Clinical trial · Interventional
IMRT Tomotherapy for Esophagus Cancer
IMRT Tomotherapy for Esophagus Cancer: A Phase I Feasibility Study in Non-Operative Patients
- 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)
Concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population is quite low. Methods to intensify radiation therapy delivery without increasing local toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients with esophagus cancer.
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 |
|---|---|---|---|
| Esophagus Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT + Concurrent chemotherapy
- description
- 180 cGy daily fractions to a total dose of 5400 cGy to PTV1 and 200 cGy daily fractions to a total dose of 6000 cGy to PTV2. Once a day, five days a week, for approximately 6 weeks. Planned chemotherapy: cisplatin (75 mg/m2) day 1 and 5-FU (1000 mg/m2) days 1-4 on weeks 1, 5, 10, and 14 of therapy. Please note that drug regimens and doses may vary and will be at the discretion of the medical oncologist.
- interventionNames
- Radiation: IMRT
Primary outcomes (1)
- measure
- The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.
- timeFrame
- One year after protocol registration
- description
- The study will be deemed infeasible if one or more of the following results occur: * 15% of patients experience any grade 4 acute toxicity judged to be related to his/her external radiation treatment * within 1 year of protocol registration, \>15% of patients develop any grade 4 late toxicity judged to be related to his/her external radiation treatment * within 1 year of protocol registration, any patient dies from causes judged to be related to his/her external beam radiation treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 * Karnofsky Performance Status of \>= 60 * TNM Stages T1-4, N0-3, M0 * Pathologic confirmation of esophagus cancer * Evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy * Evaluation by surgeon determines that patient is unresectable Exclusion Criteria: * Age \< 18 * Karnofsky Performance Status \< 60 * Radiographic or pathologic evidence of distant metastatic disease (classified as M1b in AJCC staging manual) * Prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy. * Pregnant or lactating, if female.
References
Publications (0)
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