Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown
Phase 3

Conditions

IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Treatments

Radiation: SIB-IMRT
Other: Involved Field Irradiation (IFI)
Drug: Paclitaxel
Drug: Platinum-Based Drug

Study type

Interventional

Funder types

Other

Identifiers

NCT03328234
3JECROG P-03

Details and patient eligibility

About

The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.

Enrollment

2 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age<70
  • 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

  • Age≥ 70 or ≤ 16
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

2 participants in 2 patient groups

SIB-IMRT combined chemotherapy with IFI
Experimental group
Treatment:
Drug: Platinum-Based Drug
Drug: Paclitaxel
Other: Involved Field Irradiation (IFI)
Radiation: SIB-IMRT
SIB-IMRT with IFI
Experimental group
Treatment:
Drug: Platinum-Based Drug
Drug: Paclitaxel
Other: Involved Field Irradiation (IFI)
Radiation: SIB-IMRT

Trial contacts and locations

0

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Central trial contact

Xin Wang, MD

Data sourced from clinicaltrials.gov

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