Phase 1/2 trial evaluating the effectiveness and safety of dose-adapted Hypofractionated pelvic radiotherapy for Advanced Cervical cancers INeligible for ChemoTherapy (HYACINCT)

Bacorro, Warren; Baldivia, Kathleen; Dumago, Mark P.; Bojador, Maureen; Milo, Abigail; Trinidad, Celestine; Mariano, Jocelyn; Gonzalez, Gil; Ortin, Teresa Sy

doi:10.1080/0284186x.2022.2048070

Cited by 5 publications

(7 citation statements)

References 34 publications

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“…Another trial, known as the HYACINCT (Hypofractionated Pelvic Radiotherapy for Advanced Cervical Cancers Ineligible for Chemotherapy) trial, is investigating the safety of hypofractionated pelvic RT (administered at a dose of 2.37 Gy per fraction for a total of 15 fractions) for treatment of patients with advanced cervical cancer. 20 The safety of hypofractionated RT in the pelvic area has always been doubtful due to concerns about bowel toxic effects. However, evidence regarding bowel tolerance in hypofractionation regimens is limited.…”

Section: Discussionmentioning

confidence: 99%

Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer

Cho,

Park,

Kim

et al. 2024

JAMA Oncol

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ImportanceProspective data assessing the safety of hypofractionated (40 Gy in 16 fractions) radiotherapy (RT) among patients who receive postoperative concurrent chemoradiotherapy for cervical cancer are lacking.ObjectiveTo evaluate the acute toxic effects of hypofractionated pelvic intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy among women with cervical cancer who underwent radical hysterectomy.Design, Setting, and ParticipantsThe POHIM-CCRT (Postoperative Hypofractionated Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer) study was designed as a multicenter, phase 2 nonrandomized controlled trial that accrued and followed up patients from June 1, 2017, to February 28, 2023. In total, 84 patients were enrolled from 5 institutions affiliated with the Korean Radiation Oncology Group. Eligible patients experienced lymph node metastasis, parametrial invasion, or positive resection margins after radical hysterectomy for treatment of confirmed cervical cancer.InterventionPostoperative pelvic radiation using hypofractionated IMRT with 40 Gy in 16 fractions to the whole pelvis combined with concurrent chemotherapy.Main Outcomes and MeasuresThe primary end point was incidence of acute grade 3 or higher gastrointestinal tract, genitourinary, and hematologic toxic effects (based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0) in the evaluable population during RT or within 3 months after RT completion.ResultsOf 84 patients enrolled, 5 dropped out prior to RT, and data from 79 patients were analyzed. The patients’ median (IQR) age was 48 (42-58) years, and the median (IQR) tumor size was 3.7 (2.7-4.5) cm. Of these patients, 31 (39.7%) had lymph node metastasis, 4 (5.1%) had positive resection margins, and 43 (54.4%) had parametrial invasion. Grade 3 or higher acute toxic effects occurred in 2 patients (2.5% [90% CI, 0%-4.8%]). After a median (IQR) follow-up of 43.0 (21.1-59.0) months, the 3-year disease-free survival rate was 79.3%, and the overall survival rate was 98.0%.ConclusionsFindings from this nonrandomized control trial indicated that postoperative pelvic irradiation combined with concurrent chemotherapy using hypofractionated IMRT with 40 Gy in 16 fractions was safe and well-tolerated in women with cervical cancer. Studies assessing long-term toxic effects and oncological outcomes with longer follow-up periods are needed.Trial RegistrationClinicalTrials.gov Identifier: NCT03239613

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Section: Discussionmentioning

confidence: 99%

Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer

Cho,

Park,

Kim

et al. 2024

JAMA Oncol

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“…At present, the option exists to reduce the number of BATD sessions [ 46 ] but at the teletherapy level, it is not recommended to use hypofractionation in order to reduce the number of sessions as in other pathologies [ 8 , 17 ]. However, the future option exists to offer hypofractionation of 15 sessions followed by 4 BATD applications in women with CT contraindications such as advanced illness with secondary renal dysfunction and hydronephrosis related to the tumour, borderline cardiac function; and fragile patients [ 47 ]. Similarly, by means of phase II trials NCT04070976 and NCT04583254, the efficacy and safety of hypofractionated doses are studied in CTRT.…”

