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| ID | Type | Description | Link |
|---|---|---|---|
| BT-IST-SCCHN-037 | Other Identifier | BT-IST-SCCHN-037 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Involved Field Irradiation(IFI) | Experimental | 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. |
|
| Elective Nodal Irradiation (ENI) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Involved Field Irradiation(IFI) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| radiation pneumonitis and radiation esophagitis | radiation pneumonitis and radiation esophagitis, | Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Overall survival(OS) | 3-year Overall survival(OS) | CT scans performed every 6 months for 3 years |
| 3-year Disease-free survival | 3-year Disease-free survival |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| JINYI LANG, M.D. | The Second People's Hospital of Sichuan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Tumor Hospital | Nanning | Guangxi | 530021 | China | ||
| GuiZhou Cancer Hospital |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| docetaxel and cisplatin | Drug | 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. |
|
|
| Elective Nodal Irradiation (ENI) | Radiation | 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. |
|
| CT scans every 6 months for 3 years |
| Quality of life(QoL) | Quality of life(QoL) | Evaluation of quality of life every week for 3 months |
| Local control rate/ Inside irrational field recurrence rate | 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. | 2 year |
| Guiyang |
| Guizhou |
| 550000 |
| China |
| The Second People's Hospital of Sichuan | Chengdu | Sichuan | 610000 | China |
| Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University | Kunming | Yunnan | 652100 | China |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |