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

Primary Purpose

Esophageal Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Radiotherapy with simultaneous modulated accelerated boost

Standard dose radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Simultaneous modulated accelerated boost, Standard dose radiotherapy, Chemotherapy, Survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer Hospital, Shantou University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SMART boost

Standard dose RT

Arm Description

Radiotherapy with simultaneous modulated accelerated boost

Standard dose radiotherapy

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Local-regional control

Distant metastasis-free survival

Disease-free survival

Acute and late toxicities using CTCAE v4.0

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

Quality of life as assessed with FACT-E

FACT-E score

Quality of life as measured with EQ-5D

The score of EQ-5D questionnaire

Biomarkers

Full Information

NCT ID

NCT02556762

First Posted

September 17, 2015

Last Updated

December 27, 2021

Sponsor

Chuangzhen Chen

1. Study Identification

Unique Protocol Identification Number

NCT02556762

Brief Title

Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

Acronym

SUMC-EC-002

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 2015 (undefined)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chuangzhen Chen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

Esophageal cancer, Simultaneous modulated accelerated boost, Standard dose radiotherapy, Chemotherapy, Survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SMART boost

Arm Type

Experimental

Arm Description

Radiotherapy with simultaneous modulated accelerated boost

Arm Title

Standard dose RT

Arm Type

Active Comparator

Arm Description

Standard dose radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy with simultaneous modulated accelerated boost

Other Intervention Name(s)

SIB

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Standard dose radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Intervention Description

Chemotherapy: Cisplatin and 5fluorouracil

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Local-regional control

Time Frame

2 years

Title

Distant metastasis-free survival

Time Frame

2 years

Title

Disease-free survival

Time Frame

2 years after randomization

Title

Acute and late toxicities using CTCAE v4.0

Description

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

Time Frame

2 years

Title

Quality of life as assessed with FACT-E

Description

FACT-E score

Time Frame

2 years

Title

Quality of life as measured with EQ-5D

Description

The score of EQ-5D questionnaire

Time Frame

2 years

Title

Biomarkers

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruihong Huang

15989849684@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jianzhou Chen, MD

Phone

86-13417049908

cjzeoeo@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chuangzhen Chen, MD

Organizational Affiliation

Cancer Hospital, Shantou University Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital, Shantou University Medical College

City

Shantou

State/Province

Guangdong

ZIP/Postal Code

515031

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuangzhen Chen, MD

Phone

86-13923995569

stccz@139.com

First Name & Middle Initial & Last Name & Degree

Jianzhou Chen, MD

Phone

86-13417049908

cjzeoeo@gmail.com

First Name & Middle Initial & Last Name & Degree

Chuangzhen Chen, MD

12. IPD Sharing Statement

Learn more about this trial

Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

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