Clinical trial NCT01551589: 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
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Esophageal squamous cell carcinoma
Concurrent chemoradiotherapy
Clinical target volume
Safety
Prognosis
Lead sponsor: The Second People's Hospital of Sichuan
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: radiation pneumonitis and radiation esophagitis
timeFrame: Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years
Secondary outcomes:
measure: 3-year Overall survival(OS)
timeFrame: CT scans performed every 6 months for 3 years
measure: 3-year Disease-free survival
timeFrame: CT scans every 6 months for 3 years
measure: Quality of life(QoL)
timeFrame: Evaluation of quality of life every week for 3 months
measure: Local control rate/ Inside irrational field recurrence rate
timeFrame: 2 year
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Tumor Hospital
state: Guangxi
city: Guiyang
country: China
facility: GuiZhou Cancer Hospital
state: Guizhou
city: Chengdu
country: China
facility: The Second People's Hospital of Sichuan
state: Sichuan
city: Kunming
country: China
facility: Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
state: Yunnan
Study officials:
affiliation: The Second People's Hospital of Sichuan
name: JINYI LANG, M.D.
role: STUDY_CHAIR
References: