Clinical trial · Interventional
Radiation Dose Escalation in Esophageal Cancer
Phase I Trial of Radiation Dose Escalation With Concurrent Weekly Cisplatin and Paclitaxel in Patients With Esophageal Cancer
NCT03082586CI-TRIAL-00049074completedN/AResults postedClinicalTrials.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 aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP \& Paclitaxel) in patients with inoperable or medically unresectable esophageal 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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiochemotherapy 1 | Radiation | — | UNRESOLVED |
| radiochemotherapy 2 | Radiation | — | UNRESOLVED |
| radiochemotherapy 3 | Radiation | — | UNRESOLVED |
| radiochemotherapy 4 | Radiation | — | UNRESOLVED |
| radiochemotherapy 5 | Radiation | — | UNRESOLVED |
| radiochemotherapy 6 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- radiochemotherapy 1
- description
- Patients will be treated with radiation therapy 57.2 Gy.
- interventionNames
- Radiation: radiochemotherapy 1
- type
- EXPERIMENTAL
- label
- radiochemotherapy 2
- description
- Patients will be treated with radiation therapy 64.4 Gy.
- interventionNames
- Radiation: radiochemotherapy 2
- type
- EXPERIMENTAL
- label
- radiochemotherapy 3
- description
- Patients will be treated with radiation therapy 71.6 Gy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed primary squamous cell carcinoma of the esophagus 2. Age 1 8-75. 3. Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. 4. Patients with distant metastasis and life expectancy \>/= 3 months are eligible. 5. Zubrod performance status 0 to 2 6. No prior radiation to the thorax that would overlap with the current treatment field. 7. Patients with nodal involvement are eligible 8. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</=1 .5 times ULN. 9. A signed informed consent must be obtained prior to therapy. 1 0. Induction chemotherapy is allowed. Exclusion Criteria: 1. The presence of a fistula. 2. Prior radiotherapy that would overlap the radiation fields. 3. gastroesophageal junction cancer. 4. Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. 5. Known hypersensitivity to paclitaxel. 6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. 7. Acquired Immune Deficiency Syndrome. 8. Conditions precluding medical follow-up and protocol compliance
References
Publications (2)
- BACKGROUNDCooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623. PMID 10235156
- BACKGROUNDHerskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403. PMID 1584260