NCT01937208

Brief Summary

Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with localized carcinoma of the esophagus selected for nonsurgical treatment. The standard radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology. Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III, randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal 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
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2013

Typical duration 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

August 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

August 25, 2013

Last Update Submit

September 3, 2013

Conditions

Esophageal Carcinoma

Keywords

Esophageal Carcinomachemoradiationradiation dose

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Other Outcomes (2)

  • local control rate; relapse location; toxicity

    5 years

  • radiation-related advent events

    at least 3 years

Study Arms (2)

high-dose

EXPERIMENTAL

concurrent chemoradiation:CT:DDP 25mg/m2 D1+docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：60Gy/30F/6W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 75mg/m2 D1+docetaxel 75mg/m2 D1, Q3W

Radiation: intensity modulated radiation therapy in both armsDrug: concurrent chemotherapy with radiation

standard dose

ACTIVE COMPARATOR

concurrent chemoradiation:CT:DDP 25mg/m2 D1+Docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：50Gy/25F/5W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 5mg/m2 D1+Docetaxel75mg/m2 D1, Q3W

Radiation: intensity modulated radiation therapy in both armsDrug: concurrent chemotherapy with radiation

Interventions

intensity modulated radiation therapy in both armsRADIATION
high-dosestandard dose
concurrent chemotherapy with radiationDRUG

docetaxel plus cisplatin were used weekly in both arms

high-dosestandard dose

Eligibility Criteria

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

You may qualify if:

  • Histological or cytologic diagnosis of esophageal carcinoma
  • ECOG performance status 0-1
  • Age:18-70 years
  • Joined the study voluntarily and signed informed consent form
  • Patients must not have received any prior anticancer therapy
  • Unresectable disease, or refuse surgery.Stage Ⅰ-ⅣA（AJCC 2009）
  • Target lesions can be measured according to RECIST criteria
  • No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL\<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
  • Use of an effective contraceptive for adults to prevent pregnancy
  • Life expectancy of more than 3 months

You may not qualify if:

  • Multiple carcinomas of the esophagus,
  • Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
  • Metastatic disease (M1),
  • A primary tumor that extended to within 2 cm of the gastroesophageal junction,
  • Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
  • Concurrent pregnancy or lactation, history of a second malignancy other than nonmelanoma skin cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy, Intensity-ModulatedRadiation

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeuticsPhysical Phenomena

Study Officials

  • Xiao Zheng, MD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiao zheng, MD

CONTACT

0086-571-88122078zhengxiao@medmail.com

ming chen, PHD

CONTACT

0086-571-88122068chenming@sysucc.org.cn

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

August 25, 2013

First Posted

September 9, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

July 1, 2017

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations

CN(1)