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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03910634
• Other study ID #: GD-Q201807
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: April 9, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 264
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Radiotherapy Side Effect

Intervention

Drug:
• Fluorouracil
1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks

Radiation:
• Intensity modulated radiation therapy
Radiotherapy for 5-6 weeks,50-60Gy

Drug:
• carboplatin
Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Locations

Country	Name	City	State
China	SYSU Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall objective response rate	The proportion of partial and complete remission of tumors	up to 24 months
Secondary	Incidence of toxic and side effects above 3 degrees	The Incidence of toxic and side effects above 3 degrees in overall patients	up to 24 months