Clinical trial · Interventional
Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer
Phase III Randomized Controlled Trial of Definite Chemoradiotherapy in Patients With Esophageal Cancer: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy
NCT02556762CI-TRIAL-00073666SUMC-EC-002unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF | Drug | — | UNRESOLVED |
| Radiotherapy with simultaneous modulated accelerated boost | Radiation | — | UNRESOLVED |
| Standard dose radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SMART boost
- description
- Radiotherapy with simultaneous modulated accelerated boost
- interventionNames
- Radiation: Radiotherapy with simultaneous modulated accelerated boost
- Drug: PF
- type
- ACTIVE_COMPARATOR
- label
- Standard dose RT
- description
- Standard dose radiotherapy
- interventionNames
- Radiation: Standard dose radiotherapy
- Drug: PF
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.