Clinical trial NCT03936179: High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
Official title: Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival rate
timeFrame: one year
Secondary outcomes:
measure: acute and late toxicities
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Tingfeng Chen, MD
role: STUDY_CHAIR
References: