A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer

Phase 3

• Conditions: Stage II Esophageal Cancer; Stage III Esophageal Cancer
• Interventions: Combination Product: Neoadjuvant Radiochemotherapy; Combination Product: Definitive Radiochemotherapy

• Registration Number: NCT03708042
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase Ⅲ multicenter clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response (CCR) after neoadjuvant radiochemotherapy for resectable locally advanced esophageal cancer.

Detailed Description

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 achieved clinical complete response 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. Compare the relationship and consistency between pathological complete response of endoscopic biopsy specimens after neoadjuvant treatment and pathological complete response of surgical specimens in neoadjuvant radiochemotherapy plus radical resection group;

4. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.

5. Clinical Complete Response After Neoadjuvant Treatment: Endoscope biopsy pathologic diagnosis indicate pathologic complete response after Neoadjuvant treatment; upper gastrointestinal/chest CT and symptom assessment indicate major response after Neoadjuvant treatment (Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2), 1st/8th/15th/22nd day

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-15
• Last Update Submitted: 2018-10-15
• Study First Posted: 2018-10-16
• Last Update Posted: 2018-10-16
• Study Start: 2018-12-01
• Primary Completion: 2021-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Thoracic esophageal cancer patients or esophagocardial cancer patients, with locally advanced resectable tumor, clinically identified before treatment as T1-3N+M0 according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 8th ed.
2. Untreated patients who have not received any antitumor therapy
3. Life expectancy >6 months
4. Age: 18-70 years
5. White blood cell count ≥4.0×109/l, ANC(absolute neutrophil count) ≥1.5×109/l, thrombocyte count ≥1011/l, hemoglobin ≥90 g/l; normal liver and kidney functions
6. WHO PS(Performance Status): 0-1
7. 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 who suffered from hemorrhage or complicated hemorrhage;
3. Other uncontrollable patients who are not suitable for surgery;
4. Female patients in pregnancy or lactation;
5. Patients who agree without acknowledgement due to psychic, family or social factors;
6. Patients who suffered from peripheral neuropathy, with CTC grade ≥2;
7. Patients who ever suffered from other types of malignant tumor other than esophagus cancer;
8. Patients who have diabetes history over 10 yrs and blood glucose level is not satisfyingly controlled;
9. Patients who suffer from serious malfunction of heart, lung, liver or kidney, hemotopathy, immune system disease or cachexia and therefore can't tolerate chemotherapy or surgery;
10. Others.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Radiochemotherapy	Neoadjuvant Radiochemotherapy	Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
Definitive Radiochemotherapy	Definitive Radiochemotherapy	Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	3 years	Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy
Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer	3 years	In the group of neoadjuvant radiochemotherapy plus surgery, we will compare the pathological diagnosis between specimens of endoscopic biopsy after neoadjuvant treatment and surgically resected.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	5 years	grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.