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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Neoplasms
• Intervention / Treatment: Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug; Drug: Paclitaxel; Drug: Platinum-Based Drug

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xin Wang, MD; Phone Number: +86-13311583220; Email: beryl_wx2000@163.com
• Study Contact Backup: Name: Xiao Chang, MD; Phone Number: +86-18801067622; Email: changxiaojlu@163.com

Study Locations

• China
  • Beijing
    • Beijing, 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)
      • Contact: Zefen Xiao, MD

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 < 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SIB-IMRT combined chemotherapy followed by chemotherapy; 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.	Radiation: SIB-IMRT; PTV:50.4Gy/28f, PGTV:59.92Gy/28f; Drug: Paclitaxel; 45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Drug: Paclitaxel; 150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy; Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy
Placebo Comparator: SIB-IMRT Alone followed by chemotherapy; 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.	Radiation: SIB-IMRT; PTV:50.4Gy/28f, PGTV:59.92Gy/28f; Drug: Paclitaxel; 45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks; Drug: Paclitaxel; 150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy; Drug: Platinum-Based Drug; Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress free survival（PFS）		1 year
Progress free survival（PFS）		2 year
Progress free survival（PFS）		3 year
Local recurrence-free rate（LRFS）		1 year
Local recurrence-free rate（LRFS）		2 year
Local recurrence-free rate（LRFS）		3 year
Completion Rate	the completion rate of each arm	up to 2 year
Adverse events		up to 5 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Fujian Cancer Hospital; Tianjin Medical University Cancer Institute and Hospital; Affiliated Hospital of Hebei University; Hebei Medical University Fourth Hospital; Anyang Tumor Hospital; Sichuan Cancer Hospital and Research Institute
• Investigators: Principal Investigator: Zefen Xiao, MD, The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science

Publications and helpful links

General Publications

• Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): August 30, 2020
• Study Completion (Anticipated): August 30, 2021

Study Registration Dates

• First Submitted: October 8, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 12, 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-02

Drug and device information, study documents

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