Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer (SUMC-EC-002)

February 3, 2024 updated by: Chuangzhen Chen

Phase III Randomized Controlled Trial of Definite Chemoradiotherapy in Patients With Esophageal Cancer: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

202

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shantou, Guangdong, China, 515031
        • Cancer Hospital, Shantou University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMART boost
Radiotherapy with simultaneous modulated accelerated boost
Radiation: Radiotherapy with simultaneous modulated accelerated boost
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
Other Names:
  • SIB
Drug: PF
Chemotherapy: Cisplatin and 5fluorouracil
Active Comparator: Standard dose RT
Standard dose radiotherapy
Drug: PF
Chemotherapy: Cisplatin and 5fluorouracil
Radiation: Standard dose radiotherapy
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local-regional control
Time Frame: 2 years
2 years
Distant metastasis-free survival
Time Frame: 2 years
2 years
Disease-free survival
Time Frame: 2 years after randomization
2 years after randomization
Acute and late toxicities using CTCAE v4.0
Time Frame: 2 years
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.
2 years
Quality of life as assessed with FACT-E
Time Frame: 2 years
FACT-E score
2 years
Quality of life as measured with EQ-5D
Time Frame: 2 years
The score of EQ-5D questionnaire
2 years
Biomarkers
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuangzhen Chen

Investigators

  • Principal Investigator: Chuangzhen Chen, MD, Cancer Hospital, Shantou University Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

March 1, 2022

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimated)

September 22, 2015

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUMC-EC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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