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Whole-breast irradiation after breast-conserving surgery for patients with early-stage breast cancer decreases ipsilateral breast-tumour recurrence (IBTR), yielding comparable results to mastectomy. It is unknown whether accelerated partial breast irradiation (APBI) to only the tumour-bearing quadrant, which shortens treatment duration, is equally effective. In our trial, we investigated whether APBI provides equivalent local tumour control after lumpectomy compared with whole-breast irradiation. We did this randomised, phase 3, equivalence trial (NSABP B-39/RTOG 0413) in 154 clinical centres in the USA, Canada, Ireland, and Israel. Adult women (>18 years) with early-stage (0, I, or II; no evidence of distant metastases, but up to three axillary nodes could be positive) breast cancer (tumour size ≤3 cm; including all histologies and multifocal breast cancers), who had had lumpectomy with negative (ie, no detectable cancer cells) surgical margins, were randomly assigned (1:1) using a biased-coin-based minimisation algorithm to receive either whole-breast irradiation (whole-breast irradiation group) or APBI (APBI group). Whole-breast irradiation was delivered in 25 daily fractions of 50 Gy over 5 weeks, with or without a supplemental boost to the tumour bed, and APBI was delivered as 34 Gy of brachytherapy or 38·5 Gy of external bream radiation therapy in 10 fractions, over 5 treatment days within an 8-day period. Randomisation was stratified by disease stage, menopausal status, hormone-receptor status, and intention to receive chemotherapy. Patients, investigators, and statisticians could not be masked to treatment allocation. The primary outcome of invasive and non-invasive IBTR as a first recurrence was analysed in the intention-to-treat population, excluding those patients who were lost to follow-up, with an equivalency test on the basis of a 50% margin increase in the hazard ratio (90% CI for the observed HR between 0·667 and 1·5 for equivalence) and a Cox proportional hazard model. Survival was assessed by intention to treat, and sensitivity analyses were done in the per-protocol population. This trial is registered with ClinicalTrials.gov, NCT00103181. Between March 21, 2005, and April 16, 2013, 4216 women were enrolled. 2109 were assigned to the whole-breast irradiation group and 2107 were assigned to the APBI group. 70 patients from the whole-breast irradiation group and 14 from the APBI group withdrew consent or were lost to follow-up at this stage, so 2039 and 2093 patients respectively were available for survival analysis. Further, three and four patients respectively were lost to clinical follow-up (ie, survival status was assessed by phone but no physical examination was done), leaving 2036 patients in the whole-breast irradiation group and 2089 in the APBI group evaluable for the primary outcome. At a median follow-up of 10·2 years (IQR 7·5–11·5), 90 (4%) of 2089 women eligible for the primary outcome in the APBI group and 71 (3%) of 2036 women in the whole-breast irradiation group had an IBTR (HR 1·22, 90% CI 0·94–1·58). The 10-year cumulative incidence of IBTR was 4·6% (95% CI 3·7–5·7) in the APBI group versus 3·9% (3·1–5·0) in the whole-breast irradiation group. 44 (2%) of 2039 patients in the whole-breast irradiation group and 49 (2%) of 2093 patients in the APBI group died from recurring breast cancer. There were no treatment-related deaths. Second cancers and treatment-related toxicities were similar between the two groups. 2020 patients in the whole-breast irradiation group and 2089 in APBI group had available data on adverse events. The highest toxicity grade reported was: grade 1 in 845 (40%), grade 2 in 921 (44%), and grade 3 in 201 (10%) patients in the APBI group, compared with grade 1 in 626 (31%), grade 2 in 1193 (59%), and grade 3 in 143 (7%) in the whole-breast irradiation group. APBI did not meet the criteria for equivalence to whole-breast irradiation in controlling IBTR for breast-conserving therapy. Our trial had broad eligibility criteria, leading to a large, heterogeneous pool of patients and sufficient power to detect treatment equivalence, but was not designed to test equivalence in patient subgroups or outcomes from different APBI techniques. For patients with early-stage breast cancer, our findings support whole-breast irradiation following lumpectomy; however, with an absolute difference of less than 1% in the 10-year cumulative incidence of IBTR, APBI might be an acceptable alternative for some women. National Cancer Institute, US Department of Health and Human Services.

