Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02

Last updated: December 29, 2018
Sponsor: Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

Esophageal Disorders

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT03308552
3JECROG P-02
  • Ages 18-69
  • All Genders

Study Summary

This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Age≥ 70 or < 18

  • 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, mentaldisorders, uncontrolled severe infection, active ulceration which need intervention.

Study Design

Total Participants: 164
Study Start date:
December 01, 2017
Estimated Completion Date:
August 30, 2021

Connect with a study center

  • Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

    Beijing, Beijing 100021
    China

    Active - Recruiting

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