Time Clinical Trial
Official title:
Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy
Verified date | April 2024 |
Source | Shanghai Zhongshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use
Status | Completed |
Enrollment | 303 |
Est. completion date | October 15, 2019 |
Est. primary completion date | October 15, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - (I) thoracic ESCC - (II) no history of concomitant or prior malignancy - (III) Completed one cycle of nCRT - (IV) Received endoscopic radical surgery for esophageal cancer Exclusion Criteria: - (I)other histological subtypes - (II)Received ESD treatment - (III) Radiation dose greater than 50Gy - (IV) Metastatic esophageal squamous cell carcinoma |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: — View Citation
Chidambaram S, Owen R, Sgromo B, Chmura M, Kisiel A, Evans R, Griffiths EA, Castoro C, Gronnier C, MaoAwyes MA, Gutschow CA, Piessen G, Degisors S, Alvieri R, Feldman H, Capovilla G, Grimminger PP, Han S, Low DE, Moore J, Gossage J, Voeten D, Gisbertz SS, — View Citation
Chiu CH, Chao YK, Chang HK, Tseng CK, Chan SC, Liu YH, Chen WH. Interval between neoadjuvant chemoradiotherapy and surgery for esophageal squamous cell carcinoma: does delayed surgery impact outcome? Ann Surg Oncol. 2013 Dec;20(13):4245-51. doi: 10.1245/s — View Citation
Delanian S, Lefaix JL. Current management for late normal tissue injury: radiation-induced fibrosis and necrosis. Semin Radiat Oncol. 2007 Apr;17(2):99-107. doi: 10.1016/j.semradonc.2006.11.006. — View Citation
Eyck BM, van der Wilk BJ, Noordman BJ, Wijnhoven BPL, Lagarde SM, Hartgrink HH, Coene PPLO, Dekker JWT, Doukas M, van der Gaast A, Heisterkamp J, Kouwenhoven EA, Nieuwenhuijzen GAP, Pierie JEN, Rosman C, van Sandick JW, van der Sangen MJC, Sosef MN, van d — View Citation
Eyck BM, van Lanschot JJB, Hulshof MCCM, van der Wilk BJ, Shapiro J, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch OR, Creemers GM, Punt CJA, Plukker JT — View Citation
Gakuhara A, Yamashita K, Miyazaki Y, Adachi K, Momose K, Saito T, Tanaka K, Makino T, Yamamoto K, Takahashi T, Kurokawa Y, Nakajima K, Eguchi H, Doki Y. Association between fibrosis around the tumor and postoperative infectious complication in patients wi — View Citation
Kim JY, Correa AM, Vaporciyan AA, Roth JA, Mehran RJ, Walsh GL, Rice DC, Ajani JA, Maru DM, Bhutani MS, Welsh J, Marom EM, Swisher SG, Hofstetter WL. Does the timing of esophagectomy after chemoradiation affect outcome? Ann Thorac Surg. 2012 Jan;93(1):207 — View Citation
Klevebro F, Nilsson K, Lindblad M, Ekman S, Johansson J, Lundell L, Ndegwa N, Hedberg J, Nilsson M. Association between time interval from neoadjuvant chemoradiotherapy to surgery and complete histological tumor response in esophageal and gastroesophageal — View Citation
Nilsson K, Klevebro F, Rouvelas I, Lindblad M, Szabo E, Halldestam I, Smedh U, Wallner B, Johansson J, Johnsen G, Aahlin EK, Johannessen HO, Hjortland GO, Bartella I, Schroder W, Bruns C, Nilsson M. Surgical Morbidity and Mortality From the Multicenter Ra — View Citation
Ohashi S, Miyamoto S, Kikuchi O, Goto T, Amanuma Y, Muto M. Recent Advances From Basic and Clinical Studies of Esophageal Squamous Cell Carcinoma. Gastroenterology. 2015 Dec;149(7):1700-15. doi: 10.1053/j.gastro.2015.08.054. Epub 2015 Sep 12. — View Citation
Petrelli F, Sgroi G, Sarti E, Barni S. Increasing the Interval Between Neoadjuvant Chemoradiotherapy and Surgery in Rectal Cancer: A Meta-analysis of Published Studies. Ann Surg. 2016 Mar;263(3):458-64. doi: 10.1097/SLA.0000000000000368. — View Citation
Piessen G, Messager M, Mirabel X, Briez N, Robb WB, Adenis A, Mariette C. Is there a role for surgery for patients with a complete clinical response after chemoradiation for esophageal cancer? An intention-to-treat case-control study. Ann Surg. 2013 Nov;2 — View Citation
Rombouts AJM, Hugen N, Elferink MAG, Nagtegaal ID, de Wilt JHW. Treatment Interval between Neoadjuvant Chemoradiotherapy and Surgery in Rectal Cancer Patients: A Population-Based Study. Ann Surg Oncol. 2016 Oct;23(11):3593-3601. doi: 10.1245/s10434-016-52 — View Citation
