Efficacy and Safety of Neo-CRT Followed Surgery Compared With Definitive CRT in Patients With Initial Unresectable ESO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-08-31

Brief Summary

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Definitive chemoradiotherapy(CRT) has been regarded as a standard of care for patients with unresectable locally advanced esophageal cancer. Patients who are sensitive to CRT can achieve significantly down staging. Whether this part of patients could benefit from further surgical treatment remains unknown. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive CRT versus neo-CRT plus radical resection in patients who achieved down staging after neo-CRT for stage T4NxM0 esophageal Cancer.

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Detailed Description

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1. Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who down stage from inoperable to operable after neoadjuvant treatment;
2. Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;
3. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.

Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2), 1st/8th/15th/22nd day

Conditions

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Unresectable Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Definitive Radiochemotherapy

Concurrent Radiochemotherapy:

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.

Group Type EXPERIMENTAL

Definitive Radiochemotherapy

Intervention Type RADIATION

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

Neoadjuvant Radiochemotherapy followed by surgery

Intervention Type PROCEDURE

Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Neoadjuvant Radiochemotherapy followed by surgery

Concurrent Radiochemotherapy:

Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Group Type ACTIVE_COMPARATOR

Definitive Radiochemotherapy

Intervention Type RADIATION

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

Neoadjuvant Radiochemotherapy followed by surgery

Intervention Type PROCEDURE

Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Interventions

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Definitive Radiochemotherapy

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

Intervention Type RADIATION

Neoadjuvant Radiochemotherapy followed by surgery

Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Thoracic esophageal cancer patients or esophagogastric junction cancer patients, with locally advanced unresectable tumor, clinically identified before treatment as T4bNxM0 or lymph node metastases (LNM)invading adjacent structures according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 8th ed.
2. Initial unresectable assessed by surgeon.
3. Patients able to tolerate surgery.
4. Untreated patients who have not received any antitumor therapy.
5. Life expectancy \> 6 months.
6. Age: 18-70 years.
7. White blood cell count ≥4.0×10\^9/L, ANC(absolute neutrophil count) ≥1.5×10\^9/L, thrombocyte count ≥100×10\^9/L, hemoglobin ≥90 g/L; normal liver and kidney functions.
8. WHO PS(Performance Status): 0-1.
9. Patients who understood the study and gave signed informed consent.

Exclusion Criteria

1. Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery.
2. Patients with hemorrhage or complicated hemorrhage.
3. Other uncontrollable patients who are not suitable for surgery.
4. Patients who deny to accept surgery.
5. Pregnant or lactating women.
6. Patients who agree without acknowledgement as a result of psychological, family or social factors.
7. Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade ≥2 peripheral neuropathy.
8. Patients who have ever had malignant tumors other than esophageal cancer.
9. Patients with a history of diabetes for \>10 years with unsatisfactory control of blood glucose level.
10. Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery.
11. Patients with severe infection.
12. Patients with uncontrolled diabetes, random blood glucose \> 200mg/L, fasting glucose \>140mg/L.
13. Patients with other severe disease, such as myocardial infarction in the last 6 months.
14. Patients who participate in other clinical trials right now or in the last 4 weeks.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No