A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer

July 13, 2017 updated by: Tianjin Medical University Cancer Institute and Hospital

A Phase II Trial to Compare Efficacy and Safety of Definitive Radiochemotherapy VS Neoadjuvant Radiochemotherapy Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Stage II-III Esophageal Cancer

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal 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 II 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 stage II-III esophageal Cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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 clinical complete 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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, 7th 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 with hemorrhage or complicated hemorrhage
  3. Other uncontrollable patients who are not suitable for surgery
  4. Pregnant or lactating women
  5. Patients who agree without acknowledgement as a result of psychological, family or social factors
  6. Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade ≥2 peripheral neuropathy
  7. Patients who have ever had malignant tumors other than esophageal cancer
  8. Patients with a history of diabetes for >10 years with unsatisfactory control of blood glucose level
  9. Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery
  10. Others.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Definitive Radiochemotherapy

Concurrent Radiochemotherapy:

Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.
Radiation: Definitive Radiochemotherapy
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day
Procedure: Neoadjuvant Radiochemotherapy
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.
ACTIVE_COMPARATOR: Neoadjuvant Radiochemotherapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame: 5 years
grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.
5 years
Progression-free survival
Time Frame: 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.
3 years
Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer
Time Frame: 2 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.
2 years
Comparison between gross tumor volume (GTV) delineated with ultrasonic endoscopically placed titanium clips and GTV with conventional contouring method in thoracic esophageal cancer
Time Frame: 1 year
patients undergo titanium clips placement on tumor boundaries under ultrasonic endoscopy before radiotherapy CT simulation. According to the clips, the reference GTVs are contoured by one experienced radiation oncologist. With the help of Eclipse treatment planning system, clips on CT are concealed. Two other radiation oncologists of expertise in oesophageal cancer delineate GTVs, defined as conventional GTVs, on the basis of endoscopy and oesophageal barium radiography. The two sets of GTVs are compared and analysed.
1 year
Determination of internal target volume (ITV) of thoracic esophageal cancer by evaluating movement of ultrasonic endoscopically placed titanium clips, with or without swallowing, during radiotherapy simulation
Time Frame: 1 year
after titanium clips placement adjacent to esophageal cancer under ultrasonic endoscopy, clips movements in different borders and different directions are observed during radiotherapy simulation to determine the ITV of esophageal cancer, with or without swallowing.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Study Chair: Qingsong Pang, Doctor, Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

October 29, 2016

First Submitted That Met QC Criteria

November 6, 2016

First Posted (ESTIMATE)

November 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIH-PQS-2016090001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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