Background Isolated local failure (ILF) can occur in patients who initially receive definitive radiation therapy for prostate cancer. Salvage therapy for ILF includes high dose rate (HDR) brachytherapy. Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) can accurately detect ILF and can exclude extraprostatic disease. Lutetium-177 PSMA Radioligand Therapy (RLT) is a novel treatment for prostate cancer that can target prostate cancer accurately, while sparing radiation dose to normal tissues. Methods ROADSTER is a phase I/II randomized, single-institution study. Patients with an ILF of prostate cancer after definitive initial radiation therapy are eligible. The ILF will be confirmed with biopsy, magnetic resonance imaging (MRI) and PSMA PET. Patients will be randomized between HDR brachytherapy in two fractions (a standard of care salvage treatment at our institution) (cohort 1) or one treatment of intravenous Lutetium-177 PSMA RLT, followed by one fraction of HDR brachytherapy (cohort 2). The primary endpoints for the phase I portion of the study (n = 12) will be feasibility, defined as 10 or more patients completing the study protocol within 24 months of study activation; and safety, defined as zero or one patients in cohort 2 experiencing grade 3 or higher toxicity in the first 6 months post-treatment. If feasibility and safety are achieved, the study will expand to a phase II study (n = 30 total) where preliminary efficacy data will be evaluated. Secondary endpoints include changes in prostate specific antigen levels, acute toxicity, changes in quality of life, and changes in translational biomarkers. Translational endpoints will include interrogation of blood, urine, and tissue for markers of DNA damage and immune activation with each treatment. Discussion ROADSTER explores a novel salvage therapy for ILF after primary radiotherapy with combined Lutetium-177 PSMA RLT and HDR brachytherapy. The randomized phase I/II design will provide a contemporaneous patient population treated with HDR alone to facilitate assessment of feasibility, tolerability, and biologic effects of this novel therapy. Trial registration NCT05230251 (ClinicalTrials.gov).

Purpose This study aimed to evaluate the effects of acupressure on pain, anxiety, depression, and physiological parameters in women undergoing brachytherapy for gynecological cancer. Methods The research was conducted between December 2023 and September 2024 using a randomized controlled design. All patients receiving brachytherapy were randomly assigned to the acupressure group ( n  = 40) or the control group ( n  = 40). In addition to standard clinical care, the acupressure group received manual acupressure for 30 min before each brachytherapy session at specific acupressure points (SP6, PC6, LI4, HT7, LV4). The data were collected using the Personal Information Form, Visual Analog Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Hospital Anxiety and Depression Scale (HADS), and Vital Signs Form. Results The groups were comparable in terms of sociodemographic and clinical characteristics ( p  > 0.05). Significant reductions were observed in anxiety, depression, and pain levels in the acupressure group at post-test compared to baseline and the control group ( p  < 0.001). Additionally, diastolic blood pressure and body temperature significantly decreased in the intervention group ( p  < 0.001), whereas no significant differences were found for pulse and respiratory rate ( p  > 0.05). Conclusion The results obtained from this study suggest that acupressure may be a beneficial complementary method for reducing anxiety, depression, and pain, as well as contributing to the regulation of certain physiological parameters in patients undergoing brachytherapy. These findings indicate that acupressure could be considered an intervention that may be integrated into clinical practice to support psychological and physiological well-being. Trial registration NCT06531551. Date of Registration: 1 August 2024.

