POstmastectomy radioThErapy in NodeposiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): A study protocol for a multicenter prospective phase III randomized controlled trial

- 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.
- 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..
- The results of this study will provide high-level evidence for elective IMNI in patients with breast cancer after mastectomy..
- The internal mammary node (IMN) chain is one of the major pathways of lymphatic drain- age in breast cancer.
- There is ongoing controversy regarding whether the IMN should be included in the radiation treatment volume, largely because of the un- confirmed survival benefit and the concerns for added risk of cardiac toxicity from IMN irradiation (IMNI)..
- node-negative breast cancer after mastectomy [10]..
- This study will provide high-level evidence for elective IMNI for patients with breast cancer.
- A flow chart giving an overview of the study design is shown in Fig.
- the incidence of contralateral non-invasive breast cancer or other malignant tumors.
- Histologically confirmed invasive breast cancer.
- 1 Flow chart of the POTENTIAL trial.
- Simultaneous bilateral breast cancer.
- No imaging assessment of the internal mammary node before systemic therapy.
- contrast-enhanced CT of the neck and thorax.
- Irradiation of level I axilla is at the discretion of the attending physician, considering the risk of axillary nodal recurrence and treatment-related lymphoedema.
- The delineation of the CTV of the chest wall, supra/infraclavicular fossa, and IMN (CTVcw, CTVsc, CTVim) is recommended in Table 1.
- It is required that 95% of the PTV receives 100% of the prescribed dose, the maximum dose (Dmax) of the PTV <.
- 120% of the prescribed dose, and the PTV receiving ≥110% of the prescribed dose is specified to be <.
- Electron fields are optional for irradiation of the chest wall and the IMN.
- When an electron field is used, it is required that 90% of the CTVim or CTVcw receive 90% of the pre- scribed dose.
- Chest wall bolus should be used for at least 40–60% of the course of RT.
- Chest wall Caudal edge of the sterno-clavicular joint.
- Caudal edge of the contralateral breast.
- Within 1 cm to the midline of the body (guided by palpable/.
- Skin surface Anterior edge of the pectoralis minor muscle.
- Caudal edge of the cricoid cartilage.
- Medial edge of the internal jugular vein, excluding the thyroid and the common carotid artery.
- Medial edge of the trapezius muscle and the pectoralis minor muscle.
- Posterior surface of the sternocleido mastoid muscle and platysma muscle.
- Ventral surface of the scalene muscle bundle.
- 5 mm caudal to the axillary vein cross medial edge of the pectoralis minor muscle.
- Medial edge of the collar bone and ribs;.
- lateral edge of the junction of the subclavian and internal jugular veins.
- Medial edge of the pectoralis minor muscle.
- Posterior surface of the pectoralis major muscle.
- Axilla level II Cranial edge of the pectoralis minor muscle.
- Caudal edge of the pectoralis minor muscle.
- Lateral edge of the pectoralis minor muscle.
- 5 mm dorsal of the axillary vein, or the ventral edge of the ribs and the intercostal muscle Axilla level I Axillary vein cross.
- lateral edge of the pectoralis minor muscle.
- Medial edge of the latissimus dorsi muscle.
- 5 mm anterior the plane defined by the anterior surface of the pectoralis major muscle and the latissimus dorsi muscle.
- Anterior surface of the subscapularis muscle.
- IMN region 5 mm caudal to the subclavian vein, thus connecting to the caudal border of the.
- Cranial edge of the fourth rib.
- Vx, percent volume of the structure receiving x Gy.
- If the stenosis severity in one of the three main coronary arteries exceeds 50%.
- If the stenosis severity in one of the three main coronary arteries exceeds 75%, revascularization should be performed and the coronary CT angiography examination is scheduled at 3, 6, and 10 years after RT.
- 74% for patients with node-positive breast cancer who did not receive IMNI [11, 17].
- The critical values for the interim analyses will be determined using the Lan–DeMets implementation of the O’Brien–Fleming boundary for interim efficacy analysis and a linear 20% inefficacy boundary for futility analysis [18].
- Before opening inclusion, all participating centers will pro- vide the qualified documents of the QA process of the CT simulator, LINAC, and the RT planning system for general credentialing.
- During inclusion, cen- tral individual case review on the target delineation, RT planning, and treatment position verification data will be performed prospectively for the first 10 patients included at each participating center and an additional 10 patients if major deviation is found in 2 out of the first 10 patients, which then will be performed randomly for 5% of all in- cluded patients thereafter..
- The study protocol has been approved by the ethics committee of the Cancer Hospital, Chinese Academy of Medical Sciences .
- In this report, we present the design of the POTENTIAL trial, which aims to investigate whether IMNI can im- prove DFS in high-risk breast cancer with pN+ after mastectomy.
- Firstly, low- risk patients, such as patients with pN0–1 disease, accounted for a major proportion of the cohort, thus the overestimation of the risk of IMN involvement probably decreased the power of the study.
- RT was performed in the 2-dimensional era, thus the IMN area could have been partially irradiated in some patients in the IMNI group, and protection of the heart could not be performed routinely.
- Considering that most of the patients with pN0 disease do not have indications to re- ceive PMRT, we will only include patients with pN+ dis- ease.
