Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer

July 25, 2017 updated by: Chengya Chou

Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer

This study examines contrast advantages and disadvantages of elective or prophylactic nodal irradiation in the treatment of esophageal cancer with three-dimensional conformed radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Esophageal lymph node drainage area is rich, according to different sites, easy to metastasis to different regions. For patient underwent concurrent chemoradiotherapy, how reasonable design the clinical target volume of lymph node drainage area has always been controversial, one is to irradiate positive lymph nodes only, the other is to irradiate the easier involved lymph node area according to different sites, in order to contrast advantages and disadvantages of the two kind of target area design，so the study was designed.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

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
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Tumor Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Guizhou Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • The Second People's Hospital of Sichuan
    • Yunnan
      • Kunming, Yunnan, China, 652100
        • Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 80
  2. ECOG performance status 0-2
  3. Weight is not less than 90% of it before treatment
  4. Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III
  5. Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective)
  6. WBC ≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
  7. Platelets ≥ 100X109/L
  8. Hemoglobin ≥ 90g/L(without blood transfusion)
  9. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
  10. Creatinine ≤ 1.5 x upper limit of normal
  11. Sign study-specific informed consent prior to study entry -

Exclusion Criteria:

  1. Multiple primary esophageal tumors
  2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).

  3. Severe, active comorbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
  5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Involved Field Irradiation(IFI)
Involved Field Irradiation(IFI):The clinical target volume of regional lymph node (CTVn) of IFI included the nodal region(s) in which the involved lymph node(s) was/were located.chemothrapy:docetaxel and cisplatin.
Radiation: Involved Field Irradiation(IFI)
Involved Field Irradiation(IFI):only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8PTV-GTV（primary tumor）：66-70Gy/33~35F，once a day, 5 times per week PTV-CTV（Clinical target,primary tumor extended 3cm in Axial）：50-56Gy/33~35f，once a day, 5 times per week PTV-GTVnd（positive node）：66-70Gy/33~35F，once a day, 5 times per week.
Drug: docetaxel and cisplatin
Drug: docetaxel and cisplatin.Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.
Other Names:
  • chemothrrapy
ACTIVE_COMPARATOR: Elective Nodal Irradiation (ENI)
Elective Nodal Irradiation (ENI):The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17 were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.chemothrapy:docetaxel and cisplatin.
Drug: docetaxel and cisplatin
Drug: docetaxel and cisplatin.Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.
Other Names:
  • chemothrrapy
Radiation: Elective Nodal Irradiation (ENI)
The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiation pneumonitis and radiation esophagitis
Time Frame: Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years
radiation pneumonitis and radiation esophagitis,
Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year Overall survival(OS)
Time Frame: CT scans performed every 6 months for 3 years
3-year Overall survival(OS)
CT scans performed every 6 months for 3 years
3-year Disease-free survival
Time Frame: CT scans every 6 months for 3 years
3-year Disease-free survival
CT scans every 6 months for 3 years
Quality of life(QoL)
Time Frame: Evaluation of quality of life every week for 3 months
Quality of life(QoL)
Evaluation of quality of life every week for 3 months
Local control rate/ Inside irrational field recurrence rate
Time Frame: 2 year
Evaluation after treatment 3 months and two years in the tumor local control and key observation radiation fields inside and outside the tumor recurrence and lymph node metastatic rate. To guide the rational clinical target volume of lymph node of esophageal cancer underwnet concurrent chemoradiotherapy and to Prolong the survival time, improve the quality of life of the patients.
2 year

Collaborators and Investigators

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

Sponsor

Chengya Chou

Investigators

  • Study Chair: JINYI LANG, M.D., The Second People's Hospital of Sichuan

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

March 1, 2012

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

March 4, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSWOG0001
  • BT-IST-SCCHN-037 (OTHER: BT-IST-SCCHN-037)

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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