NCT02607540

Brief Summary

A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway. The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

3.2 years

First QC Date

November 16, 2015

Last Update Submit

January 10, 2016

Conditions

Stage III Esophageal Squamous Cell CarcinomaStage II Esophageal Squamous Cell Carcinoma

Keywords

ChemoradiotherapyEsophageal Squamous CancerCisplatin-5-fluorouracil

Outcome Measures

Primary Outcomes (1)

  • overall survival, OS

    2 years

Secondary Outcomes (6)

  • progression-free survival,PFS

    2 years

  • overall remission rate, ORR

    16 weeks

  • serious adverse event,SAE

    16 weeks

  • quality of life, Qol

    16 weeks

  • pathologic complete response rate

    16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Two cycles PF-radiotherapy

EXPERIMENTAL

2 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32. radiotherapy： 50Gy，2 Gy/d，5d/w.

Other: 2 cycles cisplatin-5-fluorouracilRadiation: Radiotherapy

Four cycles PF-radiotherapy

ACTIVE COMPARATOR

4 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29, 57, 85；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88. radiotherapy： 50Gy，2 Gy/d，5d/w.

Other: 4 cycles cisplatin-5-fluorouracilRadiation: Radiotherapy

Interventions

2 cycles cisplatin-5-fluorouracilOTHER

2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.

Also known as: PF 2 cycles
Two cycles PF-radiotherapy
4 cycles cisplatin-5-fluorouracilOTHER

4 cycles cisplatin-5-fluoroura(PF 4 cycles): cilcisplatin: 75mg/m2 d1，29, 57, 85; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.

Also known as: PF 4 cycles
Four cycles PF-radiotherapy
RadiotherapyRADIATION

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Also known as: Radiation Therapy
Four cycles PF-radiotherapyTwo cycles PF-radiotherapy

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 45-75years old
  • Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
  • The patients have not received the surgery or chemo-radiotherapy.
  • Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
  • ALT、AST≤2.5\*N,Cr≤1.5\*N.
  • performance status score 0-2

You may not qualify if:

  • pregnant, lactating women
  • Oxaliplatin or fluorouracil Allergy or metabolic disorders
  • Radiotherapy contraindications
  • History of organ transplantation
  • Brain metastasis
  • The peripheral nervous system disorders
  • Severe infection
  • Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
  • Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
  • Other malignant tumor in recent 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Related Publications (8)

  • Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1.

    PMID: 20888705BACKGROUND

  • Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167.

    PMID: 11870157BACKGROUND

  • Ohtsu A, Boku N, Muro K, Chin K, Muto M, Yoshida S, Satake M, Ishikura S, Ogino T, Miyata Y, Seki S, Kaneko K, Nakamura A. Definitive chemoradiotherapy for T4 and/or M1 lymph node squamous cell carcinoma of the esophagus. J Clin Oncol. 1999 Sep;17(9):2915-21. doi: 10.1200/JCO.1999.17.9.2915.

    PMID: 10561371BACKGROUND

  • Ishida K, Ando N, Yamamoto S, Ide H, Shinoda M. Phase II study of cisplatin and 5-fluorouracil with concurrent radiotherapy in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG)/Japan Clinical Oncology Group trial (JCOG9516). Jpn J Clin Oncol. 2004 Oct;34(10):615-9. doi: 10.1093/jjco/hyh107.

    PMID: 15591460BACKGROUND

  • Hironaka S, Ohtsu A, Boku N, Muto M, Nagashima F, Saito H, Yoshida S, Nishimura M, Haruno M, Ishikura S, Ogino T, Yamamoto S, Ochiai A. Nonrandomized comparison between definitive chemoradiotherapy and radical surgery in patients with T(2-3)N(any) M(0) squamous cell carcinoma of the esophagus. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):425-33. doi: 10.1016/s0360-3016(03)00585-6.

    PMID: 12957254BACKGROUND

  • Bedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118.

    PMID: 17401004BACKGROUND

  • Shapiro J, ten Kate FJ, van Hagen P, Biermann K, Wijnhoven BP, van Lanschot JJ. Residual esophageal cancer after neoadjuvant chemoradiotherapy frequently involves the mucosa and submucosa. Ann Surg. 2013 Nov;258(5):678-88; discussion 688-9. doi: 10.1097/SLA.0b013e3182a6191d.

    PMID: 24096766BACKGROUND

  • Kato K, Nakajima TE, Ito Y, Katada C, Ishiyama H, Tokunaga SY, Tanaka M, Hironaka S, Hashimoto T, Ura T, Kodaira T, Yoshimura K. Phase II study of concurrent chemoradiotherapy at the dose of 50.4 Gy with elective nodal irradiation for Stage II-III esophageal carcinoma. Jpn J Clin Oncol. 2013 Jun;43(6):608-15. doi: 10.1093/jjco/hyt048. Epub 2013 Apr 12.

    PMID: 23585687BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shegan Gao, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    STUDY CHAIR

  • Tanyou Shan, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    STUDY DIRECTOR

  • Xiaoshan Feng, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    STUDY DIRECTOR

  • Jiachun Sun, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Xinshuai Wang, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Guoqiang Kong, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Xiaozhi Yuan, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Ruinuo Jia, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Dan Zhou, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Jing Ren, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Ruina Yang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Wei Wang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Yongxuan Liu, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Dan Wang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Shiyuan Song, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Weijiao Yin, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Yali Zhang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shegan Gao, Doctor

CONTACT

18638859977gsg112258@163.com

Tanyou Shan, Master

CONTACT

18537976669shantanyou@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2020

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

CN(1)