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Brachytherapy (BT) for locally advanced cervical cancer is vital for optimal outcomes. There is heterogeneity in brachytherapy treatment practice for cervical cancer across India. In an attempt to standardize various processes involved in cervical cancer brachytherapy, the expert members of the Indian Brachytherapy Society (IBS) developed a document related to radiation therapy treatment of cervical cancer with special emphasis on brachytherapy. The guidelines are based on high quality clinical evidence, expert opinion and consensus wherever evidence was lacking. The document provides a guide for external beam radiation and details of all the processes involved in high-dose-rate (HDR) brachytherapy including patient selection, preparation, principles and technique of BT applications, target and normal tissue definition, dose prescriptions, BT planning, reporting parameters, common complications of BT and their management, scope for research, etc. In summary, we present here practical tips and tricks, recording and reporting of cervical cancer brachytherapy, which can be implemented in various clinical environments and forms the basis of this report.

Background: In India, where the annual incidence of cancer is projected to reach 1.7 million by 2020, the need for clinical research to establish the most effective, resource-guided, and evidence-based care is paramount. In this study, we sought to better understand the research training needs of radiation oncologists in India. Methods: A 12 item questionnaire was developed to assess research training needs and was distributed at the research methods course jointly organized by Indian College of Radiation Oncology, the American Brachytherapy Society, and Education Committee of the American Society of Therapeutic Radiation Oncology during the Indian Cancer Congress, 2017. Results: Of 100 participants who received the questionnaire, 63% responded. Ninety percent (56/63) were Radiation Oncologists. Forty-two percent (26/63) of respondents had previously conducted research. A longer length of practice (>10 years) was significantly associated with conducting research (odds ratio (OR) 6.99, P = 0.031) and having formal research training trended toward significance (OR 3.03, P = 0.058). The most common reason for not conducting research was \"lack of training\" (41%, 14/34). The most common types of research conducted were Audits and Retrospective studies (62%, 16/26), followed by a Phase I/II/III Trial (46%, 10/26). Having formal research training was a significant factor associated with writing a protocol (OR 5.53, P = 0.016). Limited training in research methods (54%, 13/24) and lack of mentorship (42%, 10/24) were cited as reasons for not developing a protocol. Ninety-seven percent (57/59) of respondents were interested in a didactic session on research, specifically focusing on biostatistics. Conclusions: With research training and mentorship, there is a greater likelihood that concepts and written protocols will translate into successfully completed studies in radiation therapy.

Purpose Locally advanced (T3/T4) gallbladder cancers with large fixed portal nodes have a dismal prognosis. If undertaken, surgery entails extensive resections with high morbidity; therefore, in many centers, patients are offered palliative chemotherapy. In this prospective study, we used neoadjuvant concurrent chemoradiation with the intention of downstaging and facilitating R0 resection of these tumors. Patients and Methods Twenty-eight patients with locally advanced carcinoma gallbladder (stage III, having deep liver infiltrations and/or large portal nodes) underwent prior positron emission tomography/computed tomography to rule out metastatic disease. All were treated with concomitant chemoradiation using helical tomotherapy (dose of 57 Gy over 25 fractions to the gross tumor and 45 Gy over 25 fractions to the surrounding nodes) with injectable gemcitabine (300 mg/m 2 /week × 5 weeks). Results Of the 28 patients, 25 (89 %) successfully completed planned chemoradiation and 20 (71 %) achieved partial or complete radiologic response. Eighteen (64 %) patients were surgically explored, of whom 14 (56 %) achieved R0 resection. At the median follow-up of 37 months for the surviving patients, the median overall survival (OS) was 20 months for all patients. Only one patient recurred in the common bile duct postsurgery, whereas six patients had distant metastasis. The 5-year OS was 24 % for all patients and 47 % for patients with R0 resection. Biliary leak was seen in 6 (43 %) patients, of whom two required interventions. Conclusion Locally advanced unresectable cancers may benefit from neoadjuvant chemoradiation to facilitate a curative resection with a good survival.

