1.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
2.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
3.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
4.Giant Cell Tumor of the Proximal Femur: Clinical Outcomes of Curettage
Sang Hyun CHO ; Chang-Bae KONG ; Wan-Hyeong CHO ; Dae-Geun JEON ; Hyo Dong OH ; Won Seok SONG
The Journal of the Korean Orthopaedic Association 2024;59(3):201-207
Purpose:
Giant cell tumor (GCT) of the proximal femur is relatively rare, with only a few case series reported thus far. This study aimed to evaluate the clinical outcomes of GCT of the proximal femur treated with intralesional curettage and expand the understanding of their characteristics and treatment considerations.
Materials and Methods:
Fifteen cases treated with curettage for GCT of the proximal femur between 2007 and 2020 were reviewed. The median follow-up was 46 months (25–150 months). There were 10 males and 5 females with a median age of 26 years (17–71 years). After curettage, the bone defect was filled with either an allograft (7 cases) or bone cement (8 cases).
Results:
The postoperative complications were local recurrences in three cases (20.0%), including malignant transformation in one case and a femur neck fracture in one case (6.7%) following curettage and strut allograft. Among the 15 cases, 13 (86.7%) retained their native joint at the last follow-up. No patients developed degenerative changes or osteonecrosis.
Conclusion
The results of proximal femoral GCT with curettage were acceptable despite local recurrences in three cases (20.0%), and femur neck fracture in one case. An appropriate surgical approach and reconstruction according to the extent of the lesion are necessary for successful treatment.
5.Proximal Femur Salvage in Revision Knee Arthroplasty Due to Oncologic Indications:Long-term Results of Onlay and Overlapping Allograft in Revision Surgeries
Sanghyun CHO ; Dae-Geun JEON ; Wan Hyeong CHO ; Won Seok SONG ; Yongsung KIM
Clinics in Orthopedic Surgery 2023;15(5):853-863
Background:
Mechanical failures of tumor endoprosthesis in the distal femur usually require revision surgery. We investigated if the proximal femur host bone can be salvaged by onlay and overlapping allograft in revision surgeries due to aseptic loosening and stem fractures.
Methods:
We retrospectively reviewed 18 patients (7 men and 11 women) with osteosarcoma around the knee. The entire cohort was classified into three subgroups (no bone graft: 6, onlay allograft: 7, and overlapping allograft: 5) according to our treatment strategy.
Results:
The median interval from the initial surgery to the revision was 94.5 months (range, 21–219 months), and the median follow-up period from the revision surgery was 88.0 months (range, 24–179 months). At the last follow-up, 9 of the 18 patients maintained their endoprostheses, and the 5-year prosthesis survival rate was 57.9%. Limb survival was 100%. Five-year prosthesis survival rate was 66.7% in the no bone graft group, 85.7% in the onlay allograft group while 30.0% in the overlapping allograft group. In the no bone graft group and onlay allograft group, 66.7% (4/6) and 57.1% (4/7) maintained their revision prostheses while no prostheses survived in the overlapping allograft group. Recurrent stem loosening was observed in 14.2% (1/7) and 60.0% (3/5) of the onlay allograft and overlapping allograft groups, respectively, despite allograft bone union. The complication rate was 66.7% (12/18) in the entire cohort. The most common type of complication was infection (n = 6), followed by aseptic loosening (n = 4) and mechanical failure (n = 2).
Conclusions
This study indicates that onlay allograft can be used as a supportive method in revising failed endoprosthesis if the extent of host bone destruction is extensive. However, applying overlapping allograft to secure bone stock showed a high rate of mechanical failures and infection in the long term. Future studies with a larger cohort are necessary to assess the prognostic factors for the higher complication rate in overlapping allograft and the need for overlapping allograft. Surveillance with consideration of the risk of anteromedial osteolysis in allograft and efforts for prevention of periprosthetic infection are essential.
6.Long-term Outcomes of Vitrectomy with Internal Limiting Membrane Removal to Treat Macular Hole Retinal Detachment
Young Joon JEON ; Jong Woo KIM ; Chul Gu KIM ; Su Jin YOO ; Hyeong Seok KIM ; Joo Yeon KIM ; Jae Hui KIM
Journal of the Korean Ophthalmological Society 2022;63(10):849-858
Purpose:
To evaluate the long-term clinical outcomes of vitrectomy with internal limiting membrane (ILM) removal for patients with macular hole retinal detachment (MHRD).
Methods:
We retrospectively reviewed the medical records of patients with MHRD who underwent vitrectomy with ILM removal. The incidence of retinal re-attachment and MH closure at 1 month were calculated. Factors associated with RD recurrence were investigated. Visual acuity before surgery was compared to that at the final visit.
