NCT03790553

Brief Summary

The purpose of this study is to determined the best definitive radiotherapy dosage for patients with locally advanced 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
646

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_3

Geographic Reach
1 country

3 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

October 15, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

October 17, 2018

Last Update Submit

August 1, 2023

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

chemoradiotherapyesophageal cancerPET/CT

Outcome Measures

Primary Outcomes (2)

  • Overall survival in PET/CT non-responders

    The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.

    2 years

  • Overall survival in ITT population

    The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.

    2 years

Secondary Outcomes (5)

  • Local control rate

    2 years

  • Progression-free survival

    2 years

  • Overall survival in PET/CT responders

    2 years

  • Questionnaire EORTC-QLQ-C30

    2 years

  • Questionnaire EORTC-QLQ-OES18

    2 years

Study Arms (2)

50.4Gy

ACTIVE COMPARATOR

Total radiotherapy dose of 50.4Gy.

Radiation: Radiotherapy

61.2Gy

EXPERIMENTAL

Total radiotherapy dose of 61.2Gy.

Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

Different total radiotherapy dose between two arms.

50.4Gy61.2Gy

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 years; both genders
  • Esophageal squamous cell carcinoma confirmed by pathology.
  • No radiotherapy, chemotherapy or other treatments prior to enrollment
  • Locally advanced esophageal squamous cell carcinoma (T1N1-3M0, T2-4NxM0, TxNxM1 (supraclavicular lymph node metastasis only) (AJCC 8th)
  • Use of an effective contraceptive for adults to prevent pregnancy.
  • No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function. No immunodeficiency.
  • WBC ≥ 3.5\*109/L, Hemoglobin ≥ 9 g/dL, Neutrophils ≥ 1·5\*109/L, Platelet count ≥ 100\*109/L, ALAT and ASAT \< 2·5 \* ULN, TBIL \< 1·5 \* ULN, and Creatinine \< 1·5 \*ULN.
  • ECOG 0-2.
  • Life expectancy of more than 3 months.
  • Agreement of PET/CT accessment at 25-28 radiotherapy fraction.

You may not qualify if:

  • Total radiotherapy dose cannot reach 61.2Gy/34Fx in the condition of the nomal tissue dose complying to the standard criteria.
  • Esophageal perforation, or hematemesis.
  • History of radiotherapy or chemotherapy for esophageal cancer.
  • History of surgery within 28 days before Day 1.
  • History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years).
  • Participation in other interventional clinical trials within 30 days.
  • Pregnant or breast-feeding women or fertile patients who refused to use contraceptives.
  • Drug addiction, alcoholism or AIDS.
  • Uncontrolled seizures or psychiatric disorders.
  • Any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

RECRUITING

Huadong Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Zhu H, Liu Q, Xu H, Mo M, Wang Z, Lu K, Zhou J, Chen J, Zheng X, Ye J, Ge X, Luo H, Liu Q, Deng J, Ai D, Hao S, Zhang J, Tseng IH, Song S, Chen Y, Zhao K. Dose escalation based on 18F-FDG PET/CT response in definitive chemoradiotherapy of locally advanced esophageal squamous cell carcinoma: a phase III, open-label, randomized, controlled trial (ESO-Shanghai 12). Radiat Oncol. 2022 Jul 29;17(1):134. doi: 10.1186/s13014-022-02099-y.

    PMID: 35906623DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal Neoplasms

Interventions

Radiotherapy

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)

Therapeutics

Study Design

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

Study Record Dates

First Submitted

October 17, 2018

First Posted

December 31, 2018

Study Start

October 15, 2018

Primary Completion

October 15, 2023

Study Completion

October 15, 2025

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

CN(3)