Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Arm A: Stereotactic radiotherapy to a dose of 66 Gy at the isocenter with 22 Gy per fraction in 3 fractions during one week with body frame fixation and a planning target volume with a 5 mm margin around the macroscopic tumour. A heterogeneous dose distribution is used so 45 Gy will cover the PTV.

Arm B: Conventionally fractionated radiotherapy to a dose of 70 Gy with 2 Gy per fraction in 35 fractions during 7 weeks with fixation in a vacuum pillow and a planning target volume with a 2 cm margin around the macroscopic tumour.

Margin between CTV and PTV of 5 mm in transversal direction (except for small targets (\<3cm) not fixed to thoracic wall or mediastinal structures, where margin should be 10 mm) and 10 mm in longitudinal direction. Planned heterogeneous dose distribution within the PTV with about 50% higher dose to the center compared to the periphery. Hypofractionation with 22 Gy times 3 at the isocenter (15 Gy at the periphery of the PTV)during one week will be used.

Stereotactic radiotherapy

Clinical target volume (CTV) comprises the Gross Tumor Volume (GTV), including its diffuse growth at the borders. Planning target volume (PTV) is defined as the CTV with a total margin of 2 cm in all directions. The patient will receive 35 fractions, with a dose of 2.0 Gy/fraction at the ICRU reference point to a total dose of 70 Gy. The treatments will be given five days a week. The total treatment time should be as close to seven weeks as possible. The aim is that the dose distribution should be as homogeneous as possible.

Conventionally fractionated radiotherapy

Jan Nyman, Ass. Prof

A randomized phase II study for medically inoperable stage I non-small cell lung cancer where stereotactic body radiotherapy in three fractions to 66 Gy is compared with conventionally fractionated radiotherapy to 70 Gy in 35 fractions.

This is a multicenter Scandinavian randomized phase II study of stereotactic hypofractionated radiotherapy with body frame versus conventionally fractionated radiotherapy for stage I medically inoperable non-small cell lung cancer patients. There is a 1:1 randomization between arm A: Stereotactic radiotherapy to a dose of 66 Gy with 22 Gy per fraction at the isocenter (45 Gy covers the PTV) in 3 fractions during one week with body frame fixation and a planning target volume with a 5 mm margin around the macroscopic tumour, and arm B: Conventionally fractionated radiotherapy to a dose of 70 Gy with 2 Gy per fraction in 35 fractions during 7 weeks with fixation in a vacuum pillow and a planning target volume with a 2 cm margin around the macroscopic tumour.

Stereotactic Precision And Conventional Radiotherapy Evaluation

A Multicenter Randomized Phase II Study of Stereotactic Hypofractionated Radiotherapy With Body Frame Versus Conventionally Fractionated Radiotherapy for Stage I Medically Inoperable Non-small Cell Lung Cancer

CTC version 3.0 will be used for acute and late toxicity

EORTC QLQ 30 + LC 14 questionnaire will be used

complete remission,partial remission or stable disease

Göteborg University

Karolinska Institutet

Ass. Prof. Jan Nyman

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Neoplasms

Endometrial Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients randomized to the conventional fractionation arm will be treated with intensity-modulated or volumetric arc therapy technique as per standard protocol.

Patients randomized to hypofractionation will be treated the stereotactic hypofractionated technique.

Dose prescribed is 45 Gy in 25 fractions (1.8 Gy per fraction) delivered daily over 5 weeks.

Conventional Fractionation

Dose prescribed is 30 Gy in 5 fractions (6 Gy per fraction) delivered every other day over 11 days. There will be a minimum of 36 hours and maximum of 96 hours between fractions. The entire course of treatment should be completed within no less than 10 days.

