Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03
NCT ID: NCT03328234
Last Updated: 2019-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
2 participants
INTERVENTIONAL
2017-09-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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SIB-IMRT combined chemotherapy with IFI
SIB-IMRT
Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Paclitaxel
45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Paclitaxel
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Involved Field Irradiation (IFI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.
SIB-IMRT with IFI
SIB-IMRT
Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Paclitaxel
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Involved Field Irradiation (IFI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.
Interventions
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SIB-IMRT
Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Paclitaxel
45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Paclitaxel
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Platinum-Based Drug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Involved Field Irradiation (IFI)
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
* A untreated squamous esophageal carcinoma
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* Adequate organ function
* No known history of drug allergy
* Blood routine examination : WBC≥4.0
* hepatic and renal function are normal
Exclusion Criteria
* Already received the treatment of chemotherapy or radiotherapy
* Pregnant or lactating females
* Known drug allergy
* Without agreement of informed consent form
* Insufficient hepatorenal function or Blood routine examination
* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
18 Years
69 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Zefen Xiao
Pricipal investigator
Locations
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Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3JECROG P-03
Identifier Type: -
Identifier Source: org_study_id
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