NCT03328234

Brief Summary

The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.

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
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2017

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

September 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

4 years

First QC Date

October 28, 2017

Last Update Submit

December 29, 2018

Conditions

IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Outcome Measures

Primary Outcomes (3)

  • Overall survival (OS)

    1 year

  • Overall survival (OS)

    2 year

  • Overall survival (OS)

    3 year

Secondary Outcomes (8)

  • Progression-free survival (PFS)

    1 year

  • Progression-free survival (PFS)

    2 year

  • Progression-free survival (PFS)

    3 year

  • Local recurrence-free rate（LRFS）

    1 year

  • Local recurrence-free rate（LRFS）

    2 year

  • +3 more secondary outcomes

Study Arms (2)

SIB-IMRT combined chemotherapy with IFI

EXPERIMENTAL
Radiation: SIB-IMRTDrug: PaclitaxelDrug: Platinum-Based DrugOther: Involved Field Irradiation (IFI)

SIB-IMRT with IFI

EXPERIMENTAL
Radiation: SIB-IMRTDrug: PaclitaxelDrug: Platinum-Based DrugOther: Involved Field Irradiation (IFI)

Interventions

SIB-IMRTRADIATION

Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.

SIB-IMRT combined chemotherapy with IFISIB-IMRT with IFI
PaclitaxelDRUG

45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks

SIB-IMRT combined chemotherapy with IFI
Platinum-Based DrugDRUG

Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks

SIB-IMRT combined chemotherapy with IFI
Involved Field Irradiation (IFI)OTHER

CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.

SIB-IMRT combined chemotherapy with IFISIB-IMRT with IFI

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\<70
  • Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
  • A untreated squamous esophageal carcinoma
  • Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
  • Adequate organ function
  • No known history of drug allergy
  • Blood routine examination : WBC≥4.0
  • hepatic and renal function are normal

You may not qualify if:

  • Age≥ 70 or ≤ 16
  • Already received the treatment of chemotherapy or radiotherapy
  • Pregnant or lactating females
  • Known drug allergy
  • Without agreement of informed consent form
  • Insufficient hepatorenal function or Blood routine examination
  • Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, 100021, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Xin Wang, MD

CONTACT

+86-13311583220beryl_wx2000@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal investigator

Study Record Dates

First Submitted

October 28, 2017

First Posted

November 1, 2017

Study Start

September 1, 2017

Primary Completion

August 31, 2021

Study Completion

December 31, 2022

Last Updated

January 2, 2019

Record last verified: 2018-12

Locations

CN(1)