Esophageal Cancer
Conditions
Brief summary
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer
Detailed description
Standard dose chemoradiotherapy (SCRT) results in poor local control for localregionally advanced esopgageal cancer patients. Most local failures occur in the gross tumor volume.\[F-18\]-fluorodeoxyglucose (FDG) PET/CT can identify residual metabolic disease (RMD). Hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. Our previous phase I radiation dose escalation trial demonstrated that 86 Gy could be safely delivered to the RMD with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.
Interventions
RADIATIONhigh dose radiation therapy with concurrent chemotherapy
standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have FDG-avid and histologically or cytologically proven esophageal cancer. * 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. * No prior radiation to the thorax that would overlap with the current treatment field. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival rate | one year | survival time was measured from the date of study enrollment to the date of death or last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute and late toxicities | 1 year | Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4 |
Countries
China
Contacts
Primary ContactNingning Cheng, MD
Backup ContactYong Liu, MD
Outcome results
None listed