High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Phase II Trial of High Dose PET/CT-guided Radiation Therapy With Concurrent Weekly Carboplatin and Paclitaxel in Localregionally Advanced Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03936179
• Other study ID #: SGH201921
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2021
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Ningning Cheng, MD
• Phone: 377985364
• Email: ningcnn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Radiation:
• high 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

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival rate	survival time was measured from the date of study enrollment to the date of death or last follow-up	one year
Secondary	acute and late toxicities	Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4	1 year