Whole breast irradiation delivered once per day over 3–5 weeks after breast conserving surgery reduces local recurrence with good cosmetic results. Accelerated partial breast irradiation (APBI) delivered over 1 week to the tumour bed was developed to provide a more convenient treatment. In this trial, we investigated if external beam APBI was non-inferior to whole breast irradiation. We did this multicentre, randomised, non-inferiority trial in 33 cancer centres in Canada, Australia and New Zealand. Women aged 40 years or older with ductal carcinoma in situ or node-negative breast cancer treated by breast conserving surgery were randomly assigned (1:1) to receive either external beam APBI (38·5 Gy in ten fractions delivered twice per day over 5–8 days) or whole breast irradiation (42·5 Gy in 16 fractions once per day over 21 days, or 50 Gy in 25 fractions once per day over 35 days). Patients and clinicans were not masked to treatment assignment. The primary outcome was ipsilateral breast tumour recurrence (IBTR), analysed by intention to treat. The trial was designed on the basis of an expected 5 year IBTR rate of 1·5% in the whole breast irradiation group with 85% power to exclude a 1·5% increase in the APBI group; non-inferiority was shown if the upper limit of the two-sided 90% CI for the IBTR hazard ratio (HR) was less than 2·02. This trial is registered with ClinicalTrials.gov, NCT00282035. Between Feb 7, 2006, and July 15, 2011, we enrolled 2135 women. 1070 were randomly assigned to receive APBI and 1065 were assigned to receive whole breast irradiation. Six patients in the APBI group withdrew before treatment, four more did not receive radiotherapy, and 16 patients received whole breast irradiation. In the whole breast irradiation group, 16 patients withdrew, and two more did not receive radiotherapy. In the APBI group, a further 14 patients were lost to follow-up and nine patients withdrew during the follow-up period. In the whole breast irradiation group, 20 patients were lost to follow-up and 35 withdrew during follow-up. Median follow-up was 8·6 years (IQR 7·3–9·9). The 8-year cumulative rates of IBTR were 3·0% (95% CI 1·9–4·0) in the APBI group and 2·8% (1·8–3·9) in the whole breast irradiation group. The HR for APBI versus whole breast radiation was 1·27 (90% CI 0·84–1·91). Acute radiation toxicity (grade ≥2, within 3 months of radiotherapy start) occurred less frequently in patients treated with APBI (300 [28%] of 1070 patients) than whole breast irradiation (484 [45%] of 1065 patients, p<0·0001). Late radiation toxicity (grade ≥2, later than 3 months) was more common in patients treated with APBI (346 [32%] of 1070 patients) than whole breast irradiation (142 [13%] of 1065 patients; p<0·0001). Adverse cosmesis (defined as fair or poor) was more common in patients treated with APBI than in those treated by whole breast irradiation at 3 years (absolute difference, 11·3%, 95% CI 7·5–15·0), 5 years (16·5%, 12·5–20·4), and 7 years (17·7%, 12·9–22·3). External beam APBI was non-inferior to whole breast irradiation in preventing IBTR. Although less acute toxicity was observed, the regimen used was associated with an increase in moderate late toxicity and adverse cosmesis, which might be related to the twice per day treatment. Other approaches, such as treatment once per day, might not adversely affect cosmesis and should be studied. Canadian Institutes for Health Research and Canadian Breast Cancer Research Alliance.

Brachytherapy is a specific form of radiotherapy consisting of the precise placement of radioactive sources directly into or next to the tumor. This technique is indicated for patients affected by various types of cancers. It is an optimal tool for delivering very high doses to the tumor focally while minimizing the probability of normal tissue complications. Physicians from a wide range of specialties may be involved in either the referral to or the placement of brachytherapy. Many patients require brachytherapy as either primary treatment or as part of their oncologic care. On the basis of high‐level evidence from randomized controlled trials, brachytherapy is mainly indicated: 1) as standard in combination with chemoradiation in patients with locally advanced cervical cancer; 2) in surgically treated patients with uterine endometrial cancer for decreasing the risk of vaginal vault recurrence; 3) in patients with high‐risk prostate cancer to perform dose escalation and improve progression‐free survival; and 4) in patients with breast cancer as adjuvant, accelerated partial breast irradiation or to boost the tumor bed. In this review, the authors discuss the clinical relevance of brachytherapy with a focus on indications, levels of evidence, and results in the overall context of radiation use for patients with cancer.

