Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer
NCT ID: NCT02556762
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
202 participants
INTERVENTIONAL
2015-08-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SMART boost
Radiotherapy with simultaneous modulated accelerated boost
Radiotherapy with simultaneous modulated accelerated boost
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
PF
Chemotherapy: Cisplatin and 5fluorouracil
Standard dose RT
Standard dose radiotherapy
Standard dose radiotherapy
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease
PF
Chemotherapy: Cisplatin and 5fluorouracil
Interventions
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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
PF
Chemotherapy: Cisplatin and 5fluorouracil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Chuangzhen Chen
OTHER
Responsible Party
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Chuangzhen Chen
M.D
Principal Investigators
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Chuangzhen Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, Shantou University Medical College
Locations
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Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, China
Countries
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Other Identifiers
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SUMC-EC-002
Identifier Type: -
Identifier Source: org_study_id
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