NCT04115618

Brief Summary

This study was designed to predict the toxicity and efficacy of Simultaneous Integrated Boost Intensity-modulated Chemoradiotherapy in Upper Thoracic I-IVA 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
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Longer than P75 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

Study Start

First participant enrolled

January 1, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3.9 years

First QC Date

September 29, 2019

Last Update Submit

October 2, 2019

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal cancerChemoradiotherapySimultaneous Integrated Boost Intensity

Outcome Measures

Primary Outcomes (1)

  • Toxicity Effect

    Toxicity effect defined as over CTCAE 4 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.

    8 Weeks

Secondary Outcomes (2)

  • PFS

    One month

  • OS

    One month

Study Arms (1)

SIB

EXPERIMENTAL

Simultaneous integrated boost intensity-modulated chemoradiotherapy

Radiation: Simultaneous integrated boost intensity-modulated chemoradiotherapy

Interventions

Simultaneous integrated boost intensity-modulated chemoradiotherapyRADIATION

Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.

SIB

Eligibility Criteria

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

You may qualify if:

  • Histological or cytologic diagnosis of esophageal squamous carcinoma;
  • Aged 18-75 years;
  • KPS ≥ 70;
  • Upper thoracic esophageal squamous carcinoma: the upper margin of the lesion is located between the entrance of esophagus and the inferior edge of the azygos vein;
  • Stage I-IVA(AJCC 6th,2009);
  • Not able to be surgically resection or rejected;
  • Not have received any prior anticancer therapy;
  • No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥4x109/L, Neutrophils (ANC )≥1.5x10\^9/L, platelet count ≥100x 10\^9/L, serum creatinine\<1.5 mg/dL,urea nitrogen \<8 mmol/L;
  • No history of malignancy;
  • No perforation of esophagus, no deep ulcer of esophagus;
  • Joined the study voluntarily and signed informed consent form.

You may not qualify if:

  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
  • Patient who has metastasis such as lung, liver metastasis;
  • Other malignant tumors;
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  • Uncontrollable heart disease, diabetes and hypertension, pulmonary fibrosis, and chest confirmed active pulmonary inflammation require antibiotic treatment, as well as superior vena cava compression syndrome;
  • After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy;
  • Combination of pure red cell anemia or gamma globulin;
  • Allergic to any medication component studied.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal Neoplasms

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

Central Study Contacts

Xi Yang, Phd

CONTACT

86-17321296901ntgeorge@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 4, 2019

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)