Phase II/III Study Compare Adjuvant Chemoradiotherapy, Radiotherapy and Surgery Alone for Esophageal Carcinoma

April 2, 2020 updated by: Zefen Xiao

A Phase II/III Study of Adjuvant Chemoradiotherapy, Radiotherapy After Surgery Versus Surgery Alone in Patients With Stage ⅡB-Ⅲ Esophageal Carcinoma

This phase III trial is studying how well the combination of chemoradiation or radiation works in resected locally advanced cancer of the esophagus or gastroesophageal junction.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have always been playing an important role because of the poor survival rates of the patients in stage ⅡB[UICC 7th edition] -Ⅲ[UICC 7th edition] who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stageⅡB-Ⅲ of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is merely about 28.4% ,and locoregional lymph nodes metastases is responsible for the main cause of failure. While we have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases and stage Ⅲ disease (UICC 6th edition) under the conventional 2-dimensional radiotherapy methods in subset analysis of prospective randomized clinical trial. For patients with positive lymph nodes, 5 year survival after surgery alone was 28.4%, median overall survival was 24 months, recurrence patterns were 34.6% in mediastinal lymph nodes，13.3% in supraclavicular lymph nodes，10% in abdominal lymph nodes. Distant metastases occurred in 21% patients. Adjuvant radiotherapy significantly reduced the recurrence in mediastinal lymph nodes(13.4%), supraclavicular lymph nodes (6.1%). However distant metastases rate increased to 30.7%. Chemotherapy may be vital for these patients. Chen reported that 5 year overall survival rates for the chemoradiotherapy group and radiotherapy group were 47.4% and 38.6% (P=0.03). Based on our studies, treatment failure occurred in 8% patients because of celiac metastases. Small radiation field by omitting celiac drainage region may ensure patients to accept 2 cycles of concurrent chemotherapy for lower toxicity.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 2
  • Phase 3

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
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Science

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 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. KPS≥70
  2. Diagnosis of stage ⅡB or Ⅲ thoracic esophageal cancer
  3. Complete resection
  4. Adequate organ function:

Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension

Exclusion Criteria:

  1. Uncontrolled diabetes
  2. Interval between surgery and adjuvant therapy more than 3 months
  3. Sign of recurrence on CT scan or ultrasound or PET-CT No palpable subclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
  4. With Weight loss greater than 10% from baseline
  5. With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  6. Be pregnant

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Surgery alone
No adjuvant treatment after radical resection is developed in this arm
Experimental: Adjuvant Chemoradiation
Adjuvant chemoradiation after radical resection is developed in this arm
Radiation: Adjuvant Chemoradiation
Patients receive Paclitaxel 135-150mg/m2 (D1 and D29) and Cisplatin or Nedaplatin 50-75mg/m2 (D1 and D29) every 4 weeks, concurrent with radiotherapy. Prophylactic polyethylene glycol recombinant human G-CSF is administered 48 hours after chemotherapy. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Drug: Paclitaxel
135-150mg/m2 (D1 and D29)
Drug: Cisplatin or Nedaplatin
50-75mg/m2 (D1 and D29)
Active Comparator: Adjuvant Radiation
Adjuvant radiation after radical resection is developed in this arm
Radiation: Adjuvant Radiation
Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: up to 3 years
From the date of randomization to the date of first failure or last follow-up
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 5 years
From the date of randomization to the date of death or last follow-up
up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 5 years
From the date of randomization to the date of death or last follow-up
up to 5 years

Collaborators and Investigators

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

Sponsor

Zefen Xiao

Investigators

  • Principal Investigator: Zefen Xiao, MD, Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Science

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

Helpful Links

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 (Actual)

October 1, 2014

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-090/880

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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