Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma

NCT06364566 | Completed

• 1 other identifier: time-exploring
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Time

Outcome Measures

Primary Outcomes (6)

• The overall survival of the overall population

  Does the overall population survive

  5 years

• The Disease-Free survival of the overall population

  Is there any tumor metastasis or recurrence in the overall population

  5 years

• The overall survival of the non-PCR population

  Does the non-PCR population survive

  5 years

• The Disease-Free survival of the non-PCR population

  Is there any tumor metastasis or recurrence in the non-PCR population

  5 years

• The overall survival of the PCR population

  Does the PCR population survive

  5 years

• The Disease-Free survival of the PCR population

  Is there any tumor metastasis or recurrence in the PCR population

  5 years

Study Arms (2)

Short interval group

EXPERIMENTAL

The patient underwent minimally invasive esophagectomy within 50 days after receiving neoadjuvant therapy

Radiation: Neoadjuvant chemradiotherapy; Procedure: Minimally invasive esophagectomy

Long interval group

EXPERIMENTAL

The patient underwent minimally invasive esophagectomy 50 days after receiving neoadjuvant therapy

Radiation: Neoadjuvant chemradiotherapy; Procedure: Minimally invasive esophagectomy

Interventions

Neoadjuvant chemradiotherapy RADIATION

Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage

Long interval group; Short interval group

Minimally invasive esophagectomy PROCEDURE

The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes

Long interval group; Short interval group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (I)other histological subtypes
• (II)Received ESD treatment
• (III) Radiation dose greater than 50Gy
• (IV) Metastatic esophageal squamous cell carcinoma

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (24)

• 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/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 RESULT

• 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.

  PMID: 26376349 RESULT

• 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 Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

  PMID: 22646630 RESULT

• 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 JTM, Verheul HMW, Spillenaar Bilgen EJ, van der Sangen MJC, Rozema T, Ten Kate FJW, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS Study Group. Ten-Year Outcome of Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal Cancer: The Randomized Controlled CROSS Trial. J Clin Oncol. 2021 Jun 20;39(18):1995-2004. doi: 10.1200/JCO.20.03614. Epub 2021 Apr 23.

  PMID: 33891478 RESULT

• 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. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.

  PMID: 21684205 RESULT

• 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;258(5):793-9; discussion 799-800. doi: 10.1097/SLA.0000000000000228.

  PMID: 24096755 RESULT

• 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 der Zaag ES, Spaander MCW, Valkema R, Lingsma HF, Steyerberg EW, van Lanschot JJB; SANO-study group. Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer. Trials. 2021 May 17;22(1):345. doi: 10.1186/s13063-021-05274-w.

  PMID: 34001287 RESULT

• 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.

  PMID: 24263329 RESULT

• 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/s10434-016-5294-0. Epub 2016 Jun 1.

  PMID: 27251135 RESULT

• 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.

  PMID: 37172197 RESULT

• 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.

  PMID: 17395040 RESULT

• 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/s10434-013-3139-7.

  PMID: 23959050 RESULT

• 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 affecting survival in patients with esophageal or junctional cancer. Ann Surg. 2014 Nov;260(5):807-13; discussion 813-4. doi: 10.1097/SLA.0000000000000966.

  PMID: 25379852 RESULT

• 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 Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer. Ann Surg. 2020 Nov;272(5):684-689. doi: 10.1097/SLA.0000000000004340.

  PMID: 32833767 RESULT

• 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, Roef MJ, van Lijnschoten I, Oostenbrug LE, Riedl RG, Gisbertz SS, Krishnadath KK, Bennink RJ, Meijer SL; Collaborators:. Active Surveillance Versus Immediate Surgery in Clinically Complete Responders After Neoadjuvant Chemoradiotherapy for Esophageal Cancer: A Multicenter Propensity Matched Study. Ann Surg. 2021 Dec 1;274(6):1009-1016. doi: 10.1097/SLA.0000000000003636.

  PMID: 31592898 RESULT

• 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, Ruurda J, van Hillegersberg R, D'Journo XB, Chmelo J, Phillips AW, Rosati R, Hanna GB, Maynard N, Hofstetter W, Ferri L, Berge Henegouwen MI, Markar SR. Delayed Surgical Intervention After Chemoradiotherapy in Esophageal Cancer: (DICE) Study. Ann Surg. 2023 Nov 1;278(5):701-708. doi: 10.1097/SLA.0000000000006028. Epub 2023 Jul 21.

  PMID: 37477039 RESULT

• 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: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.

  PMID: 22552194 RESULT

• 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-weighted analysis. Dis Esophagus. 2020 May 15;33(5):doz071. doi: 10.1093/dote/doz071.

  PMID: 31665266 RESULT

• 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 junction cancer: a national cohort study. Dis Esophagus. 2020 May 15;33(5):doz078. doi: 10.1093/dote/doz078.

  PMID: 31676895 RESULT

• 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 with esophageal cancer who underwent preoperative therapy. World J Surg. 2024 Apr;48(4):914-923. doi: 10.1002/wjs.12100. Epub 2024 Feb 6.

  PMID: 38319155 RESULT

• 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):207-12; discussion 212-3. doi: 10.1016/j.athoracsur.2011.05.021. Epub 2011 Oct 1.

  PMID: 21962263 RESULT

• 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.2022.974684. eCollection 2022.

  PMID: 36158679 RESULT

• 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. 2024 Mar;167(3):838-847.e1. doi: 10.1016/j.jtcvs.2023.08.056. Epub 2023 Sep 9.

  PMID: 37696429 RESULT

• 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 resectable esophageal cancer: A prospective, single-arm, phase II study (TD-NICE). Int J Surg. 2022 Jul;103:106680. doi: 10.1016/j.ijsu.2022.106680. Epub 2022 May 18.

  PMID: 35595021 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 15, 2024
• Study Start: October 15, 2010
• Primary Completion: October 15, 2016
• Study Completion: October 15, 2019
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)