Clinical trial · Interventional
High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
Phase II Study of High-dose (86 Gy)Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer
NCT03535207CI-TRIAL-00050737unknownN/AClinicalTrials.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)
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high dose chemoradiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- high dose chemoradiotherapy
- description
- all eligible patients receive intensity-modulated radiotherapy 50 Gy in 25 fractions over 5 weeks and concurrent paclitaxel and cisplatin once weekly for 5 weeks,followed by hyperfractionated intensity-modulated radiotherapy boost to gross tumor volume concurrent with the same chemotherapy
- interventionNames
- Radiation: high dose chemoradiotherapy
Primary outcomes (1)
- measure
- overall survival rate
- timeFrame
- one year
- description
- survival time was measured from the date of study enrollment to the date of death or last follow-up
Secondary outcomes (1)
- measure
- toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary squamous cell carcinoma of the esophagus * Age 1 8-75. * Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * No prior radiation to the thorax that would overlap with the current treatment field. * Patients with nodal involvement are eligible * 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. * A signed informed consent must be obtained prior to therapy. * Induction chemotherapy is allowed Exclusion Criteria: * The presence of a fistula. * Prior radiotherapy that would overlap the radiation fields. * gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall. * 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. * Known hypersensitivity to paclitaxel. * Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. * Acquired Immune Deficiency Syndrome. * Conditions precluding medical follow-up and protocol compliance
References
Publications (2)
- 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
- RESULTCooper 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