N/A
N=31
Radiation Dose Escalation in Esophageal Cancer
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03082586 ↗Enrolled (actual)
31
Serious AEs
6.5%
Results posted
Jul 2020
Primary outcome: Primary: Number of Dose Limiting Toxicities (DLTs) Occurring in Participants — 0; 0; 0; 1 dose limiting toxicity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- radiochemotherapy 1 (Radiation); radiochemotherapy 2 (Radiation); radiochemotherapy 3 (Radiation); radiochemotherapy 4 (Radiation); radiochemotherapy 5 (Radiation); radiochemotherapy 6 (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Dose Limiting Toxicities (DLTs) Occurring in Participants |
0; 0; 0; 1; 0; 2 | — |
| SECONDARY Local Failure |
0; 1; 1; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
- Patients with distant metastasis and life expectancy >/= 3 months are eligible.
- Zubrod 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. 1 0. Induction chemotherapy is allowed.
Exclusion Criteria
- The presence of a fistula.
- Prior radiotherapy that would overlap the radiation fields.
- gastroesophageal junction cancer.
- 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
Data sourced from ClinicalTrials.gov (NCT03082586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.