Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region

breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region

radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region

hypofractionation radiotherapy

conventional fractionation radiotherapy

shu-lian wang, M.D.

Ye-xiong Li, M.D.

The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse

Chinese Academy of Medical Sciences

M.D.

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

Participants in this group will receive the EHRT intervention over a period of 6 weeks.

Participants in this group will receive the AHRT intervention over a period of 2 weeks.

A total dose of 70.2 Gy will be delivered in 26 fractions, 2.7 Gy to the Planning Target Volume (PTV) by Intensity Modulated Radiotherapy (IMRT) with stationary gantry or rotating gantry technique.

Extended Hypofractionation Radiotherapy

A total dose of 36.25 Gy will be delivered in 5 fractions, 7.25 Gy each to the Planning Target Volume (PTV), by Stereotactic Body Radiotherapy (SBRT) techniques.

Accelerated Hypofractionation Radiotherapy

Jacqueline Rodriguez Amado

Jacqueline C Rodriguez Amado

Matthew Abramowitz, MD

Alan Pollack, MD, PhD

Thomas Eade, M.B.B.S.

Clare Banks

Umberto Ricardi, MD

Gabriella Furfaro

Mario Levis, MD

Alessia Guarnei, MD

Sara Bartoncini, MD

Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to two-year failure defined as a positive biopsy two years post treatment completion or earlier evidence of biochemical or clinical failure.

Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

Reported will be the percentage of participants achieving either a biochemical or clinical failure or positive biopsy. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one. Clinical failure will be reported as any clinical evidence of local progression or recurrence. A positive biopsy will be concluded via histological evaluation.

Toxicity will be reported as the incidence of treatment related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) toxicity. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Efficacy will be reported as the percentage of participants achieving biochemical or clinical failure between participants with low and early intermediate risk for prostate cancer. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one. Clinical failure will be reported as any clinical evidence of local progression or recurrence.

Rate of death from prostate cancer will be reported.

Overall survival will be reported as the elapsed time from randomization to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.

American Society for Therapeutic Radiation and Oncology (ASTRO) Consensus Definition (ACD) failure is defined as three consecutive rises in post-treatment PSA, measured at the specified follow-up intervals.

Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.

Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. The questionnaire has 5 subscales (Urinary Function, Urinary Symptoms, Bowel Habits, Sexual Function and Hormonal Function). Each subscale has a total score ranging from 0-100, with higher scores representing better HRQOL.

Late occurring toxicity will be reported as the incidence of treatment related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) toxicity occurring more than three months after treatment completion. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Jay L. Friedland MD Prostate Cancer Research Fund

University of Miami

Assistant Professor of Clinical

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

hypofractionation radiotherapy combined with sintilimab,GM-CSF and Fruquintinib in the third-line or above treatment of MSS Metastatic Colorectal Carcinoma(mCRC)

Patients will receive radiation to the target lesion at a dose of 5Gy, 5 fractions a week, or a dose of 8Gy, 3 fractions a week. The course last once or twice depending on the investigator.

hypofractionation Radiotherapy

200 mg per IV infusion every 21 days until disease progression or participant withdrawal from study or last for two years

sintilimab

200µg given 7-14 days(until WBC≥40x109/L), every 21 days until disease progression or participant withdrawal from study or last for two years.

GM-CSF

Fruquintinib will be given 5mg qd for 2 weeks on and 1 week off, Q3W.

Fruquintinib

Mingquan Cai

Xiyi Liao

To evaluate the clinical efficacy and safety of hypofractionation radiotherapy combined with sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC)

Condition or disease:MSS Metastatic Colorectal Carcinoma (mCRC)

Phase:Phase 2

Intervention/treatment:

Radiation: hypofractionation radiotherapy

Drug: sintilimab, GM-CSF , Fruquintinib

Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC

A Trial of Hypofractionation Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC)

Defined as the time from the date of the first dose of treatment to the date of the first documentation of disease progression or death, whichever occurs first.

Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

Disease Control Rate（DCR）according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

Duration of Response(DOR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

Defined as the time from the date of the first dose of treatment until the date of death due to any cause.

Percentage of Participants With Adverse Events (AEs) Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE) for Adverse Events, version 5.01

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer	NCT00793962	Breast Cancer	hypofractionati... conventional fr...	18 Years - 75 Years	ChineseAMS
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer	NCT00793962	Breast Cancer	hypofractionati... conventional fr...	18 Years - 75 Years	ChineseAMS
Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer	NCT01794403	Prostate Cancer	Extended Hypofr... Accelerated Hyp...	35 Years - 85 Years	University of Miami
Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC	NCT05292417	Colorectal Neop...	hypofractionati... sintilimab GM-CSF Fruquintinib	18 Years - 80 Years	The First Affiliated Hospital of Xiamen University

Spots Global Cancer Trial Database for hypofractionation radiotherapy