Shapiro J, van Hagen P, Lingsma HF, Wijnhoven BP, Biermann K, ten Kate FJ, Steyerberg EW, van der Gaast A, van Lanschot JJ; CROSS Study Group. Prolonged time to surgery after neoadjuvant chemoradiotherapy increases histopathological response without affec — View Citation
Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. — View Citation
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caa — View Citation
van der Wilk BJ, Noordman BJ, Neijenhuis LKA, Nieboer D, Nieuwenhuijzen GAP, Sosef MN, van Berge Henegouwen MI, Lagarde SM, Spaander MCW, Valkema R, Biermann K, Wijnhoven BPL, van der Gaast A, van Lanschot JJB, Doukas M, Nikkessen S, Luyer M, Schoon EJ, R — View Citation
van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar — View Citation
Verweij ME, Franzen J, van Grevenstein WMU, Verkooijen HM, Intven MPW. Timing of rectal cancer surgery after short-course radiotherapy: national database study. Br J Surg. 2023 Jun 12;110(7):839-845. doi: 10.1093/bjs/znad113. — View Citation
Wang J, Zhang K, Liu T, Song Y, Hua P, Chen S, Li J, Liu Y, Zhao Y. Efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in locally advanced esophageal cancer: A meta-analysis. Front Oncol. 2022 Sep 5;12:974684. doi: 10.3389/fonc.20 — View Citation
Yan X, Duan H, Ni Y, Zhou Y, Wang X, Qi H, Gong L, Liu H, Tian F, Lu Q, Sun J, Yang E, Zhong D, Wang T, Huang L, Wang J, Chaoyang Wang, Wang Y, Wan Z, Lei J, Zhao J, Jiang T. Tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically re — View Citation
Yang Y, Liu J, Liu Z, Zhu L, Chen H, Yu B, Zhang R, Shao J, Zhang M, Li C, Li Z. Two-year outcomes of clinical N2-3 esophageal squamous cell carcinoma after neoadjuvant chemotherapy and immunotherapy from the phase 2 NICE study. J Thorac Cardiovasc Surg. — View Citation
Yun JK, Chong BK, Kim HJ, Lee IS, Gong CS, Kim BS, Lee GD, Choi S, Kim HR, Kim DK, Park SI, Kim YH. Comparative outcomes of robot-assisted minimally invasive versus open esophagectomy in patients with esophageal squamous cell carcinoma: a propensity score — View Citation
* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The overall survival of the overall population | Does the overall population survive | 5 years | |
Primary | The Disease-Free survival of the overall population | Is there any tumor metastasis or recurrence in the overall population | 5 years | |
Primary | The overall survival of the non-PCR population | Does the non-PCR population survive | 5 years | |
Primary | The Disease-Free survival of the non-PCR population | Is there any tumor metastasis or recurrence in the non-PCR population | 5 years | |
Primary | The overall survival of the PCR population | Does the PCR population survive | 5 years | |
Primary | The Disease-Free survival of the PCR population | Is there any tumor metastasis or recurrence in the PCR population | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04656912 -
Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
|
||
Recruiting |
NCT01499589 -
Can the Usage of Regional Block Room Save the Time of Anesthesia Team
|
N/A | |
Recruiting |
NCT03738371 -
Formation of Health Professionals Through in Situ Simulation to Improve Performances During the Initial Step of Thrombectomy for Ischemic Strokes
|
||
Not yet recruiting |
NCT05256459 -
Clinical Intervention Strategy for High-risk Group of Hepatitis B Related Hepatocellular Carcinoma
|
||
Completed |
NCT05749991 -
Efficacy and Retention of Sealants Placement Using Two Isolation Systems
|
N/A | |
Recruiting |
NCT05256888 -
Time-Restricted Eating to Address Persistent Cancer-Related Fatigue
|
N/A | |
Completed |
NCT02995369 -
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
|
N/A | |
Completed |
NCT04714112 -
Low-dose Intravenous Dexamethasone at Different Times as Adjunvants for Brachial Plexus Blocks
|
Phase 4 | |
Recruiting |
NCT06012890 -
Performance of Acquisition Automation of Cardiac MRI
|