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

Primary Purpose

Esophageal Cancer, Radiotherapy Side Effect

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fluorouracil

Intensity modulated radiation therapy

carboplatin

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Cancer, radiotherapy, chemotherapy, Carboplatin

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept 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.

Sites / Locations

SYSU Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMRT combined with carboplatin

IMRT combined with carboplatin and fluorouracil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall objective response rate

The proportion of partial and complete remission of tumors

Secondary Outcome Measures

Incidence of toxic and side effects above 3 degrees

The Incidence of toxic and side effects above 3 degrees in overall patients

Full Information

NCT ID

NCT03910634

First Posted

April 8, 2019

Last Updated

April 9, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03910634

Brief Title

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

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 9, 2019 (Anticipated)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Radiotherapy Side Effect

Keywords

Esophageal Cancer, radiotherapy, chemotherapy, Carboplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMRT combined with carboplatin

Arm Type

Experimental

Arm Description

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

Arm Title

IMRT combined with carboplatin and fluorouracil

Arm Type

Placebo Comparator

Arm 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

Intervention Type

Drug

Intervention Name(s)

Fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Intensity modulated radiation therapy

Other Intervention Name(s)

IMRT

Intervention Description

Radiotherapy for 5-6 weeks，50-60Gy

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Primary Outcome Measure Information:

Title

Overall objective response rate

Description

The proportion of partial and complete remission of tumors

Time Frame

up to 24 months

Secondary Outcome Measure Information:

Title

Incidence of toxic and side effects above 3 degrees

Description

The Incidence of toxic and side effects above 3 degrees in overall patients

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yonghong Hu, Doctor

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Director

Facility Information:

Facility Name

SYSU Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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