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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Involved Field Irradiation(IFI)

docetaxel and cisplatin

Elective Nodal Irradiation (ENI)

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Esophageal squamous cell carcinoma, Concurrent chemoradiotherapy, Clinical target volume, Safety, Prognosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Multiple primary esophageal tumors
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).
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.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Sites / Locations

Guangxi Tumor Hospital
GuiZhou Cancer Hospital
The Second People's Hospital of Sichuan
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Involved Field Irradiation(IFI)

Elective Nodal Irradiation (ENI)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

radiation pneumonitis and radiation esophagitis

radiation pneumonitis and radiation esophagitis,

Secondary Outcome Measures

3-year Overall survival(OS)

3-year Disease-free survival

Quality of life(QoL)

Local control rate/ Inside irrational field recurrence rate

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.

Full Information

NCT ID

NCT01551589

First Posted

March 4, 2012

Last Updated

July 25, 2017

Sponsor

Chengya Chou

1. Study Identification

Unique Protocol Identification Number

NCT01551589

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chengya Chou

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinoma, Concurrent chemoradiotherapy, Clinical target volume, Safety, Prognosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Involved Field Irradiation(IFI)

Arm Type

Experimental

Arm Description

Arm Title

Elective Nodal Irradiation (ENI)

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Involved Field Irradiation(IFI)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

docetaxel and cisplatin

Other Intervention Name(s)

chemothrrapy

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Elective Nodal Irradiation (ENI)

Intervention Description

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.

Primary Outcome Measure Information:

Title

radiation pneumonitis and radiation esophagitis

Description

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

Secondary Outcome Measure Information:

Title

3-year Overall survival(OS)

Description

3-year Overall survival(OS)

Time Frame

CT scans performed every 6 months for 3 years

Title

3-year Disease-free survival

Description

3-year Disease-free survival

Time Frame

CT scans every 6 months for 3 years

Title

Quality of life(QoL)

Description

Quality of life(QoL)

Time Frame

Evaluation of quality of life every week for 3 months

Title

Local control rate/ Inside irrational field recurrence rate

Description

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 and ≤ 80 ECOG performance status 0-2 Weight is not less than 90% of it before treatment Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective) WBC ≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L Platelets ≥ 100X109/L Hemoglobin ≥ 90g/L(without blood transfusion) AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal Creatinine ≤ 1.5 x upper limit of normal Sign study-specific informed consent prior to study entry - Exclusion Criteria: Multiple primary esophageal tumors 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). 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. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JINYI LANG, M.D.

Organizational Affiliation

The Second People's Hospital of Sichuan

Official's Role

Study Chair

Facility Information:

Facility Name

Guangxi Tumor Hospital

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

GuiZhou Cancer Hospital

City

Guiyang

State/Province

Guizhou

ZIP/Postal Code

550000

Country

China

Facility Name

The Second People's Hospital of Sichuan

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610000

Country

China

Facility Name

Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

652100

Country

China

12. IPD Sharing Statement

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

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