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

NCT ID: NCT03936179

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-04-01

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high dose radiochemotherapy

A total dose of 86 Gy to residual metabolic disease with concurrent chemotherapy

Group Type: EXPERIMENTAL

high dose radiation therapy with concurrent chemotherapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Chen tingfeng

director,department of radiation therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tingfeng Chen, MD

Role: STUDY_CHAIR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai General Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ningning Cheng, MD

Role: CONTACT

ningcnn@163.com

377985364 ext. 8119

Yong Liu, MD

Role: CONTACT

drliuyrt@163.com

37795364 ext. 8119

Facility Contacts

Ningning Cheng, MD

Role: primary

Other Identifiers

SGH201921

Identifier Type: -

Identifier Source: org_study_id