NCT02556762

Brief Summary

This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

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, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

6.6 years

First QC Date

September 17, 2015

Last Update Submit

February 3, 2024

Conditions

Esophageal Cancer

Keywords

Esophageal cancerSimultaneous modulated accelerated boostStandard dose radiotherapyChemotherapySurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    2 years

Secondary Outcomes (7)

  • Local-regional control

    2 years

  • Distant metastasis-free survival

    2 years

  • Disease-free survival

    2 years after randomization

  • Acute and late toxicities using CTCAE v4.0

    2 years

  • Quality of life as assessed with FACT-E

    2 years

  • +2 more secondary outcomes

Study Arms (2)

SMART boost

EXPERIMENTAL

Radiotherapy with simultaneous modulated accelerated boost

Radiation: Radiotherapy with simultaneous modulated accelerated boostDrug: PF

Standard dose RT

ACTIVE COMPARATOR

Standard dose radiotherapy

Radiation: Standard dose radiotherapyDrug: PF

Interventions

Radiotherapy with simultaneous modulated accelerated boostRADIATION

Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases

Also known as: SIB
SMART boost
Standard dose radiotherapyRADIATION

Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease

Standard dose RT
PFDRUG

Chemotherapy: Cisplatin and 5fluorouracil

SMART boostStandard dose RT

Eligibility Criteria

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

You may qualify if:

  • Histologic proof of primary squamous cell carcinoma of the esophagus.
  • Primary disease at cervical, upper or middle thoracic esophagus
  • T1-4, N any, M0 (except supraclavicular lymph node).
  • Age≥18 \& ≤75.
  • ECOG score 0-2.
  • Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl.
  • Adequate liver function.
  • Patients with prior malignancy are eligible if disease-free ≥ 5 years.
  • No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery.
  • Signed study-specific informed consent form prior to study entry.

You may not qualify if:

  • Patients with tracheo-esophageal fistula.
  • Patients with invasion into mucosa of trachea or major bronchi.
  • Patients with uncontrolled serious medical or mental illnesses.
  • Prior RT that would result in overlap of planned RT fields.
  • Pregnancy or women of childbearing potential and men who are sexually active
  • Women who are breastfeeding a baby.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Shantou University Medical College

Shantou, Guangdong, 515031, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Chuangzhen Chen, MD

    Cancer Hospital, Shantou University Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 22, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2022

Study Completion

December 31, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

CN(1)