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

NCT03708042 | Unknown Phase 3 DMC

• 1 other identifier: ESO20181012
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage II Esophageal Cancer; Stage III Esophageal Cancer

Keywords

Neoadjuvant Chemoradiation; Definitive Chemoradiation; Clinical complete response

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy

  5 years

Secondary Outcomes (3)

• Progression-free survival

  3 years

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  5 years

• Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer

  3 years

Study Arms (2)

Definitive Radiochemotherapy

EXPERIMENTAL

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

Combination Product: Definitive Radiochemotherapy

Neoadjuvant Radiochemotherapy

ACTIVE COMPARATOR

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

Combination Product: Neoadjuvant Radiochemotherapy

Interventions

Definitive Radiochemotherapy COMBINATION_PRODUCT

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

Definitive Radiochemotherapy

Neoadjuvant Radiochemotherapy COMBINATION_PRODUCT

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Untreated patients who have not received any antitumor therapy
• Life expectancy \>6 months
• Age: 18-70 years
• 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
• WHO PS(Performance Status): 0-1
• Patients who understood the study and gave signed informed consent

You may not qualify if:

• Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery;
• Patients who suffered from hemorrhage or complicated hemorrhage;
• Other uncontrollable patients who are not suitable for surgery;
• Female patients in pregnancy or lactation;
• Patients who agree without acknowledgement due to psychic, family or social factors;
• Patients who suffered from peripheral neuropathy, with CTC grade ≥2;
• Patients who ever suffered from other types of malignant tumor other than esophagus cancer;
• Patients who have diabetes history over 10 yrs and blood glucose level is not satisfyingly controlled;
• 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;
• Others.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Sun Yat-sen University: collaborator
• Peking University Cancer Hospital & Institute: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Ping Wang, PHD & MD

  Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Dong Qian, PHD & MD

CONTACT

+862223341405; qiankeyu1984@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share