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Active, not recruitingNCT02556762SUMC-EC-002Updated Feb 6, 2024

Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

A Phase 3 interventional study of Radiotherapy with simultaneous modulated accelerated boost and Standard dose radiotherapy in Esophageal Cancer, sponsored by Chuangzhen Chen. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Chuangzhen Chen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Esophageal cancer
  • Simultaneous modulated accelerated boost
  • Standard dose radiotherapy
  • Chemotherapy
  • Survival
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 202 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Chuangzhen Chen is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
202 participants (estimated)

Study arms

  • Experimental
    SMART boost

    Radiotherapy with simultaneous modulated accelerated boost

    Radiation: Radiotherapy with simultaneous modulated accelerated boost · Drug: PF

  • Active comparator
    Standard dose RT

    Standard dose radiotherapy

    Radiation: Standard dose radiotherapy · Drug: PF

Interventions

  • RadiationRadiotherapy with simultaneous modulated accelerated boost

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

    Also known as: SIB

  • RadiationStandard dose radiotherapy

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

  • DrugPF

    Chemotherapy: Cisplatin and 5fluorouracil

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 2 years

Secondary outcomes

  1. Local-regional control

    Time frame: 2 years

  2. Distant metastasis-free survival

    Time frame: 2 years

  3. Disease-free survival

    Time frame: 2 years after randomization

  4. Acute and late toxicities using CTCAE v4.0

    The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.

    Time frame: 2 years

  5. Quality of life as assessed with FACT-E

    FACT-E score

    Time frame: 2 years

  6. Quality of life as measured with EQ-5D

    The score of EQ-5D questionnaire

    Time frame: 2 years

  7. Biomarkers

    Time frame: 2 years

07

Study locations

1 site
  • Cancer Hospital, Shantou University Medical College
    Shantou, Guangdong 515031, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02556762
Lead sponsor
Chuangzhen Chen
Responsible party
Chuangzhen Chen (M.D, Shantou University Medical College) — Sponsor-investigator
First posted
Sep 22, 2015
Start date
Aug 2015
Primary completion
Mar 1, 2022
Completion
Dec 31, 2024 (estimated)
Last update
Feb 6, 2024

Study contacts

Chuangzhen Chen, MD
principal investigator · Cancer Hospital, Shantou University Medical College

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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