Clinical trial NCT03910634: IMRT With Carboplatin Versus IMRT With Carboplatin and Fluorouracil for Eldly Esophageal Cancer Patients
Official title: IMRT Combined With Carboplatin Versus IMRT Combined With Carboplatin and Fluorouracil in the Treatment of Locally Advanced Esophageal Cancer in Elderly Patients With High Risk of Chemotherapy: a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Radiotherapy Side Effect
Keywords: Esophageal Cancer
radiotherapy
chemotherapy
Carboplatin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 264
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall objective response rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Incidence of toxic and side effects above 3 degrees
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SYSU Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yonghong Hu, Doctor
role: STUDY_DIRECTOR
References: