NCT02384811

Brief Summary

The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for 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
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

March 2, 2015

Last Update Submit

September 4, 2017

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinomapostoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Local control rate

    2 years

Secondary Outcomes (2)

  • Overall survival

    5 year

  • Safety: Frequencies of treatment-related adverse event categories by NCI-CTC

    3 months

Study Arms (1)

Radiation group

EXPERIMENTAL

Radiation therapy

Radiation: radiation

Interventions

radiationRADIATION

A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.

Radiation group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75；ECOG 0-2
  • Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
  • T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
  • No radiotherapy, chemotherapy or other treatments pre(post)surgery
  • PS ECOG 0-2
  • Life expectancy of more than 3 months
  • Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN • Renal function: creatinine \< 1.5 x ULN
  • No immuno-deficiency
  • Use of an effective contraceptive for adults to prevent pregnancy.

You may not qualify if:

  • Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
  • Participation in other interventional clinical trials within 30 days
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
  • Drug addiction, Alcoholism or AIDS
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • Unsuitable to be enrolled in the trial in the opinion of the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Zhang X, Ai D, Wang J, Chen Y, Liu Q, Deng J, Yang H, Nie Y, Chen W, Zhao W, Zhao K. The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial. Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 2021.

    PMID: 34295813DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiation

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)

Physical Phenomena

Study Officials

  • Jia-qing Xiang, M.M

    Fudan University

    PRINCIPAL INVESTIGATOR

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
director

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 10, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2019

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

CN(2)