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Elective or Prophylactic Nodal Irradiation for Esophageal Cancer (ENI or PNI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LANG Jin-yi, The Second People's Hospital of Sichuan
ClinicalTrials.gov Identifier:
NCT01551589
First received: March 4, 2012
Last updated: March 8, 2012
Last verified: March 2012

March 4, 2012
March 8, 2012
March 2012
September 2014   (final data collection date for primary outcome measure)
Local control rate/ Inside irrational field recurrence rate [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
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.
Same as current
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 ] [ Designated as safety issue: No ]
  • 3-year Disease-free survival [ Time Frame: CT scans every 6 months for 3 years ] [ Designated as safety issue: No ]
  • Quality of life(QoL) [ Time Frame: Evaluation of quality of life every week for 3 months ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: CT scans every 3 months for 1 years ] [ Designated as safety issue: No ]
    Evaluation of treatment safety and the quality of life of the patients,the incidence rate of adverse events, especially radiation-induced lung toxicity
Same as current
Not Provided
Not Provided
 
Elective or Prophylactic Nodal Irradiation 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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Squamous Cell Carcinoma
  • Radiation: docetaxel and cisplatin concurrent chemoradiotherapy

    Drug: Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.

    only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8

    PTV-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

  • Radiation: docetaxel and cisplatin

    Prophylactic Irradiation easier involved lymph node region according to different primary tumor sites For upper site: CTV include Bilateral supraclavicular/1/2/4/7 region node,middle site:CTV include 2/4/7/8 region node;lower site:CTV include 4/5/7/8/16/17/18 node. CTV need include the region where the positive node is in the same time.

    Drug: docetaxel and cisplatin The concurrent consists of docetaxel 60-80mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3,repeat every 3 weeks, for 2 cycles.

    IMRT IMRT is administered with chemotherapy from week 1 to week 8 PTV-GTV(primary tumor):66-70Gy/33~35F,once a day, 5 times per week PTV-CTV(Clinical target):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

  • Experimental: Elective nodal irradiation and CCRT
    Intervention: Radiation: docetaxel and cisplatin concurrent chemoradiotherapy
  • Active Comparator: Prophylactic nodal irradiation and CCRT
    Intervention: Radiation: docetaxel and cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
320
September 2015
September 2014   (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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01551589
CSWOG0001, BT-IST-SCCHN-037
Yes
LANG Jin-yi, The Second People's Hospital of Sichuan
LANG Jin-yi
Not Provided
Study Chair: JINYI LANG, M.D. The Second People's Hospital of Sichuan
The Second People's Hospital of Sichuan
March 2012

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