Hypofractionation

Anika Mohan

Nithla Mohanathas

Adam Gladwish, MD

Julia Skliarenko, MD

David D'Souza, MD

Lucas Mendez, MD

Vikram Velker, MD

Jasper Yuen, MD

Eric Leung, MD

Elizabeth Barnes, MD

Amandeep Taggar, MD

Melanie Davidson, MD

Andrew Loblaw, MD

Elysia Donovan, MD

Patrick Cheung, MD

Kathy Han, MD

Adjuvant radiotherapy (RT) plays an important role in reducing the risks of local recurrence after surgery in uterine cancers. Standard adjuvant pelvic radiation treatment targets the pelvic lymph nodes, the post-operative bed, and the upper vagina and is typically treated with intensity modulated radiation therapy (IMRT) which has been shown to improve patient reported gastrointestinal (GI) and genitourinary (GU) toxicities. Although pelvic radiation has been shown to be effective at decreasing locoregional recurrences, patient quality of life and experience can be significantly impacted as pelvic RT comprises of daily radiation for 25 daily treatments, which can be a substantial burden on patients with this disease. Hypofractionated radiotherapy to a dose of 30 Gy in 5 fractions (6 Gy given every other day) for adjuvant radiation treatment in uterine cancer is hypothesized to result in similar rates of acute gastrointestinal toxicities as conventional fractionated radiation.

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II

Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II: A Phase II Randomized Controlled Trial

To compare the acute bowel toxicities associated with hypofractionated vs conventional adjuvant pelvic radiation as measured by the The Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

To compare the acute bowel toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for endometrial cancers using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.

To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for endometrial cancers using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.

To compare the acute urinary toxicities associated with hypofractionated treatment and conventional fractionation in adjuvant pelvic radiation for uterine cancer as measured by EPIC.

To compare presence of tumour through physical exam or radiologic imaging between hypofractionated treatment and conventional fractionation.

To compare disease-free survival of hypofractionated treatment and conventional fractionation

To compare the effect of hypofractionated treatment and conventional fractionation on quality of life using the using EORTC (European Organisation for Research and Treatment of Cancer) core questionnaire (QLQ-C30) with EN-24 companion.

To measure correlations between GU toxicity and EORTC questionnaire versus GU toxicity and EPIC questionnaire.

Princess Margaret Hospital, Canada

Royal Victoria Hospital, Canada

Credit Valley Hospital

London Regional Cancer Program, Canada

Sunnybrook Health Sciences Centre

Principal Investigator

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Laryngeal Diseases

Laryngeal Cancer

Valentina B Krstevska

The aim of our study was to evaluate the value of two different altered fractionation schedules - hyperfractionation and accelerated fractionation with concomitant boost - in comparison with conventional fractionation in primary definitive radiotherapy for squamous cell carcinomas of the larynx, oropharynx or hypopharynx. The study began and was conducted while the only teletherapy unit in our department was the cobalt-60 machine. During that period we were expecting the installation of new sophisticated equipment. We assumed that the results of this study would be also able to show whether or not it would be rational to use the altered fractionation regimens on the new machines.

Eligible patients admitted from March 1999 to December 2000 were treated with conventionally fractionated radiotherapy. These patients represented the retrospective part of the study. Patients admitted between January 2001 and June 2004 were included in the prospective part of the study. Following the confirmation of their eligibility, altered fractionation schedule assignment was made after stratifying by site of origin (larynx vs oropharynx vs hypopharynx), Karnofsky performance score (60%-70% vs 80%-100%), and stage of disease (I and II vs III and IV). Patients were randomized to receive radiotherapy delivered using either hyperfractionation or accelerated fractionation with concomitant boost as a late accelerating component. Exceptions occurred when patients either refused treatment with two daily fractions or were not offered twice-a-day irradiation because of lack of machine time.

