Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Ultra-hypofractionated radiation: Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

Ultra-hypofractionated whole breast radiotherapy

Standard Radiation

Eduardo Barbieri

Alayne Yamada, PhD

The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.

This is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.

Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

To estimate and compare the rate of local recurrence between the experimental and control arms.

Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.

Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.

To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.

To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.

To evaluate acute toxicity rate. The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using RTOG (Radiation Therapy Oncology Group).

To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.

To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS). Scores are interpreted according to the guidelines of the Scoring Manual. The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.

Instituto Brasileiro de Controle do Cancer

Principal Investigator

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Cisplatin

Antineoplastic Agents, Immunological

cisplatin 30 mg/m2/week I.V. during radiotherapy

cisplatin

3-dimensional conformal radiotherapy planning and delivery, 35x2 Gy/day over 7 weeks

radiotherapy

cetuximab 400 mg/m2 I.V. 1 week before the start of radiotherapy, cetuximab 250 mg2/week I.V. during radiotherapy

cetuximab

Primož Strojan, Prof.

Marta Dremelj, MD, MSc

Igor Fajdiga, MD, PhD

Cvetka Kuhar Grašič, MD, PhD

Jančar Boris, MD, MSc

Simona Jereb, MD

Katarina Karner, MD, MSc

Barbara Žumer, MD

Branko Zakotnik, Prof.

The therapy of patients with locally advanced head and neck cancer will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy (radiotherapy and Cisplatin.

Background: According to literature, the treatment results in irradiated patients who develop intensive skin reaction after concomitant Cetuximab administration appear improved as compared to the results of standard combination of radiotherapy and Cisplatin. In other patients, no beneficial effect of Cetuximab is expected and the therapy with Cisplatin (concomitantly with irradiation) is more effective in this group.

In this proposed single-institution non-randomized phase II study on patients with locally advanced squamous cell carcinoma of the head and neck, the therapy will be adjusted to the grade of skin rush as recorded after the first two cycles of Cetuximab and Cisplatin, i.e. either with radioimmunotherapy (radiotherapy and Cetuximab) or radiochemotherapy (radiotherapy and Cisplatin).

Methods: In the patients with inoperable tumors, induction chemotherapy (Docetaxel 75 mg/m2, Cisplatin 75 mg/m2, 5-Fluorouracil 750 mg/m2 in continuous infusion days 1-5; repeated every 21 days for 4 cycles) will be administered. In the week before the first fraction of radiotherapy, all patients will receive a loading dose of Cetuximab (400 mg/m2) and combination of Cetuximab (250 mg/m2) and Cisplatin (30 mg/m2) during the first week of irradiation. After multidisciplinary assessment of the grade of skin rush, conducted at the end of the second week of irradiation, the patients will be grouped as follows: arm A - skin rush of CTCAE v3.0 grade \<2 will proceed with radiochemotherapy with Cisplatin; arm B - skin rush of CTCAE v3.0 grade \>=2 will proceed with radioimmunotherapy with Cetuximab.

The planned number of patients included in the study is 120 (arm A - 50, arm B - 70) and recruitment period is 3 years. The primary objective of the study is to determine radiologically the complete response rate 12-14 weeks after therapy. The secondary objectives are locoregional control, progression-free survival and overall survival at 2 years after therapy, acute and late toxicity.

Expected results: The expected complete response rate in patients treated with radiochemotherapy and those treated with radioimmunotherapy is 50% and 75%, respectively. We also expect the difference in an absolute survival gain between the groups to be 25%.

Treatment Selection According to Skin Reaction to Cetuximab

Skin Reaction to Cetuximab as Criteria for Treatment Selection in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Phase 2 Study

The primary objective of the study is to determine radiologically the complete response rate 12-14 weeks after therapy.

number of patients with adverse events graded according to the National Cancer Institute CTC v3.0 (as measure of safety and tolerability)

Locoregional control will be calculated from the first day of the therapy to the occurrence of the local and/or regional recurrence (whichever will occur first) or death from any cause other than distant metastasis.

Progression-free will be calculated from the first day of the therapy to the appearance of local or regional recurrence, distant metastases, secondary primary cancer or death from any cause.

Overall survival is defined as a time interval between the first day of therapy and death from any cause.

Institute of Oncology Ljubljana

Symptoms and General Pathology

Recurrence

Disease Attributes

40 Gy /15 fx / 3 weeks, 5 days per week, is a dose prescribed (after randomization ) for Breast Cancer patients indicated for adjuvant RTH after mastectomy

28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy is a dose prescribed (after randomization )for Breast Cancer patients indicated for adjuvant RTH after mastectomy

Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.

Hypofractionation Schedules for Breast Cancer patients after mastecomy

Momen Hassan, MSc.

Osama Yousof, MD

This is a prospective randomized Phase III trial to assess efficiency of two post mastectomy hypofractionation schedules (40 Gy /15 fx / 3 weeks, 5 days per week VS 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week) as adjuvant radiotherapy in female patients with breast cancer after mastectomy.

166 patients of breast cancer patients after mastectomy ( 83 patients in each arm ) will be randomize into 2 hypofractionation arms : Arm A: 40 Gy /15 fx / 3 weeks, 5 days per week . Arm B: 28.5 Gy delivered in 5 once-weekly fractions of 5.7 Gy each week.

Simulation:

Patient will be simulated on CT simulator using breast wedge with angle. Serials will be taken every 2 mm from upper neck down to mid abdomen.

Contouring:

CTVcw, CTVRNI will be contoured through RTOG guidelines . PTV is added as 0.5 cm all around CTV. Lungs, Heart, brachial plexus, spinal cord, esophageus and thyroid will be contoured as OAR. (www.rtog.org/CoreLab/ContouringAtlases/BreastCancerAtlas.aspx).