Introduction/BackgroundThe standard treatment for locally advanced vulvar cancer is neodjuvant chemoradiation followed by evaluation for surgery. However a vast majority of patients are yet unable to undergo surgery due to proximity of the tumour to eloquent structures as urethra, post forchette, distal vagina or anal sphincter musclesMethodologyIn our institution, patients with locally advanced vulva cancer are evaluated by examination under anaesthesia for disease mapping prior to initiating chemoradiation. PETCT and/or MRI is performed for staging and colposcopy is performed to exclude simultaneous malignancy in cervix. After chemoradiation a joint examination under anaesthesia is performed by the surgical and radiation oncology team and when patients are deemed surgically resectable interstitial brachytherapy is performed. In each patient the brachytherapy procedure is individualised to ensure target coverage and sparing of adjacent normal structures. This video demonstrates the free hand interstitial technique of a women with locally advanced vulvar cancer with distal vaginal, periurethral involvement. Also disease was close to posterior forchette and clitoris.ResultsFree hand multilane interstitial implant was performed. After external radiation of 45/Gy/25 fractions/5 weeks additional HDR brachytherapy boost of 3.5 Gy x 4 fractions were delivered twice daily. Video demonstrates the complex implant procedure. Additionally aspects of treatment planning and implant removal will be discussed. A summary of techniques of interstitial brachytherapy will be presented. Apart from the case brachytherapy in setting of field cancerisation will also be discussed.ConclusionInterstitial brachytherapy is a highly conformal and effective way of radiation dose escalation in patients with medically inoperable Ca Vulva. Further training of gynecology radiation oncology community is needed to improve outcomes in these cohorts of patients.

Background: For nonmetastatic locally advanced gallbladder cancer (LAGBC) which remains unresectable and nonmetastatic after chemotherapy, there is no consensus on whether to continue chemotherapy or add local radiotherapy (RT) for improving outcomes. Materials and Methods: Forty-five patients of surgically unresectable nonmetastatic LAGBC were analyzed. Twenty patients did not receive RT (no RT cohort) and received only chemotherapy, while 25 patients received RT (RT cohort) with conformal techniques along with concurrent gemcitabine-based chemotherapy. No RT and RT cohorts were compared for disease-related outcomes and toxicities. Results: Median follow-up of the entire cohort was 11.5 months. Two-year progression-free survival (18.6% vs. 0%, P = 0.0001) and overall survival (37.3% vs. 5%, P = 0.0001) were significantly better in the RT cohort as compared to a no RT cohort. More number of patients had locoregional progression in the no RT cohort (85% vs. 32%, P = 0.0002). Radiation-induced acute and late gastrointestinal toxicity ≥ RTOG Grade 3 were seen in one and two patients, respectively. Conclusion: Addition of local RT to chemotherapy improves the survival outcomes and can be considered as a definite treatment modality for nonmetastatic LAGBC patients not amenable to surgery who have responded to chemotherapy.

IntroductionThe revision of International Federation of Gynaecology and Obstetrics staging in 2018 with recommendations to include cross-sectional imaging and a separate stage for node positive disease have opened a lot of uncertainties in implementing the correct treatment approach in these patients. While studies have suggested higher chances of occult para-aortic lymph node (PALN) even with advanced imaging, especially in pelvic node positive disease which tend to recur after pelvic radiation therapy. This study intends to study these patients and isolate the subset who will benefit most from elective PALN irradiation.Methods and analysisThis is an ongoing multicentric phase III randomised controlled trial with a sample size of 274 subjects in two arms (137 in each arm) to determine the superiority of limited elective para-aortic irradiation compared with no irradiation. Arm one includes radiation to the lower PALN and pelvis; Arm two includes radiation to the pelvis. Concurrent chemotherapy followed by brachytherapy is standard in both arms. Patients with cervical cancer and radiologically positive pelvic LNs aged>18 years and<70 years are screened for the study. The primary endpoint of this study is 3-year disease-free survival. The secondary endpoints include 3-year para-aortic recurrence-free survival, 3-year distant metastasis-free survival, 3-year overall survival, acute and late toxicity, quality of life. Translational study to evaluate systemic immune response by FAPI-PETCT (fibroblast activator protein inhibitor positron emission tomography) and assessment of p16, L1 cell adhesion molecule (L1CAM) and protein death ligand-1 (PDL-1) expression by immunohistochemistry.Ethics and disseminationThe study has been approved by the institutional ethics committee and will be routinely monitored according to standard guidelines. The results of the study will be published in peer-reviewed scientific journals, presented at conferences and submitted to regulatory authorities.Trial registration numberThe study was registered on 17 January 2022 under CTRI/2022/01/039495 (http://ctri.nic.in).

