Esophageal Cancer, Radiotherapy Side Effect
Conditions
Keywords
Esophageal Cancer, radiotherapy, chemotherapy, Carboplatin
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.
Interventions
DRUGFluorouracil
1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
RADIATIONIntensity modulated radiation therapy
Radiotherapy for 5-6 weeks，50-60Gy
DRUGcarboplatin
Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall objective response rate | up to 24 months | The proportion of partial and complete remission of tumors |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of toxic and side effects above 3 degrees | up to 24 months | The Incidence of toxic and side effects above 3 degrees in overall patients |
Countries
China
Outcome results
None listed