- Patients tend to survive longer after disease relapse because of the rapid development of ef- fective salvage systemic therapy.
- We have developed an oncocardiology service for patients with breast cancer through close cooperation between cardiologists and oncologists.
- QA of non-CT-based IMNI in the DBCG study, using modern techniques to derive esti- mates of the doses to the IMN and OARs, showed that RT techniques utilizing electrons for IMNI had a high degree of IMN dose coverage with little variation in the patient population.
- A dummy run of the QA program in the Korean Radiation Oncology Group 08–06 Study, which is a phase 3 ran- domized trial designed to investigate the role of IMNI in breast cancer, revealed that various 3D RT techniques were adopted among participating institutions, and an average of 59.0% of the prescribed dose was delivered to.
- the IMN in the no IMNI group, which was higher than expected because of the close proximity of the IMN to the medial margin of the chest [34].
- According to our RT QA protocol, we will assess IMN delineation and evaluate the dosimetric parameters of the IMN and OARs.
- In conclusion, the POTENTIAL study is a pragmatic randomized trial that compares survival and toxicity out- comes of delivering IMNI with not delivering postmas- tectomy IMNI in patients with node positive breast cancer.
- DBCG: Danish Breast Cancer Cooperative Group.
- Vx: percent volume of the structure receiving x Gy.
- Drafting of the trial protocol: XRZ.
- Critical revision of the trial protocol for important intellectual content: HF, YT, ZHH, HJ, and LL.
- The funding source has no role in study design, data collection, analysis, interpretation, the writing of the manuscript, or the decision to submit the current study..
- Institutional review board approval was obtained for the POTENTIAL trial from the ethics committee of the Cancer Hospital, Chinese Academy of Medical Sciences (reference number .
- Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy.
- Danish breast Cancer cooperative group 82b trial.
- Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish breast Cancer cooperative group DBCG 82c randomised trial.
- Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer.
- Breast cancer subpopulation with high risk of internal mammary lymph nodes metastasis:.
- analysis of 2,269 Chinese breast cancer patients treated with extended radical mastectomy.
- Breast Cancer Res Treat.
- Internal mammary nodes in breast cancer: diagnosis and implications for patient management.
- Internal mammary lymph node recurrence: rare but characteristic metastasis site in breast cancer.
- The dissection of internal mammary nodes does not improve the survival of breast cancer patients.
- DBCG-IMN: a population-based cohort study on the effect of internal mammary node irradiation in early node-positive breast Cancer.
- Ischemic cardiac events following treatment of the internal mammary nodal region using contemporary radiation planning techniques.
- Validation and modification of a prediction model for acute cardiac events in patients with breast Cancer treated with radiotherapy based on three-dimensional dose distributions to cardiac substructures.
- Deep inspiration breathhold for left-sided breast cancer patients with unfavorable cardiac anatomy requiring internal mammary nodal irradiation.
- Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial.
- Redesigning radiotherapy quality assurance: opportunities to develop an efficient, evidence-based system to support clinical trials--report of the National Cancer Institute work group on radiotherapy quality assurance.
- Does internal mammary node irradiation affect treatment outcome in clinical stage II-III breast cancer patients receiving neoadjuv ant chemotherapy? Breast Cancer Res Treat.
- The role of irradiation of the internal mammary lymph nodes in high-risk stage II to IIIA breast cancer patients after high-dose chemotherapy: a prospective sequential nonrandomized study.
- Internal mammary node irradiation improves 8-year survival in breast cancer patients: results from a retrospective cohort study in real-world setting.
- Breast Cancer.
- Long-term survival outcomes following internal mammary node irradiation in stage II-III breast cancer: results of a large retrospective study with 12-year follow-up.
- Internal mammary node irradiation (IMNI) improves survival outcome for patients with clinical stage II-III breast Cancer after preoperative systemic therapy.
- Internal mammary node irradiation in node-positive breast cancer treated with mastectomy and taxane-based chemotherapy.
- Does the intent to irradiate the internal mammary nodes impact survival in women with breast cancer? A population-based analysis in British Columbia.
- Internal mammary node irradiation neither decreases distant metastases nor improves survival in stage I and II breast cancer.
- Internal mammary nodal irradiation in conservatively- managed breast cancer patients: is there a benefit? Int J Radiat Oncol Biol Phys.
- Effectiveness of the AJCC 8th edition staging system for selecting patients with T1-2N1 breast cancer for post-mastectomy radiotherapy: a joint analysis of 1986 patients from two institutions.
- Estimating the risks of breast Cancer radiotherapy: evidence from modern radiation doses to the lungs and heart and from previous randomized trials..
- Exposure of the heart in breast Cancer radiation therapy: a systematic review of heart doses published during 2003 to 2013.
- Quality assurance of conventional non-CT-based internal mammary lymph node irradiation in a prospective Danish breast Cancer cooperative group trial:.
- Dummy run of quality assurance program in a phase 3 randomized trial investigating the role of internal mammary lymph node irradiation in breast cancer patients:

Xem thử không khả dụng, vui lòng xem tại trang nguồn
hoặc xem Tóm tắt