IntroductionIn locally advanced cervical cancer, nodal, local and distant relapse continue to be significant patterns of relapse. Therefore, strategies to improve the efficacy of chemoradiation are desirable such as biological pathway modifiers and immunomodulating agents. This trial will investigate the impact of nelfinavir, a protease inhibitor that targets the protein kinase B (AKT) pathway on disease-free survival (DFS).Methods and analysisRadiosensitising effect of nelfinavir in locally advanced carcinoma of cervix is a single-centre, open-label, parallel-group, 1:1 randomised phase-III study. Patients aged over 18 years with a diagnosis of carcinoma cervix stage III are eligible for the study. After consenting, patients will undergo randomisation to chemoradiation and brachytherapy arm or nelfinavir with chemoradiation and brachytherapy arm. The primary aim of the study is to compare the difference in 3-year DFS between the two arms. Secondary aims are locoregional control, overall survival, toxicity and quality of life between the two arms. Pharmacokinetics of nelfinavir and its impact on tumour AKT, programmed cell death ligand 1, cluster of differentiation 4, cluster of differentiation 8 and natural killer 1.1 expression will be investigated. The overall sample size of 348 with 1 planned interim analysis achieves 80% power at a 0.05 significance level to detect a HR of 0.66 when the proportion surviving in the control arm is 0.65. The planned study duration is 8 years.Ethics and disseminationThe trial is approved by the Institutional Ethics Committee-I of Tata Memorial Hospital, Mumbai (reference number: IEC/0317/1543/001) and will be monitored by the data safety monitoring committee. The study results will be disseminated via peer-reviewed scientific journals, and conference presentations. Study participants will be accrued after obtaining written informed consent from them. The confidentiality and privacy of study participants will be maintained.Trial registration numberThe trial is registered with Clinical Trials Registry-India (CTRI/2017/08/009265) and ClinicalTrials.gov (NCT03256916).

Aim To investigate the potential role of a novel spatially fractionated radiation therapy (SFRT) method where heterogeneous dose patterns are created in target areas with virtual rods, straight or curving, of variable position, diameter, separation and alignment personalised to a patient’s anatomy. The images chosen for this study were CT scans acquired for the external beam part of radiotherapy. Methods Ten patients with locally advanced cervical cancer were retrospectively investigated with SFRT. The dose prescription was 30 Gy in 5 fractions to 90% target volume coverage. Peak-and-valley (SFRT_1) and peak-only (SFRT_2) strategies were applied to generate the heterogeneous dose distributions. The planning objectives for the target (CTV) were D 90%  ≥ 30 Gy, V 45Gy  ≥ 50–55% and V 60Gy  ≥ 30%. The planning objectives for the organs at risk (OAR) were: D 2cm3  ≤ 23.75 Gy, 17.0 Gy, 19.5 Gy, 17.0 Gy for the bladder, rectum, sigmoid and bowel, respectively. The plan comparison was performed employing the quantitative analysis of the dose-volume histograms. Results The D 2cm3 was 22.4 ± 2.0 (22.6 ± 2.1) and 13.9 ± 2.9 (13.2 ± 3.0) for the bladder and the rectum for SFRT_1 (SFRT_2). The results for the sigmoid and the bowel were 2.6 ± 3.1 (2.8 ± 3.0) and 9.1 ± 5.9 (9.7 ± 7.3), respectively. The hotspots in the target volume were V 45Gy  = 43.1 ± 7.5% (56.6 ± 5.6%) and V 60Gy  = 15.4 ± 5.6% (26.8 ± 6.6%) for SFRT_1 (SFRT_2). To account for potential uncertainties in the positioning, the dose prescription could be escalated to D 90%  = 33–35 Gy to the CTV without compromising any constraints to the OARs Conclusion In this dosimetric study, the proposed novel planning technique for boosting the cervix uteri was associated with high-quality plans, respecting constraints for the organs at risk and approaching the level of dose heterogeneity achieved with routine brachytherapy. Based on a sample of 10 patients, the results are promising and might lead to a phase I clinical trial.

