scholarly journals Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)—study protocol for a multicentre, randomized phase III trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Sanjoy Chatterjee ◽  
◽  
Santam Chakraborty
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Randomized Controlled ◽  
Link Type ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-Caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a 1-week (5 fractions) regimen of radiotherapy will be non-inferior to a standard 3-week (15 fractions) schedule. Methods We describe a multicentre, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy/15 fractions/3 weeks, while those in the experimental arm will receive a dose of 26 Gy/5 fractions/1 week (to the same volume). The use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy, respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality-assure radiotherapy practices across the nation at the same time. Along with the results of the FAST-Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (December 31, 2018) as well as the ClinicalTrial.gov website at NCT03788213 (December 28, 2018).

scholarly journals HYPOfractionated Radiation Therapy Comparing A Standard Radiotherapy Schedule (Over Three Weeks) with A Novel One Week Schedule in Adjuvant Breast Cancer: An Open-Label Randomised Controlled Study (HYPORT- Adjuvant): Study Protocol for a Multicenter, Randomized Phase III Trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background: Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule.Methods: We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter.Discussion: If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established.Trial Registration: The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xu-Ran Zhao ◽  
Hui Fang ◽  
Yu Tang ◽  
Zhi-Hui Hu ◽  
Hao Jing ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Systemic Treatment ◽  
Controlled Trial ◽  
Phase Iii ◽  
Postmastectomy Radiotherapy ◽  
Randomized Controlled ◽  
Link Type ◽  
Internal Mammary ◽  
To Receive ◽  
Positive Breast Cancer

Abstract Background Various randomized trials have demonstrated that postmastectomy radiotherapy (RT) to the chest wall and comprehensive regional nodal areas improves survival in patients with axillary node-positive breast cancer. Controversy exists as to whether the internal mammary node (IMN) region is an essential component of regional nodal irradiation. Available data on the survival benefit of IMN irradiation (IMNI) are conflicting. The patient populations enrolled in previous studies were heterogeneous and most studies were conducted before modern systemic treatment and three-dimensional (3D) radiotherapy (RT) techniques were introduced. This study aims to assess the efficacy and safety of IMNI in the context of modern systemic treatment and computed tomography (CT)-based RT planning techniques. Methods POTENTIAL is a prospective, multicenter, open-label, parallel, phase III, randomized controlled trial investigating whether IMNI improves disease-free survival (DFS) in high-risk breast cancer with positive axillary nodes (pN+) after mastectomy. A total of 1800 patients will be randomly assigned in a 1:1 ratio to receive IMNI or not. All patients are required to receive ≥ six cycles of anthracycline and/or taxane-based chemotherapy. Randomization will be stratified by institution, tumor location (medial/central vs. other quadrants), the number of positive axillary nodes (1–3 vs. 4–9 vs. ≥10), and neoadjuvant chemotherapy (yes vs. no). Treatment will be delivered with CT-based 3D RT techniques, including 3D conformal RT, intensity-modulated RT, or volumetric modulated arc therapy. The prescribed dose is 50 Gy in 25 fractions or 43.5 Gy in 15 fractions. Tiered RT quality assurance is required. After RT, patients will be followed up at regular intervals. Oncological and toxilogical outcomes, especially cardiac toxicities, will be assessed. Discussion This trial design is intended to overcome the limitations of previous prospective studies by recruiting patients with pN+ breast cancer, using DFS as the primary endpoint, and prospectively assessing cardiac toxicities and requiring RT quality assurance. The results of this study will provide high-level evidence for elective IMNI in patients with breast cancer after mastectomy. Trial registration ClinicalTrails.gov, NCT04320979. Registered 25 Match 2020, https://clinicaltrials.gov/ct2/show/NCT04320979

scholarly journals Effects of immunoglobulin plus prednisolone in reducing coronary artery lesions in patients with Kawasaki disease: study protocol for a phase III multicenter, open-label, blinded-endpoints randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Si-Yuan Lin ◽  
Lan He ◽  
Li-Ping Xie ◽  
Yin Wang ◽  
Yi-Xiang Lin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Coronary Artery ◽  
Kawasaki Disease ◽  
Maximum Dose ◽  
Controlled Trial ◽  
Phase Iii ◽  
Coronary Artery Lesions ◽  
Open Label ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Kawasaki disease (KD) is an acute systemic vasculitis of unclear etiology that mainly affects infants and young children. Strategies to reduce the incidence and severity of coronary artery lesions (CALs), the determinant factor in the long-term prognosis of KD, are currently a focus of studies on KD. Corticosteroids, preferred in the treatment of the majority of vasculitides, are controversial in the treatment of acute KD. In this trial, we will evaluate whether the addition of prednisolone to standard intravenous immunoglobulin (IVIG) plus aspirin therapy can reduce the occurrence of CAL in Chinese patients with KD. Methods This is a multicenter, prospective, open-label, randomized controlled trial, which is expected to be conducted in more than 20 hospitals in China and aims to assess the efficacy and safety of IVIG + prednisolone treatment versus standard treatment. Patients with KD who fulfill the inclusion and exclusion criteria will be recruited and randomized (1:1) to receive either a large dose of IVIG (2 g/kg over 12–24 h with a maximum dose of 60 g) + aspirin 30 mg/kg/d or IVIG (2 g/kg over 12–24 h) + aspirin 30 mg/kg/d + prednisolone (2 mg/kg/d with a maximum dose of 60 mg tapered over 15 days after normalization of C-reactive protein concentration). The primary outcome will be the occurrence of CAL at 1 month of illness. The follow-up duration for each participant will be set as 1 year. Patients and treating physicians will be unmasked to group allocation. Discussion This will be the first multicenter randomized controlled trial to evaluate the efficacy of IVIG + aspirin + prednisolone in Chinese pediatric patients with KD, which may provide high-level evidence for improving the initial treatment for acute KD. Trial registration ClinicalTrials.govNCT04078568. Registered on 16 August 2018.

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