Elective or Prophylactic Nodal Irradiation for Esophageal Cancer (ENI or PNI)
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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 |
- 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.
- 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 |
Inclusion Criteria:
- Age ≥ 18 and ≤ 80
- ECOG performance status 0-2
- Weight is not less than 90% of it before treatment
- Histologically proven primary thoracic esophageal squamous cell carcinoma previously untreated stage I-III
- Chest and abdominal contrast enhanced CT within 2 weeks prior to registration(PET/CT scan is selective)
- WBC ≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
- Platelets ≥ 100X109/L
- Hemoglobin ≥ 90g/L(without blood transfusion)
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
- Creatinine ≤ 1.5 x upper limit of normal
- Sign study-specific informed consent prior to study entry -
Exclusion Criteria:
- Multiple primary esophageal tumors
- 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).
-
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.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01551589
| 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 | |
| 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, Squamous Cell Esophageal Neoplasms Carcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Cisplatin Docetaxel Antimitotic Agents Antineoplastic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators |
ClinicalTrials.gov processed this record on February 27, 2015