Clinical trial · Interventional
Simultaneous Integrated Boost (SIB) in Esophageal Cancer
Phase I/II Study of Evaluating the Safety and Efficacy of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer
NCT01102088CI-TRIAL-00045232completedPhase 1ClinicalTrials.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)
The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given in combination with chemotherapy in patients with esophageal cancer that cannot be removed by surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation + Chemotherapy
- description
- Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions. For the phase II part of the study once the MTD has been achieved proton therapy will be allowed. Treatment dose will be identical to that of the photon treatment where the PTV is treated to 50.4 Gy(RBE) (RBE=1.1) while the CTV is boosted to 63 Gy(RBE) in 28 fractions. Chemotherapy Administration: Schedule of chemotherapy, and modifications of chemotherapy drugs during chemoradiation treatment will be at the discretion of the treating medical oncologist per their standard of practice and with consideration to standard chemotherapy drugs in the treatment of esophageal cancer.
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Simultaneous Integrated Boost (SIB)
- timeFrame
- 8 Weeks
- description
- MDT defined as CTCAE 3 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction. 2. Age \>/= 18. 3. Patients must be deemed unresectable disease or considered for a selective surgical approach (where surgery is delay if a patient achieves a complete response) as determined by the multidisciplinary evaluation or patient is not considered operable due to medical reasons. 4. Patients with distant metastasis and life expectancy \>/= 3 months are eligible. 5. ECOG Performance Status 0-2 6. No prior radiation to the thorax that would overlap with the current treatment field, prior radiation to other areas is allowed. 7. Patients with nodal involvement are eligible 8. Adequate bone marrow, and renal functions as assessed by the following: Hemoglobin \>/= 9.0 g/dl, Platelet count \>/= 100,000/mm\^3, Creatinine \</=1.5 times ULN 9. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures. 10. Patients (men and women) of childbearing potential must use effective method of birth control throughout their participation in this study. 11. Induction chemotherapy is allowed. Exclusion Criteria: 1. Patients with T1, N0 lesions. 2. Patients with a TE fistula or direct invasion into the mucosa of the trachea or major bronchi. Bronchoscopy is encouraged if a TE fistula is suspected. The presence of a fistula will exclude a patient from this study. 3. Prior surgery or radiotherapy for esophageal or gastroesophageal junction cancer. 4. Prior radiotherapy that would overlap the anticipated study treatment fields. 5. Patients with active second malignancy are allowed as long as it is determined that the treatment of esophageal cancer is a higher priority through proper subspecialty consultations. 6. Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with the study requirements. 7. Known hypersensitivity to docetaxel, 5-FU. 8. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
References
Publications (1)
- DERIVEDChen D, Menon H, Verma V, Seyedin SN, Ajani JA, Hofstetter WL, Nguyen QN, Chang JY, Gomez DR, Amini A, Swisher SG, Blum MA, Younes AI, Barsoumian HB, Erasmus JJ, Lee JH, Bhutani MS, Hess KR, Minsky BD, Welsh JW. Results of a Phase 1/2 Trial of Chemoradiotherapy With Simultaneous Integrated Boost of Radiotherapy Dose in Unresectable Locally Advanced Esophageal Cancer. JAMA Oncol. 2019 Nov 1;5(11):1597-1604. doi: 10.1001/jamaoncol.2019.2809. PMID 31529018