Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer

Phase 3

Active, not recruiting

• Conditions: Esophageal Cancer
• Interventions: Radiation: Radiotherapy with simultaneous modulated accelerated boost; Radiation: Standard dose radiotherapy; Drug: PF

• Registration Number: NCT02556762
• Lead Sponsor: Chuangzhen Chen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Primary Completion: 2022-03-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose RT	PF	Standard dose radiotherapy
SMART boost	PF	Radiotherapy with simultaneous modulated accelerated boost
SMART boost	Radiotherapy with simultaneous modulated accelerated boost	Radiotherapy with simultaneous modulated accelerated boost
Standard dose RT	Standard dose radiotherapy	Standard dose radiotherapy

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Hospital, Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China