Results:
Forty-two eyes were included; the mean follow-up period was 38.5 ± 19.1 months. Twenty-three eyes received gas injections and 19 silicone oil injections. Retinal re-attachment occurred in 41 (97.6%). Type 1 closure was noted in 21 eyes (51.2%) and type 2 in 20 (48.8%). Recurrent RD was noted in five eyes (14.6%) within 3 months of initial surgery. Type 2 closure was a risk factor for recurrence (p = 0.021). The logarithm of the minimum angle of resolution best-corrected visual acuity improved significantly from 1.79 ± 0.79 before surgery to 1.30 ± 0.75 after surgery (p < 0.001).
Conclusions
Retinal re-attachment was noted in most patients and the MH closed in approximately half of all patients after vitrectomy with ILM removal to treat MHRD. RD did not recur later than 3 months after initial surgery. Further efforts to increase the rate of type 1 closure are required.
7.Osteoarthritis of the Knee after Curettage and Polymethylmethacrylate Filling for Giant Cell Tumor of Bone at the Distal Femur
Wan-Hyeong CHO ; Chang-Bae KONG ; Dae-Geun JEON ; Young Min KWON ; Won Seok SONG
The Journal of the Korean Orthopaedic Association 2022;57(5):385-391
Purpose:
This study examined the prevalence of osteoarthritis of the knee after curettage and polymethylmethacrylate (PMMA) application for giant cell tumor of the bone (GCTB) and factors affecting the development of osteoarthritis of the knee.
Materials and Methods:
Fifty-five patients with GCTB of the distal femur who were treated with curettage and PMMA filling between June 2001 and June 2016 were reviewed retrospectively. The development of osteoarthritis of the knee, as Kellgren–Lawrence grade 3 or 4, was determined by radiography of the latest follow-up data. This study evaluated the influence of the factors on the development of osteoarthritic changes. Only patients followed up for more than five years were included and the median follow-up was 77 months (range, 60–237 months).
Results:
Osteoarthritis of the knee was observed in 10 patients (18%) of whom three showed preoperative arthritic changes and did not progress. Seven (13%) patients experienced progression of the arthritic changes after surgery at a median of five years (range, 4–12 years). On the other hand, none of them received total knee arthroplasty. Among seven patients who showed progression of arthritis, four patients presented with a pathologic fracture initially and showed arthritic changes at a median of 4.5 years after surgery. The other three patients showed arthritic changes after ten years or more. Pathologic fractures (p=0.0001) and subchondral bone involvement (p=0.011) were significant risk factors for the development of osteoarthritis.
Conclusion
The incidence of development of osteoarthritis of the knee after curettage and PMMA application at distal femoral GCTB was 13%, but none of these patients received further surgery, such as total knee arthroplasty. The pathologic fracture and subchondral bone involvement are risk factors for arthritic changes in the midterm follow-up.
8.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
9.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
10.Periprosthetic Fracture around Tumor Prosthesis, Comparison of Results with or without Cortical Strut Onlay Allograft
Yongsung KIM ; Wan Hyeong CHO ; Won Seok SONG ; Kyupyung LEE ; Dae-Geun JEON
The Journal of the Korean Orthopaedic Association 2021;56(1):42-50
Purpose:
Periprosthetic fractures of a tumor prosthesis are rare but have difficulties in achieving sound fixation because of the poor bone quality, which increases the risk of loosening or re-fracture, even after bone union. A cortical strut onlay allograft was adopted for peri-prosthetic fractures after hip arthroplasty into the periprosthetic fracture of a tumor prosthesis, assuming that it would assist in firm fixation, shorten the time to union, and increase the bone stock, thereby, lower the chance of loosening and re-fracture.
Materials and Methods:
This study reviewed 27 patients (30 cases) of periprosthetic fracture of tumor prosthesis. Sixteen cases (allograft group) had augmentation with an onlay allograft, while 14 cases (conventional group) had internal fixation or conservative treatment.The following were assessed; mode of periprosthetic fracture, difference in the time to union between a strut cortical onlay allograft and without it, and survival of prosthesis, complication, and functional outcome between the two groups.
Results:
According to the unified classification system (UCS), 21 cases were type B (70.0%; B1, 14; B2, 1; B3, 6) and 9 cases were type C.The five-, 10-year survival of the 30 reconstructions by Kaplan–Meier plot was 84.5%±4.18% and 42.2%±7.83%, respectively. The average time to bone union of the entire cohort was 5.1 months (range, 2.0–11.2 months). The allograft group (3.5 months) showed a shorter period for union than the conventional group (7.2 months) (p<0.0001). All four cases of major complications occurred in the conventional group. Two cases with loosening and anterior angulation were treated with a change of prosthesis, and another with infection underwent amputation. The remaining case with loosening had conservative management. At the final follow-up, the average Musculosketal Tumor Society score of the allograft group (26.1) was better than that of the conventional group (20.9).
Conclusion
Bone union in periprosthetic fractures of a tumor prosthesis can be achieved, but the minimization of complications is important. An onlay allograft facilitates firm fixation and increases the bone stock with a shortened time to union. This simple method can minimize the risk of loosening, joint contracture, and re-fracture.

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