The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer. We aimed to further assess the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer. In this multicentre, single-blind, randomised, phase 3 trial, we enrolled patients with unresectable oesophageal cancer from 16 hospitals in China. We included adult patients (aged ≥ 20 years) with progressive dysphagia, unresectable tumours due to extensive lesions, metastases, or poor medical condition, and with clear consciousness, cooperation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. Eligible patients were randomly assigned (in 1:1 ratio, no stratification) to receive either a stent loaded with (125)iodine radioactive seeds (irradiation group) or a conventional oesophageal stent (control group). The primary endpoint was overall survival. Survival analyses were done in a modified intention-to-treat group. This study is registered with ClinicalTrials.gov, number NCT01054274. Between Nov 1, 2009, and Oct 31, 2012, 160 patients were randomly assigned to receive treatment with either an irradiation stent (n=80) or a conventional stent (n=80). During a median follow-up of 138 days (IQR 72-207), 148 stents (73 in the irradiation group and 75 in the control group) were successfully placed into the diseased oesophagus in 148 participants. Median overall survival was 177 days (95% CI 153-201) in the irradiation group versus 147 days (124-170) in the control group (p=0.0046). Major complications and side-effects of the treatment were severe chest pain (17 [23%] of 73 patients in the irradiation group vs 15 [20%] of 75 patents in the control group), fistula formation (six [8%] vs five [7%]), aspiration pneumonia (11 [15%] vs 14 [19%]), haemorrhage (five [7%] vs five [7%]), and recurrent dysphagia (21 [28%] vs 20 [27%]). In patients with unresectable oesophageal cancer, the insertion of an oesophageal stent loaded with (125)iodine seeds prolonged survival when compared with the insertion of a conventional covered self-expandable metallic stent.

To determine the safety and effectiveness of ultrasound-guided paracervical nerve blocks for the painless treatment of patients with cervical cancer post-implantation. Single-center randomized controlled trial. Fourth Hospital of Hebei Medical University (July 2023 to October 2023). ChiCTR2300071580 [https://clin.larvol.com/trial-detail/ChiCTR2300071580]. Eighty patients with cervical cancer underwent post-implantation treatment. Patients receiving and not receiving paracervical nerve blocks (Groups T and C, respectively) were randomly allocated. Primary measures included visual analog scale (VAS) scores and patient body movement scores at various stages, including vaginal speculum placement (T1), applicator/needle insertion (T2), treatment administration following connection of the treatment tube (T3), needle withdrawal and hemostasis (T4), and willingness to receive further treatment. The secondary observation indices in this study included the operation time, incidence of hypoxemia, occurrence of nausea and vomiting, adverse events related to the circulatory system, patient satisfaction score, operator satisfaction score, and operation duration required by patients with an Alderte score of ≥ 9. Forty patients each were randomly allocated into Groups T and C. The VAS scores did not differ significantly between the two groups at T1. However, at T3 and T4, the VAS scores of Group T was significantly lower than that of Group C. No significant difference was observed in the body movement scores between the two groups at T1 and T3. However, the body movement score of Group T was significantly lower than that of Group C (P < 0.001) at T2 and T4. Group T showed higher postoperative satisfaction and willingness to receive further treatment compared to that of Group C. Ultrasound-guided paracervical nerve block effectively reduced the pain scores in patients with cervical cancer undergoing post-implantation treatment and enhanced their inclination to undergo further treatment.

