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

Online Adaptive Radiation Therapy for Rectal Cancer

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Rectal Cancer

evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0

Clinical and pathological complete response and partial response rate after chemoradiotherapy

evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme

Planing target volume V100%, defined as the planing target volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.

Margins needed in online ART for CTV to planning clinical target volume (PCTV) and GTV to planning gross tumor volume (PGTV) to cover inter/intra-fraction motion

Peking Union Medical College Hospital

Rare Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

40 patients treated with ART, using dose adaptation method to match the change of PTV and movement of OARs and achieve an optimal dose distribution using online CBCT images.

40 patients treated with original plan for full treatment course.

Replanning the treatment to adapt the change of PTV and movement of OARs to achieve an optimal dose distribution using online CBCT images.

Dose adaptation

Liu Hui, PHD.

Qiu Bo, PHD.

Deng Xiaowu, PHD

Liu Hui, PHD

Peng Yinglin, MD

Deng Xiaowu, PHD.

The purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive radiation therapy, ART) for esophageal cancer, using dose tracking technique with online images and deformable registration.

The aim of study is to evaluate the benefit of adaptive radiation therapy(ART) for esophageal cancer. 80 patients with locally advanced esophageal cancer will be treated with 3D-CRT(three dimensional conformal radiotherapy, 3D-CRT)/IMRT(intensity modulated radiotherapy, IMRT), dividing to experimental group and control group (40 patients each). All patients are kVCT(kilo-voltage computed tomography, kVCT) scanned weekly(the fifth fraction in a week) and CBCT (cone beam computed tomography, CBCT) scanned per fraction before treatment. Irradiated dose distribution of each patient is calculated using the CBCT images corrected with validated modelling and accumulate the volumetric dose for all PTV(planning target volume,PTV) and OARs(organs at risk, OAR) using deformable registration algorithm. For the experimental group, replan the treatment when the target volume is not covered by the prescribed dose or OARs is overdose beyond the action level to achieve an optimal dose distribution. Conversely, no action is taken in the control group and the original plan will be used for the full treatment course. Dosimetric parameters (such as the ratio of target coverage, the mean dose of OARs, etc) ,treatment toxicities (such as radiation pneumonitis and esophagitis), PFS（Progress Free Survival,PFS）and OS（Overall Survival, OS）of the two groups will be analyzed and compared in the study.

The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer

Accumulated dose distribution of the full treatment course.

Evaluating the treatment toxicity weekly during treatment course and at the time of one year after treatment according to the NCI CTCAE 4.0 (The National Cancer Institute Common Terminology Criteria for Adverse Events,NCI-CTCAE, Version 4.0).

the length of time during and after the treatment of a disease

The survival time from the start of treatment to death or the time of the last follow-up of this study.

Sun Yat-sen University

Director of radiotherapy department

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

Urinary Bladder Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cone-beam CT images as well as MRI scans will be used to make any changes to the radiation treatment plan, part of the way through the treatment. Adaptation of treatment plans may allow smaller target volumes to be treated with higher doses, while minimizing the side effects to surrounding organs.

Adaptive Radiation Therapy

Peter Chung, MD

Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).

A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

Difference in dose-volume irradiation of critical organs between original and adapted plan will be compared.

To determine a preliminary measure of toxicity with this technique. CTCAE toxicity data will be described for this population.

Bladder Utility Symptom Scale (BUSS) questionnaires will be scored and analyzed to determine QoL function. BUSS will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable

Expanded Prostate Cancer Index Composite (EPIC) questionnaires will be scored and analyzed to determine QoL function. EPIC will be scored (1-100) as per standard criteria. Data will be analyzed as a continuous variable

For prostate patients, patients will be considered to have biochemical failure if the PSA has risen 2ng above nadir.

Local control will be defined by an absence of clinically locally recurrent disease

Feasibility will be determined by analyzing the quality of target delineation using fiducial markers in bladder cancer patients.

University Health Network, Toronto

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Patients will be treated by preoperative or definitive radiotherapy for a limb STS, using an intensity-modulated conformal irradiation (with a static or dynamic technic), over 5 to 7 consecutive weeks. The total dose delivered will be of 50 Gray (preoperative RadioTherapy), or 60 to 70 Gray (exclusive RadioTherapy).

