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
  Purpose

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


Condition Intervention Phase
Esophageal Squamous Cell Carcinoma
Radiation: docetaxel and cisplatin concurrent chemoradiotherapy
Radiation: docetaxel and cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Phase III Trial Comparing Elective to Prophylactic Regional Lymph Node Irradiation for Thoracic Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by The Second People's Hospital of Sichuan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 320
Study Start Date: March 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elective nodal irradiation and CCRT 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

Active Comparator: Prophylactic nodal irradiation and CCRT 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


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551589

Locations
China, Guangxi
Guangxi Tumor Hospital
Nanning, Guangxi, China, 530021
China, Guizhou
GuiZhou Cancer Hospital
Guiyang, Guizhou, China, 550000
China, Sichuan
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China, 610000
China, Yunnan
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
Kunming, Yunnan, China, 652100
Sponsors and Collaborators
LANG Jin-yi
Investigators
Study Chair: JINYI LANG, M.D. The Second People's Hospital of Sichuan
  More Information

No publications provided

Responsible Party: LANG Jin-yi, Chairman of Radiotherapy department, The Second People's Hospital of Sichuan
ClinicalTrials.gov Identifier: NCT01551589     History of Changes
Other Study ID Numbers: CSWOG0001, BT-IST-SCCHN-037
Study First Received: March 4, 2012
Last Updated: March 8, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by The Second People's Hospital of Sichuan:
Esophageal squamous cell carcinoma
Concurrent chemoradiotherapy
Clinical target volume
Safety
Prognosis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014