NCT02325986

Brief Summary

The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.

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
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

December 16, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

December 16, 2014

Last Update Submit

November 19, 2015

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

radiotherapyesophageal carcinomachemotherapy

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine the tumor response. Tumor response was evaluated by CT 8 weeks after chemoradiotherapy.

    within 8 weeks after the treatment(plus or minus 5 days)

Secondary Outcomes (2)

  • safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).

    up to 3 years

  • overall survival

    up to 3 years

Study Arms (1)

Weekly PF with radiation

EXPERIMENTAL

4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).

Drug: fluorouracilDrug: CisplatinRadiation: Intensity-modulated radiation therapy

Interventions

fluorouracilDRUG

cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

Also known as: 5-FU
Weekly PF with radiation
CisplatinDRUG

cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

Weekly PF with radiation
Intensity-modulated radiation therapyRADIATION

cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)

Also known as: IMRT
Weekly PF with radiation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • R0 resection for primary esophageal squamous cell carcinoma with two-incision esophagectomy (Ivor Lewis approach)25 or three-incision (right thoracotomy, midline laparotomy and left cervical incisions) esophagectomy with cervical esophagogastric anastomosis.
  • Absence of previous thoracic radiotherapy.
  • Cervical and/or thoracic postoperative recurrence (biopsy proven or positron emission tomography/computed tomography (PET/CT) proven or follow-up computed tomography (CT) showed progression of disease).
  • Absence of distant metastasis at recurrence.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2

You may not qualify if:

  • Younger than 18 or older than 70 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above
  • Other cancer history.
  • Serious cardiac, liver, or pulmonary disease.
  • Previous radiotherapy history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SYSU Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (11)

  • Rice TW, Rusch VW, Apperson-Hansen C, Allen MS, Chen LQ, Hunter JG, Kesler KA, Law S, Lerut TE, Reed CE, Salo JA, Scott WJ, Swisher SG, Watson TJ, Blackstone EH. Worldwide esophageal cancer collaboration. Dis Esophagus. 2009;22(1):1-8. doi: 10.1111/j.1442-2050.2008.00901.x.

    PMID: 19196264BACKGROUND

  • Kato H, Miyazaki T, Nakajima M, Sohda M, Fukai Y, Masuda N, Fukuchi M, Manda R, Tsukada K, Kuwano H. Prediction of hematogenous recurrence in patients with esophageal carcinoma. Jpn J Thorac Cardiovasc Surg. 2003 Nov;51(11):599-608. doi: 10.1007/BF02736700.

    PMID: 14650590BACKGROUND

  • Nakamura T, Ota M, Narumiya K, Sato T, Ohki T, Yamamoto M, Mitsuhashi N. Multimodal treatment for lymph node recurrence of esophageal carcinoma after curative resection. Ann Surg Oncol. 2008 Sep;15(9):2451-7. doi: 10.1245/s10434-008-0016-x. Epub 2008 Jul 1.

    PMID: 18592318BACKGROUND

  • Shioyama Y, Nakamura K, Ohga S, Nomoto S, Sasaki T, Yamaguchi T, Toba T, Yoshitake T, Terashima H, Honda H. Radiation therapy for recurrent esophageal cancer after surgery: clinical results and prognostic factors. Jpn J Clin Oncol. 2007 Dec;37(12):918-23. doi: 10.1093/jjco/hym138.

    PMID: 18211982BACKGROUND

  • Kobayashi R, Yamashita H, Okuma K, Shiraishi K, Ohtomo K, Nakagawa K. Salvage radiation therapy and chemoradiation therapy for postoperative locoregional recurrence of esophageal cancer. Dis Esophagus. 2014 Jan;27(1):72-8. doi: 10.1111/dote.12068. Epub 2013 Apr 2.

    PMID: 23551708BACKGROUND

  • Yuan G, Wu L, Huang M, Li N, An J. A phase II study of concurrent chemo-radiotherapy with weekly nedaplatin in advanced squamous cell carcinoma of the uterine cervix. Radiat Oncol. 2014 Feb 18;9:55. doi: 10.1186/1748-717X-9-55.

    PMID: 24533532RESULT

  • Nakagawa S, Kanda T, Kosugi S, Ohashi M, Suzuki T, Hatakeyama K. Recurrence pattern of squamous cell carcinoma of the thoracic esophagus after extended radical esophagectomy with three-field lymphadenectomy. J Am Coll Surg. 2004 Feb;198(2):205-11. doi: 10.1016/j.jamcollsurg.2003.10.005.

    PMID: 14759776RESULT

  • Stahl M, Stuschke M, Lehmann N, Meyer HJ, Walz MK, Seeber S, Klump B, Budach W, Teichmann R, Schmitt M, Schmitt G, Franke C, Wilke H. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus. J Clin Oncol. 2005 Apr 1;23(10):2310-7. doi: 10.1200/JCO.2005.00.034.

    PMID: 15800321RESULT

  • Bao Y, Liu S, Zhou Q, Cai P, Anfossi S, Li Q, Hu Y, Liu M, Fu J, Rong T, Li Q, Liu H. Three-dimensional conformal radiotherapy with concurrent chemotherapy for postoperative recurrence of esophageal squamous cell carcinoma: clinical efficacy and failure pattern. Radiat Oncol. 2013 Oct 18;8:241. doi: 10.1186/1748-717X-8-241.

    PMID: 24139225RESULT

  • Jingu K, Nemoto K, Matsushita H, Takahashi C, Ogawa Y, Sugawara T, Nakata E, Takai Y, Yamada S. Results of radiation therapy combined with nedaplatin (cis-diammine-glycoplatinum) and 5-fluorouracil for postoperative locoregional recurrent esophageal cancer. BMC Cancer. 2006 Mar 4;6:50. doi: 10.1186/1471-2407-6-50.

    PMID: 16515704RESULT

  • Ma DY, Tan BX, Liu M, Li XF, Zhou YQ, Lu Y. Concurrent three-dimensional conformal radiotherapy and chemotherapy for postoperative recurrence of mediastinal lymph node metastases in patients with esophageal squamous cell carcinoma: a phase 2 single-institution study. Radiat Oncol. 2014 Jan 19;9:28. doi: 10.1186/1748-717X-9-28.

    PMID: 24438695RESULT

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal Neoplasms

Interventions

FluorouracilCisplatinRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Yujia Zhu, MD

    Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, P.R. China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujia Zhu, MD

CONTACT

86-20-87343385zhuyuj@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physicion

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 25, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CN(1)