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

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

Esophageal Neoplasms

Treatments

Drug: Platinum-Based Drug
Drug: Paclitaxel
Radiation: SIB-IMRT

Study type

Interventional

Funder types

Other

Identifiers

NCT03308552
3JECROG P-02

Details and patient eligibility

About

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.

Enrollment

164 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 < 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 2 patient groups, including a placebo group

SIB-IMRT combined chemotherapy followed by chemotherapy
Active Comparator group
Description:
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. Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.
Treatment:
Radiation: SIB-IMRT
Drug: Paclitaxel
Drug: Platinum-Based Drug
SIB-IMRT Alone followed by chemotherapy
Placebo Comparator group
Description:
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.
Treatment:
Radiation: SIB-IMRT
Drug: Paclitaxel
Drug: Platinum-Based Drug

Trial contacts and locations

0

Loading...

Central trial contact

Xiao Chang, MD; Xin Wang, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems