High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

Shanghai Jiao Tong University

Status: Unknown

Conditions: Esophageal Cancer

Treatments: Radiation: high dose chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03535207

SGH201802

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

high dose chemoradiotherapy

Experimental group

Description:

all eligible patients receive intensity-modulated radiotherapy 50 Gy in 25 fractions over 5 weeks and concurrent paclitaxel and cisplatin once weekly for 5 weeks，followed by hyperfractionated intensity-modulated radiotherapy boost to gross tumor volume concurrent with the same chemotherapy

Treatment:

Radiation: high dose chemoradiotherapy