Radiotherapy Scheduling and Technique The conventionally fractionated radiotherapy schedule was 66-70 Gy in 6½ -7 weeks (one fraction of 2 Gy per day, 5 fractions per week), whereas the hyperfractionation treatment schedule was 74.4-79.2 Gy in 6.2-7 weeks (two fractions of 1.2 Gy per day, 10 fractions per week with interfraction interval of at least 6 hours; Figure 1). The treatment schedule in accelerated fractionation using concomitant boost consisted of daily fraction of 1.8 Gy, 5 days a week, up to 32.4 Gy including all sites of disease and electively irradiated areas of the neck, followed by two daily fractions for the last 11-12 days. The first daily fraction encompassed all sites of the disease and electively irradiated neck nodes using a dose of 1.8 Gy, and the second daily fraction was the concomitant boost delivered through reduced fields to encompass the gross disease only, using a fraction of 1.5 Gy up to total doses of 68.7-72 Gy in 6 weeks (Figure 1). The interval between the two daily fractions was at least 6 hours.

Altered and Conventional Fractionated Radiotherapy in Patients With Head and Neck Cancer

Hyperfractionation and Accelerated Fractionation in Comparison With Conventional Fractionation in Definitive Radiotherapy of Squamous Cell Carcinoma of Larynx, Oropharynx and Hypopharynx

Institute of Radiotherapy and Oncology, Macedonia

radiotherapy with conventional fractionation (5 x 2Gy per week)

radiotherapy with accelerated fraction (7 x 2 Gy per week)

In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.

conventional fractionation

In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.

accelerated fraction

Rebecca Bütof, Dr.

In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).

This study is a randomized multicentric trial. Within this study an accelerated irradiation schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for postoperative radiotherapy with photons or protons in patients with NSCLC. The primary endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall survival of patients, local recurrence-free and distant metastases-free survival after 36 months, acute and late toxicity as well as quality of life for both treatment methods.

Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).

Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.

Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).

The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.

The assessment of quality of life is carried out using the established EORTC QLQ-C30 questionnaire and the additional lung module QLQ-LC13. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit.

Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.

The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.

German Consortium for Translational Cancer Research

National Center for Radiation Research in Oncology Dresden/Heidelberg

Radiation Oncology Working Group of the German Cancer Society

Technische Universität Dresden

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

For the cumulative total dose of 39-45.9 Gy to the chest wall, a daily dose of 2.5-3.0 Gy is administered 13-17 fractions.

* Should be started within 3 months of completion of mastectomy or chemotherapy.
* Clinical target volume (CTV) may include regional lymph nodes.
* If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines.

For the cumulative total dose of 45-50.4 Gy to the chest wall, a daily dose of 1.8-2.0 Gy is administered 23-28 fractions.

* Should be started within 3 months of completion of mastectomy or chemotherapy.
* Clinical target volume (CTV) may include regional lymph nodes.
* If a tissue expander or implant is present at the time of radiotherapy planning, CTV contouring should be performed according to the ESTRO ACROP implant-based target delineation guidelines.

Radiation regimen of 2.5-3.0Gy x 13-17 fractions +/- sequential boost 0-7 fractions

Radiation regimen of 1.8-2.0Gy x 23-28 fractions +/- sequential boost 0-5 fractions

In Ah Kim, MD. PhD.

This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy and reconstruction surgery.

This study is a multicenter, randomized, phase 3 clinical trial. For breast cancer patients who underwent breast reconstruction after mastectomy, the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) were divided 1:1 and compared to reveal the non-inferiority with hypofractionation in terms of major complication rate.

I. Primary Objective

* To show the non-inferiority of major complication rate in reconstructed-breast between the hypofractionation radiotherapy group (experimental group) and the conventional fractionation radiotherapy group (control group) at 2 years after radiation therapy.
* The main complications are defined at those requiring hospitalization or surgery among complications.

II. Secondary Objective:

* Comparison of other side effects between the two groups.
* Comparison of complication rate stratified by reconstruction timing and type of reconstruction

  * Immediate implant-based reconstruction
  * Immediate autologous reconstruction
  * Delayed-immediate implant reconstruction (2-stage)
* Comparison of quality of life between the two groups.
* Comparison of local and regional control rates between the two groups.

