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

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 Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03328234

Enrollment

Registered

2017-11-01

Start date

2017-09-01

Completion date

2022-12-31

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

IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer

Brief summary

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.

Interventions

RADIATIONSIB-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.

DRUGPaclitaxel

45-50mg/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

OTHERInvolved 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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 ≤ 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.

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	1 year

Secondary

Measure	Time frame
Progression-free survival (PFS)	1 year
Local recurrence-free rate（LRFS）	1 year
Completion Rate	up to 2 year
Adverse events	up to 5 year

Countries

China

Contacts

Primary ContactXin Wang, MD

beryl_wx2000@163.com+86-13311583220

Outcome results

None listed

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