Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606916
• Other study ID #: GYX2015-012
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: August 2020

Study information

• Verified date: September 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pathologically or cytologically confirmed esophageal squamous cell carcinoma.

• Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies.

• Aging from 70 to 80.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Charlson's weighted index of comorbidities (WIC) =4;

• White blood cell count =4×109 /L, neutrophile granulocyte count=1.5×109 /L, platelet count=100×109 /L, hemoglobin =100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.

• Weight loss =15% within the past half year.

• Forced expiratory volume in 1 s= 1 L.

• Patients and their family signed the informed consents.

Exclusion Criteria:

• Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.

• Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation.

• Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.)

• Malignant pleural effusion or pericardial effusion.

• Weight loss >10% within the past 3 months.

• Recruited in other clinical trials within 30 days

• Drug addiction, long-term alcohol abuse and AIDS patients.

• Uncontrollable epileptic attack or psychotic patients without self-control ability.

• Severe allergy or idiosyncrasy.

• Not suitable for this study judged by researchers.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Radiation:
• SMART
Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )

Drug:
• DDP
DDP(25 mg/m2.qw) for six weeks.
• S-1
S-1(40 mg/m2.Bid .po) on D1-14,D22-35 during radiotherapy

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (26)

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Harada K, Kawaguchi S, Supriatno, Kawashima Y, Yoshida H, Sato M. S-1, an oral fluoropyrimidine anti-cancer agent, enhanced radiosensitivity in a human oral cancer cell line in vivo and in vitro: involvement possibility of inhibition of survival signal, Akt/PKB. Cancer Lett. 2005 Aug 26;226(2):161-168. — View Citation

Iwase H, Shimada M, Tsuzuki T, Hirashima N, Okeya M, Hibino Y, Ryuge N, Yokoi M, Kida Y, Kuno T, Tanaka Y, Kato B, Esaki M, Urata N, Kato E. Concurrent chemoradiotherapy with a novel fluoropyrimidine, S-1, and cisplatin for locally advanced esophageal cancer: long-term results of a phase II trial. Oncology. 2013;84(6):342-9. doi: 10.1159/000348383. Epub 2013 May 14. — View Citation

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Nakata B, Mitachi Y, Tsuji A, Yamamitsu S, Hirata K, Shirasaka T, Hirakawa K. Combination phase I trial of a novel oral fluorouracil derivative S-1 with low-dose cisplatin for unresectable and recurrent gastric cancer (JFMC27-9902). Clin Cancer Res. 2004 Mar 1;10(5):1664-9. — View Citation

Nakata E, Fukushima M, Takai Y, Nemoto K, Ogawa Y, Nomiya T, Nakamura Y, Milas L, Yamada S. S-1, an oral fluoropyrimidine, enhances radiation response of DLD-1/FU human colon cancer xenografts resistant to 5-FU. Oncol Rep. 2006 Sep;16(3):465-71. — View Citation

Nemoto K, Matsushita H, Ogawa Y, Takeda K, Takahashi C, Britton KR, Takai Y, Miyazaki S, Miyata T, Yamada S. Radiation therapy combined with cis-diammine-glycolatoplatinum (Nedaplatin) and 5-fluorouracil for untreated and recurrent esophageal cancer. Am J Clin Oncol. 2003 Feb;26(1):46-9. — View Citation

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Settle SH, Bucci MK, Palmer MB, et al. PET/CT fusion with treatment planning CT (TP CT) shows predominant pattern of locoregional failure in esophageal patients treated with chemoradiation (CRT) is in GTV. Int J Radiat Oncol Biol Phys 2008;72:S72-S73.

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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. — View Citation

Welsh J, Palmer MB, Ajani JA, Liao Z, Swisher SG, Hofstetter WL, Allen PK, Settle SH, Gomez D, Likhacheva A, Cox JD, Komaki R. Esophageal cancer dose escalation using a simultaneous integrated boost technique. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):468-74. doi: 10.1016/j.ijrobp.2010.10.023. Epub 2010 Dec 1. — View Citation

Yokota T, Onozawa Y, Boku N, Hamauchi S, Tsushima T, Taniguchi H, Todaka A, Machida N, Yamazaki K, Fukutomi A, Yasui H. S-1 monotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck after progression on platinum-based chemotherapy. Jpn J Clin Oncol. 2011 Dec;41(12):1351-7. doi: 10.1093/jjco/hyr147. Epub 2011 Oct 5. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate	the percentage of patients who had partial remission or complete remission after chemoradiotherapy	2-year
Secondary	progression-free survival		3-year
Secondary	overall survival		3-year
Secondary	grade 3 or 4 toxicities according to CTCAE4.0	the percentage of patients who develop grade 3 or 4 toxicities during and 1 year after radiochemotherapy	1 year after radiochemotherapy