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 locoregionally advanced esophageal cancer
Detailed description
The Radiation Therapy Oncology Group (RTOG) 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional failure remains problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the standard dose (50-50.4 Gy) chemoradiotherapy . Our previous phase I radiation dose escalation trial established the maximum tolerated dose of 86 Gy 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 chemoradiotherapy
Radiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy after high dose chemoradiation is optional.
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
* 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
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 |
|---|---|---|
| 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
Backup ContactYong Liu, MD
Outcome results
None listed