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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chengya Chou, The Second People's Hospital of Sichuan
ClinicalTrials.gov Identifier:
NCT01551589
First received: March 4, 2012
Last updated: July 25, 2017
Last verified: July 2017
March 4, 2012
July 25, 2017
March 2012
July 2017   (Final data collection date for primary outcome measure)
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,
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.
Complete list of historical versions of study NCT01551589 on ClinicalTrials.gov Archive Site
  • 3-year Overall survival(OS) [ Time Frame: CT scans performed every 6 months for 3 years ]
    3-year Overall survival(OS)
  • 3-year Disease-free survival [ Time Frame: CT scans every 6 months for 3 years ]
    3-year Disease-free survival
  • Quality of life(QoL) [ Time Frame: Evaluation of quality of life every week for 3 months ]
    Quality of life(QoL)
  • 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.
  • 3-year Overall survival(OS) [ Time Frame: CT scans performed every 6 months for 3 years ]
  • 3-year Disease-free survival [ Time Frame: CT scans every 6 months for 3 years ]
  • Quality of life(QoL) [ Time Frame: Evaluation of quality of life every week for 3 months ]
  • Safety and Tolerability [ Time Frame: CT scans every 3 months for 1 years ]
    Evaluation of treatment safety and the quality of life of the patients,the incidence rate of adverse events, especially radiation-induced lung toxicity
Not Provided
Not Provided
 
Involved Field Irradiation (IFI) Versus Elective Nodal Irradiation (ENI) for Esophageal Cancer
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Esophageal Squamous Cell Carcinoma
  • 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 Name: 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.
  • 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.
    Interventions:
    • Radiation: Involved Field Irradiation(IFI)
    • Drug: docetaxel and cisplatin
  • 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.
    Interventions:
    • Drug: docetaxel and cisplatin
    • Radiation: Elective Nodal Irradiation (ENI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
July 2017
July 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01551589
CSWOG0001
BT-IST-SCCHN-037 ( Other Identifier: BT-IST-SCCHN-037 )
Yes
Not Provided
Not Provided
Chengya Chou, The Second People's Hospital of Sichuan
Chengya Chou
Not Provided
Study Chair: JINYI LANG, M.D. The Second People's Hospital of Sichuan
The Second People's Hospital of Sichuan
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP