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

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.

Study Overview

• Status: Unknown
• Conditions: IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer
• Intervention / Treatment: Drug: Platinum-Based Drug; Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Paclitaxel; Drug: Platinum-Based Drug; Other: Involved Field Irradiation (IFI)

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xin Wang, MD; Phone Number: +86-13311583220; Email: beryl_wx2000@163.com

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIB-IMRT combined chemotherapy with IFI	Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Radiation: 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.; Drug: Paclitaxel; 45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Drug: Paclitaxel; 135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy; Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy; Other: Involved 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.
Experimental: SIB-IMRT with IFI	Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Radiation: 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.; Drug: Paclitaxel; 45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Drug: Paclitaxel; 135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy; Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy; Other: Involved 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	1 year
Overall survival (OS)	3 year
Overall survival (OS)	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS)	1 year
Local recurrence-free rate（LRFS）	1 year
Local recurrence-free rate（LRFS）	2 year
Local recurrence-free rate（LRFS）	3 year
Adverse events	up to 5 year
Progression-free survival (PFS)	2 year
Progression-free survival (PFS)	3 year
Completion Rate	up to 2 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 28, 2017
• First Submitted That Met QC Criteria: October 28, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 29, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Neoplastic Processes; Esophageal Diseases; Neoplasm Metastasis; Lymphatic Metastasis; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: 3JECROG P-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No