Objective To evaluate the clinical value of real‑time transrectal ultrasound (TRUS) guidance in interstitial brachytherapy (ISBT) for patients with vaginal stump recurrence after hysterectomy for cervical cancer. Methods This retrospective, non-randomized study included 32 patients receiving ISBT who were categorized into two groups: Group A (TRUS‑guided ISBT, n=16) and Group B (non‑TRUS‑guided ISBT, n=16). A total of 39 procedures were performed in Group A, involving 137 implanted interstitial needles, while Group B underwent 37 procedures with 145 needles implanted. Postoperative computed tomography (CT) was used to evaluate vaginal stump unintended perforation rates, penetration depth, and rectal or bladder perforation. Results A total of 282 interstitial needles were implanted across both groups.The vaginal stump unintended perforation rate in Group A was significantly lower than in Group B (16.06% vs. 40.69%, P < 0.05). Furthermore, In Group A, 22 (22/137) needles perforated the vaginal stump, with a mean penetration depth of 3.36 ± 1.32 mm, while in Group B, 59 (59/145) needles perforated the vaginal stump, with a mean penetration depth of 5.29 ± 3.51 mm; The mean penetration depth in Group A was significantly lower than that in Group B (t = -3.576; P < 0.05). Additionally, the incidence of rectal and bladder perforation was significantly lower in Group A compared to Group B (2.92% vs. 12.41%, P < 0.05). Conclusion The use of TRUS guidance in ISBT for vaginal stump recurrence significantly reduces the incidence and depth of unintended perforations and is anticipated to lower the risk of fistula formation. These findings support TRUS as a promising technique for enhancing the safety of ISBT in patients with recurrent cervical cancer.

Purpose This randomized controlled study was conducted to analyze the effect of hand massage on the fatigue level of the women receiving brachytherapy. Methods It was determined that 12 patients were included in each group (control and hand massage group), so 24 women with gynecologic cancer were included in the study. The application was performed on each hand for 5 min, a total of 10 min in hand massage group. Hand massage was applied before each brachytherapy (at the first, second, and third sessions, a total of three times) every other day for 1 week in the hand massage group. No intervention was performed to the control group during the study. The data were collected using the Patient Information Form and Brief Fatigue Inventory (BFI). Results At the end of the brachytherapy, the fatigue severity score and impact of fatigue on activities of daily living scores of the group that applied hand massage were determined to be lower than the control group ( p  < 0.05). Conclusion It was determined that hand massage effectively controlled fatigue and the impact of fatigue on activities of daily living. Hand massage is a safe and economical method that can be performed by certified nurses. Trial registration This clinical trial is registered at ClinicalTrials.gov (NCT06056713-09/21/2023).

Background The multicentre randomised SPARC trial evaluated the efficacy of a nurse-led sexual rehabilitation intervention on sexual functioning, distress, dilator use, and vaginal symptoms after radiotherapy for gynaecological cancers. Methods Eligible women were randomised to the rehabilitation intervention or care-as-usual. Four intervention sessions were scheduled over 12 months, with concurrent validated questionnaires and clinical assessments. Primary outcome was the Female Sexual Function Index (FSFI). A generalised-mixed-effects model compared groups over time. Results In total, 229 women were included ( n  = 112 intervention; n  = 117 care-as-usual). No differences in FSFI total scores were found between groups at any timepoint ( P  = 0.37), with 12-month scores of 22.57 (intervention) versus 21.76 (care-as-usual). The intervention did not significantly improve dilator use, reduce sexual distress or vaginal symptoms compared to care-as-usual. At 12 months, both groups had minimal physician-reported vaginal stenosis; 70% of women were sexually active and reported no or mild vaginal symptoms. After radiotherapy and brachytherapy, 85% (intervention) versus 75% (care-as-usual) of participants reported dilation twice weekly. Discussion Sexual rehabilitation for women treated with combined (chemo)radiotherapy and brachytherapy improved before and during the SPARC trial, which likely contributed to comparable study groups. Best practice involves a sexual rehabilitation appointment 1 month post-radiotherapy, including patient information, with dilator guidance, preferably by a trained nurse, and follow-up during the first year after treatment. Clinical trial registration NCT03611517.