High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Radiation: high dose radiation therapy with concurrent chemotherapy
- Registration Number
- NCT03936179
- Lead Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description high dose radiochemotherapy high dose radiation therapy with concurrent chemotherapy A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method acute and late toxicities 1 year Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4
Trial Locations
- Locations (1)
Shanghai General Hospital
🇨🇳Shanghai, China