III. Tertiary Objective:

* Comparison of cosmetic evaluations between the two groups.
* Dosimetry analysis for correlation between the occurrence of complications and the dose profile.

Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients

A Randomized Phase III Trial of Hypofractionated Versus Conventionally Fractionated Radiotherapy in Breast Cancer Patients With Reconstruction After Mastectomy

In each follow-up time, arm circumference is measured at 10 cm above the ipsilateral and contralateral anterior cubital fossa. Lymphedema is considered to be occurred if a difference of ≥10% between two measures.

Skin 3D reconstruction was performed based on the radiation therapy plan CT and breast CT at 24 months after radiotherapy. Using in-house software based on deep learning algorithm, cosmetic scores are produced and compared between groups.

* Unplanned re-hospitalization or re-operation for intervention
* Implant removal due to infection, autologous flap total failure (reconstruction failure)

• Baker Scale

* G1: the breast is normally soft and appears natural in size and shape
* G2: the breast is a little firm, but appears normal
* G3: the breast is firm and appears abnormal
* G4: the breast is hard, painful to the touch, and appears abnormal

NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0

* G1: Mild symptoms; intervention not indicated
* G2: Minimally invasive evacuation or aspiration indicated
* G3: Transfusion; invasive intervention indicated
* G4: Life-threatening consequences; urgent intervention indicated
* G5: Death

NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0

* G1: Localized, local intervention indicate
* G2: Oral intervention indicated (e.g., antibiotic, antifungal, or antiviral)
* G3: IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated
* G4: Life-threatening consequences; urgent intervention indicated
* G5: Death

NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0

* G1: Incisional separation, intervention not indicated
* G2: Incisional separation, local care (e.g., suturing) or medical intervention indicated (e.g., analgesic)
* G3: Fascial disruption or dehiscence without evisceration; revision by operative intervention indicated
* G4: Life-threatening consequences; symptomatic hernia with evidence of strangulation; fascial disruption with evisceration; major reconstruction flap, grafting, resection, or amputation indicated
* G5: Death

NIH-NCI Common Terminology Criteria for Adverse Events (CTCAE) Ver.5.0

* G1: Asymptomatic; clinical or diagnostic observations only; intervention not indicated
* G2: Symptomatic; simple aspiration indicated
* G3: Symptomatic, elective invasive intervention indicated

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Precision And Conventional Radiotherapy Evaluation	NCT01920789	Non-small Cell ...	Stereotactic ra... Conventionally ...	-	Swedish Lung Cancer Study Group
Stereotactic Precision And Conventional Radiotherapy Evaluation	NCT01920789	Non-small Cell ...	Stereotactic ra... Conventionally ...	-	Swedish Lung Cancer Study Group
Stereotactic Pelvic Adjuvant Radiation Therapy in Cancers of the Uterus II	NCT04890912	Endometrial Can...	Conventional Fr... Hypofractionati...	18 Years -	Sunnybrook Health Sciences Centre
Altered and Conventional Fractionated Radiotherapy in Patients With Head and Neck Cancer	NCT00291434	Head and Neck C...		18 Years - 75 Years	Institute of Radiotherapy and Oncology, Macedonia
Altered and Conventional Fractionated Radiotherapy in Patients With Head and Neck Cancer	NCT00291434	Head and Neck C...		18 Years - 75 Years	Institute of Radiotherapy and Oncology, Macedonia
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation	NCT02189967	Non-Small Cell ...	conventional fr... accelerated fra...	18 Years -	Technische Universität Dresden
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients	NCT05253170	Breast Cancer Radiotherapy; C...	Hypofractionati... Conventional Fr...	19 Years - 85 Years	Seoul National University Bundang Hospital
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation	NCT02189967	Non-Small Cell ...	conventional fr... accelerated fra...	18 Years -	Technische Universität Dresden
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients	NCT05253170	Breast Cancer Radiotherapy; C...	Hypofractionati... Conventional Fr...	19 Years - 85 Years	Seoul National University Bundang Hospital

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