Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

Esophageal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02556762
• Other study ID #: SUMC-EC-002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Shantou University Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 202
• Est. completion date: December 31, 2024
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• Radiotherapy with simultaneous modulated accelerated boost
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
• Standard dose radiotherapy
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease

Drug:
• PF
Chemotherapy: Cisplatin and 5fluorouracil

Locations

Country	Name	City	State
China	Cancer Hospital, Shantou University Medical College	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chuangzhen Chen

Country where clinical trial is conducted

China, 

Outcome

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