Adaptive radiation therapy

Dominique Genre, MD

Sandra Cournier

Laurence MOUREAU-ZABOTTO, MD

Soft tissue sarcomas (STS) is generally treated by surgery, followed or preceded by radiotherapy and chemotherapy. Preoperative irradiation has been shown to be effective in a randomized trial, and is often indicated in locally advanced Soft tissue sarcomas of the limbs, in order to reach R0 resection, or in case of rapid tumor growth despite first chemotherapy. For inoperable sarcomas, radiotherapy is an efficient palliative treatment, increasing local control.

Adaptive radiotherapy is defined as the set of procedures leading to the modification of a treatment plan based on the individual variations observed during irradiation. The place of this technique is increasing since the development of image-guided-radiotherapy allowing the visualization of daily variations in position, shape or volume of the tumor and organs at risk. Its implementation in current practice however remains limited because of the cumbersome processes involved (new delineation, new dose calculation, or even re-optimization) and resources to commit, especially in human time.

Irradiation of soft tissue sarcomas always begins with a planning CT scan, where the target-volumes and organ at risk are delineated, and dosimetric calculations are performed prior to radiotherapy initiation. During the radiotherapy, the variations leading to a mismatch between the planned dose and the dose delivered are multiple. These may be due to positioning errors or morphological changes in the patient (weight loss), or in the tumor or organs at risk (modifications in shape, size or position). The volume of soft tissue sarcomas changes also during radiotherapy (response, progression or pseudo- progression of the tumor).

However, to date, few data are available in the literature both on the volume variation of soft tissue sarcomas during preoperative radiotherapy, and on the interest of adaptive radiotherapy in the management of these tumors. It is therefore necessary to evaluate whether modifications of growth or macroscopic tumor volume are observed during the treatment, and to evaluate dosimetric impact on the target volume coverage that could impact the results of the treatment.

This a prospective multicentric phase II trial conducted to evaluate the interest of adaptive radiotherapy in the preoperative or exclusive management of limb sarcomas Patients will be treated by preoperative or definitive radiotherapy for a limb soft tissue sarcomas, using an intensity-modulated conformal irradiation (with a static or dynamic technic), over 5 to 7 consecutive weeks. The total dose delivered will be of 50 Gray (preoperative radiation therapy), or 60 to 70 Gray (exclusive radiation therapy). The delineation of growth or macroscopic tumor volume,clinical target volume, and planning target volume, as well as healthy surrounding tissues will be carried out in each of the centers, and under the responsibility of the radiotherapist, on The simulation CT-scan, used for dosimetry, and 3 CT scan performed on day 1 of radiotherapy (d1), at a dose of 30Gy (d30Gy) and 50Gy (d50GY). The dosimetric re-planning according to the variations of the volume of the planning target volume will be done in case of significant variation of the target volume according to de definition mentionned in the main and secondary objectives.

Main objective: The aim of this study is to evaluate the interest of adaptive radiotherapy in the preoperative or exclusive management of limb sarcomas.

This is the first prospective trial focused on the evaluation of the volume variation of soft tissue sarcomas during preoperative radiotherapy, and also on the interest of adaptive radiotherapy in the management of these tumors, whereas indications of preoperative and/or exclusive radiation therapy are very frequent.

Evaluation of Adaptive Radiation Therapy in Pre-operative or Exclusive Radiation Therapy for Limb Soft Tissues Sarcomas

Phase II Study Evaluating Adaptive Radiation Therapy in Pre-operative or Exclusive Radiation Therapy for Limb Soft Tissues Sarcomas

proportion of patients with clinically significant variations in growth or macroscopic tumor volume. Will be considered clinically significant the following variations of more than 10%

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Online Adaptive Radiation Therapy for Rectal Cancer	NCT05911789	Rectal Cancer	Online adaptive...	18 Years -	Peking Union Medical College Hospital
The Clinical Physics Research of Image Guided Adaptive Radiation Therapy for Esophagus Cancer	NCT02653521	Esophageal Canc...	Dose adaptation	18 Years - 70 Years	Sun Yat-sen University
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
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer	NCT03909893	Prostate Cancer Bladder Cancer	Adaptive Radiat...	18 Years -	University Health Network, Toronto
Online Adaptive Radiation Therapy for Rectal Cancer	NCT05911789	Rectal Cancer	Online adaptive...	18 Years -	Peking Union Medical College Hospital
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
A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer	NCT03909893	Prostate Cancer Bladder Cancer	Adaptive Radiat...	18 Years -	University Health Network, Toronto
Evaluation of Adaptive Radiation Therapy in Pre-operative or Exclusive Radiation Therapy for Limb Soft Tissues Sarcomas	NCT03680430	Sarcoma, Soft T...	Adaptive radiat...	18 Years -	Institut Paoli-Calmettes

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