Section: Discussionmentioning

confidence: 99%

Cost analysis of three-dimensional radiation therapy versus intensitymodulated chemoradiotherapy for locally advanced cervical cancer in Peruvian citizens

Díaz¹

2023

ecancer

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Background and objectives:The standard treatment for locally advanced cervical cancer (CC) is chemoradiotherapy (CTRT) followed by high-dose-rate brachytherapy (HDRBT). The ideal scenario would be under novel intensity-modulated radiation therapy (IMRT) volumetric-modulated arc therapy (VMAT) radiation techniques over three-dimensional (3D) radiation therapy. However, radiotherapy (RT) centres in low-and middle-income countries have limited equipment for teletherapy services like HDRBT. This is why the 3D modality is still in use. The objective of this study was to analyse costs in a comparison of 3D versus IMRT versus VMAT based on clinical staging. Materials and methods:From 02/01/2022 to 05/01/2023 a prospective registry of the costs for oncological management was carried out for patients with locally advanced CC who received CTRT ± HDRBT. This included the administration of radiation with chemotherapy. The cost associated with patient and family transfers and hours in the hospital was also identified. These expenses were used to project the direct and indirect costs of 3D versus IMRT versus VMAT. Results:The treatment regimens for stage IIIC2, including 3D and novel techniques, are those with the highest costs.

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“…The instrument could be used in the clinical evaluation of and in clinical research on Filipino prostate cancer patients. Further, its gastrointestinal and genitourinary domains could be used in clinical research on Filipino patients with other pelvic, such as gynecologic, malignancies (NCT05210270) 9 …”

Section: Discussionmentioning

confidence: 99%

“…A psychometrically tested Filipino version of the EPIC‐32 will be a useful tool in the clinical assessment of Filipino prostate cancer patients, and in clinical research towards evaluation and improvement of treatment options. Furthermore, its urinary and bowel domains could also be used in research on other pelvic malignancies among Filipino patients (NCT05210270) 9 …”

Section: Introductionmentioning

confidence: 99%

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Development and pilot‐testing of the expanded prostate index composite – Filipino version (EPIC‐F)

Bacorro

Tordesillas

Dumago

et al. 2022

Asia-Pac J Clncl Oncology

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Introduction: Quality-of-life (QOL) is paramount in clinical decision-making in the management of prostate cancer patients. The expanded prostate index composite (EPIC) is a widely used and well-validated QOL tool that allows for the evaluation of bowel, urinary, sexual, and hormonal domains. A Filipino translation was previously lacking. We describe the development and pilot testing of the Filipino translation of the EPIC (EPIC-F). Methodology:The EPIC-32 was translated into Filipino using iterative forward and backward procedures with checks for semantic congruency. The translation was then evaluated by an expert panel consisting of a prostate cancer survivor and pertinent health professionals. A focused group discussion (FGD) was conducted to explore sources of difficulty of use to guide improvement. Results:The linguistically validated translation was evaluated to have cultural relevancy, adequacy, and representativeness by the expert panel, and to have good understandability and answerability by a representative pilot cohort of prostate cancer patients. Seven unsatisfactory items were identified, all pertaining to the sexual domain, and required minimal revision on review during the FGD. Conclusion:The EPIC-F is a linguistically and culturally validated version of the EPIC 32, with good understandability and answerability, permitting clinical use. Its psychometric properties need to be determined to define its utility in clinical research.

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Phase 1/2 trial evaluating the effectiveness and safety of dose-adapted Hypofractionated pelvic radiotherapy for Advanced Cervical cancers INeligible for ChemoTherapy (HYACINCT)

Cited by 5 publications

References 34 publications

Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer

Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer

Cost analysis of three-dimensional radiation therapy versus intensitymodulated chemoradiotherapy for locally advanced cervical cancer in Peruvian citizens

Development and pilot‐testing of the expanded prostate index composite – Filipino version (EPIC‐F)

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