IMRT With Carboplatin Versus IMRT With Carboplatin and Fluorouracil for Eldly Esophageal Cancer Patients

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Radiotherapy Side Effect; Esophageal Cancer

Treatments: Drug: carboplatin; Drug: Fluorouracil; Radiation: Intensity modulated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03910634

GD-Q201807

Details and patient eligibility

About

An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy

Full description

Esophageal cancer is one of the most common malignant tumors in China.To compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy.This trial is an open, single-center, randomized controlled phase II clinical trial.

Enrollment: 264 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age (> 65 years)
• Histologically confirmed esophageal squamous cell carcinoma, the 8th edition of AJCC stage T3-4NxM0 or TxN1-3M0, without surgical indications after consultation by surgeons.
• PS score < 2, Chemotherapy risk score is medium and high risk
• No radical thoracic surgery/chemotherapy/radiotherapy/targeted therapy has been performed in the past.
• Diseases measurable according to RECIST standards
• Hematological examination requires Hb (>90g/L), ANC (>2.0 *109/L) and platelet (>100 *109/L). Serum albumin (>3.0g/dL)
• Serum creatinine < 1.25 times normal upper limit (UNL), or creatinine clearance rate (>60 ml/min). Total bilirubin < upper limit of normal value
• Total bilirubin < the upper limit of normal value, AST (SGOT) and ALT (SGPT) < 2.5 times the upper limit of normal value, ALP < 2.5 times the upper limit of normal value (ULN)
• If exploratory surgery is performed, the patient will recover at least 2 weeks after operation.

Exclusion criteria

• Pregnant or lactating women.
• Patients with fertility without adequate contraceptive measures.
• Anaphylaxis to 5FU and carboplatin is known.
• Anaphylaxis known to exist with any drug in the study
• Other malignant tumors have occurred in the past five years, except cervical carcinoma in situ or non-melanoma skin cancer, which has been properly treated.
• Discovery of esophageal fistula or risk of esophageal bleeding before treatment
• Distant organ metastasis is known
• Symptomatic peripheral neuropathy, according to NCIC-CTC criteria (> grade 2).
• Other serious diseases or medical conditions: Myocardial infarction (in the past six months), severe unstable angina pectoris and congestive heart failure have occurred.
• Severe complications (including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, severe respiratory dysfunction of COPD, cardiac dysfunction of pulmonary heart disease, uncontrolled diabetes mellitus, renal insufficiency and cirrhosis of liver, etc.)
• Gastrointestinal bleeding requires frequent blood transfusion.
• It is known to carry human immunodeficiency virus (HIV) or AIDS.
• Suffering from mental illness
• The known neuropathy is of grade 2 or higher severity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups, including a placebo group

IMRT combined with carboplatin

Experimental group

Description:

Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Treatment:

Radiation: Intensity modulated radiation therapy

Drug: carboplatin

IMRT combined with carboplatin and fluorouracil

Placebo Comparator group

Description:

Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip; Fluorouracil 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks

Treatment:

Radiation: Intensity modulated radiation therapy

Drug: Fluorouracil

Drug: carboplatin