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

Not Applicable

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: docetaxel and cisplatin; Radiation: Involved Field Irradiation(IFI); Radiation: Elective Nodal Irradiation (ENI)

• Registration Number: NCT01551589
• Lead Sponsor: Chengya Chou

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-04
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elective Nodal Irradiation (ENI)	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.
Involved Field Irradiation(IFI)	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.
Involved Field Irradiation(IFI)	docetaxel and cisplatin	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)	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.

Primary Outcome Measures

Name	Time	Method
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	radiation pneumonitis and radiation esophagitis,

Secondary Outcome Measures

Name	Time	Method
3-year Overall survival(OS)	CT scans performed every 6 months for 3 years	3-year Overall survival(OS)
3-year Disease-free survival	CT scans every 6 months for 3 years	3-year Disease-free survival
Quality of life(QoL)	Evaluation of quality of life every week for 3 months	Quality of life(QoL)
Local control rate/ Inside irrational field recurrence rate	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.

Trial Locations

Locations (4)

Guangxi Tumor Hospital; 🇨🇳 Nanning, Guangxi, China

GuiZhou Cancer Hospital; 🇨🇳 Guiyang, Guizhou, China

The Second People's Hospital of Sichuan; 🇨🇳 Chengdu, Sichuan, China

Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University; 🇨🇳 Kunming, Yunnan, China