D)Dose Constraints:

Arm A:

PTV EVAL ( CW) : V90 % ≥ 90 %. - V105 % ≤ 5% - V107%≤ 3 %. Ipsilateral lung: V20 less than 20-25% - V 8 less than 35%- Contra lateral lung: V4 less 10 %. Heart: V16 less than 5% (Lt sided). V20 less than 5% (Lt sided). V16 is 0%.(Rt sided) V20 is 0% (Rt sided). Mean heart dose ≤ 320-400 cGy. Contra lateral breast : D max≤ 240 cGy. V 144 cGy less than 5 %. SCV : V90 % ≥ 90 %. Thyroid : Mean dose less than 35 Gy - V30 less than 50 %.

Arm B:

PTV EVAL ( CW) : V90 %≥ 90 %. - V105 %≤ 5% - V107%≤ 2 %.

Ipsilateral lung: V30%less than 15 -20% - V15% less than 30-35% - V5 % less than 50-55%.

Contra lateral lung : V5 % less than 5%. Heart :V25 % less than 5 % - V5 % less than 30 - 35 %. Contra lateral breast: V3 % less than 5 %. SCV : V90 % ≥ 90 %.

Follow up:

A)Weekly follow up will be done during sessions then regular clinical exam every 3 months to assess :

1. Acute and late toxicity regarding pain, pulmonary toxicity, dysphagia, skin toxicity and lymphedema.Assessment will be done according to RTOG and CTCv.5.
2. Any local (chest wall) recurrence, regional (nodal) recurrence.

B)Annual Mammogram. C)Any another investigation (once indicated)

RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients

Randomized Clinical Trial Comparing Two Adjuvant Radiotherapy Hypo Fractionation Schedules In The Treatment of Post Mastectomy Breast Cancer Patients

Grades of toxicity will be assessed according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria. Scoring starts with low grade toxicity sacle ( Grade 1 or 2) while Grade 3 or 4 considered High grade toxicity.

Common Toxicity Criteria v.5 ( Arm volume at CC.Grading done according to Interlimb Volume Difference.Interlimb volume difference \> 30 % is considered Grade 3 Lymphedema) and Cheng scale ( To detect proportion of patients having moderate or severe lymphedema (Grade 》II)

Local Recurrence Rate (LCR) including ipsilateral chest wall +/- regional nodal recurrence

National Cancer Institute, Egypt

Assistant Lecturer of Radiation Oncology

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Endocrine System Diseases

Endocrine Gland Neoplasms

Adenocarcinoma

Adenocarcinoma, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Papillary Thyroid Carcinoma

Extracapsular total thyroidectomy puls prophylactic central neck dissection

Total thyroidectomy

Extracapsular total thyroidectomy plus prophylactic central neck dissection

Total thyroidectomy + prophylactic central neck dissection

Marcin Barczynski, MD, PhD

The purpose of this study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative.

Several respected organizations have recently recommended that total thyroidectomy plus prophylactic central neck dissection should be the standard operation for papillary thyroid cancer. However, it is still unclear if this approach has any benefit on survival or locoregional control of the disease. In addition, potential advantages of this more aggressive surgical approach should outweigh the risk of morbidity. The purpose of this retrospective cohort study is to determine whether prophylactic central neck dissection is beneficial for patients with papillary thyroid cancer staged preoperatively as node negative. In this study outcomes of total thyroidectomy versus this plus prophylactic central neck dissection for papillary thyroid cancer are compared in a 10-year follow-up. Patients operated between 1993 and 1997 (n=282) underwent total thyroidectomy alone, whereas patients operated between 1998 and 2002 (n=358) underwent total thyroidectomy plus prophylactic central neck dissection.

Prophylactic Central Neck Dissection for Papillary Thyroid Cancer

Jagiellonian University

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Behaviors and Mental Disorders

Tonsillar Neoplasms

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Quality of Life

Radiotherapy with either photons or protons.

Radiotherapy

Maria Gebre-Medhin, MD

Iréne Schönström, RN

Ann-Sofie Fransson, MD

Hedda Haugen, MD

Mattias Olin, MD

Britta Lödén, MD

Anna Flejmer, MD

Michael Gubanski, MD

Björn Zackrisson, MD

Johanna Färlin, MD

Zahra Taheri Kadkhoda, MD

Zizana Lovasova, MD

Zuzana Lovasova, MD

Erik Lundin, MD

In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)/N0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored weekly according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Acute radiation morbidity scoring criteria and other side effects are graded according to (Common Toxicity Criteria for Adverse Events (CTCAE) v4.0

Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Late radiation morbidity scoring criteria and other side effects are graded according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy	NCT05665920	Malignant Breas...	Ultra-hypofract... Standard Radiat...	18 Years -	Instituto Brasileiro de Controle do Cancer
Treatment Selection According to Skin Reaction to Cetuximab	NCT01472653	Head and Neck C...	cisplatin radiotherapy cetuximab	18 Years - 70 Years	Institute of Oncology Ljubljana
Treatment Selection According to Skin Reaction to Cetuximab	NCT01472653	Head and Neck C...	cisplatin radiotherapy cetuximab	18 Years - 70 Years	Institute of Oncology Ljubljana
RCT Comparing 2 Radiotherapy HypoFractionation Schedules In Breast Cancer Patients	NCT04550910	Radiotherapy Si... Locoregional Re...	Hypofractionati...	18 Years - 75 Years	National Cancer Institute, Egypt
Prophylactic Central Neck Dissection for Papillary Thyroid Cancer	NCT01510002	Papillary Thyro...	Total thyroidec... Total thyroidec...	18 Years -	Jagiellonian University
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.	NCT03829033	Tonsil Cancer	Radiotherapy	18 Years -	Lund University Hospital

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