Brachytherapy plays a critical role in managing gynecological cancers. However, for patients who have a poor response to chemoradiation or present with complex anatomy, delivering tumoricidal doses may be challenging. In this case series, we present a descriptive narrative of techniques adopted for brachytherapy, dosimetric and early clinical outcomes for such clinical challenging cases. Patients who had a poor response to chemoradiation or with challenging anatomy received individualized brachytherapy between 2021 and 2023. All underwent pre-brachytherapy clinical assessment and MRI. These patients were treated with personalized brachytherapy techniques based on tumor extent and anatomy. Manual dose optimization and adjustments to dose fractionation were tailored on a case-by-case basis maximizing tumor control and limiting organ-at-risk doses. In the six patients included in this report, the median high-risk clinical target volume (HR-CTV) volume was 51.1 cc. For each patient, the implant was individualized using a combination of applicators, 3D-printed applicators or freehand needles. At a median follow-up of 31 months, three out of six patients were locally controlled. Out of the three patients with locally controlled disease, one patient developed grade 2 posterior fourchette necrosis. Though the results provide a descriptive narrative, they also highlight a clinical care gap that brachytherapy alone cannot yet address for patients. Advancing individualized brachytherapy by incorporating novel agents and techniques may help improve treatment outcomes.

Treatment of isolated post-surgical vault recurrence of cervical and endometrial cancers in previously unirradiated patients includes external beam radiotherapy (EBRT) ± concomitant chemotherapy, followed by brachytherapy (BT) boost. Supra-vaginal component of vault disease often requires interstitial BT for optimal dose coverage. We describe technical details and preliminary case series using modified Houdek vault applicator (MHVA) developed at our institution for limited intra-cavitary plus interstitial high-dose-rate (HDR) vault BT. Nineteen patients with vaginal vault recurrences received BT boost with MHVA between October 2015 and May 2018. All underwent BT application and CT-based BT planning after completion of EBRT ± concomitant chemotherapy. Median EQD of BT dose in patients with carcinoma cervix recurrence ( = 15, α/β = 10) was 18.8 Gy, and in those with endometrial cancer recurrence was 22.08 Gy ( = 4, α/β = 4.5). Median total EQD was 68.8 Gy and 72.08 Gy, respectively. Mean 2 cc of bladder, rectum, and sigmoid EBRT + BT doses (EQD , α/β = 3) were 65.38 Gy (±7.76), 63.37 Gy (±5.52), and 57.04 Gy (±4.45), respectively. At 6-8 weeks, 17 patients showed complete response (CR). With median follow-up of 20.5 months, 2-year overall survival was 95% (95% CI: 85.2-100.0%), and 2-year progression-free survival was 79.4% (95% CI: 61.0-97.8%). Late toxicities seen were grade 2 proctitis in 1 patient, grade 1 proctitis in 5, grade 2 urethritis in 1, grade 3 cystitis in 1, and recto-vaginal fistula in 1 patient (with disease controlled). Recurrence rate was 6.7 times higher in patients with post-EBRT disease greater than 10 mm ( = 0.01). MHVA is a simple solution for intra-cavitary and interstitial HDR-BT boost in isolated vault cancers post-surgery, achieving acceptable dosimetric parameters. Preliminary clinical outcomes and late toxicities are satisfactory.