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

A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03308552

Enrollment

164

Registered

2017-10-12

Start date

2017-12-01

Completion date

2021-08-30

Last updated

2019-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Neoplasms

Brief 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.

Interventions

RADIATIONSIB-IMRT

PTV:50.4Gy/28f, PGTV:59.92Gy/28f

DRUGPaclitaxel

45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks

DRUGPlatinum-Based Drug

Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

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 \< 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, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Design outcomes

Primary

Measure	Time frame
Overall survival（OS）	1 year

Secondary

Measure	Time frame	Description
Progress free survival（PFS）	1 year	—
Local recurrence-free rate（LRFS）	1 year	—
Completion Rate	up to 2 year	the completion rate of each arm
Adverse events	up to 5 year	—

Countries

China

Contacts

Primary ContactXin Wang, MD

beryl_wx2000@163.com+86-13311583220

Backup ContactXiao Chang, MD

changxiaojlu@163.com+86-18801067622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026