A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma

A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma

This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Paclitaxel and carboplatin; Radiation: Adjuvant radiotherapy; Radiation: Adjuvant radiotherapy

Detailed Description

Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only

• Study Type: Interventional
• Enrollment (Anticipated): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Weimin Mao, MD.; Phone Number: +86-571-88122032; Email: maowmzj1218@163.com
      • Contact: Yaping Xu, MD.; Phone Number: +86-571-88122082; Email: xuyaping1207@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;
2. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
3. The expectation of life is more than 6 months;
4. Age: 18~70 years old;
5. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
6. ECOG (Eastern Cooperative Oncology Group) : 0-1;
7. Able to understand this study and have signed informed consent.

Exclusion Criteria:

1. Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;
2. Known or suspected of allergy to paclitaxel or carboplatin;
3. Female in pregnancy or lactating;
4. With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
5. Patients with peripheral neuropathy(CTC grade≥2);
6. With other malignant tumors before the recruitment.
7. The researchers consider that the patient is not appropriate to enroll the study;
8. The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.

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
Experimental: adjuvant chemoradiotherapy; Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.	Drug: Paclitaxel and carboplatin; Radiation: Adjuvant radiotherapy; Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.; Radiation: Adjuvant radiotherapy; adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
Experimental: adjuvant radiotherapy; Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.	Radiation: Adjuvant radiotherapy; Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.; Radiation: Adjuvant radiotherapy; adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall survival	To evaluate the 3 years overall survival of two groups.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	To evaluate the 3 years disease-free survival of two groups.	3 years
Adverse Events	Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0	1 year
Scores of Quality of life	Assess the quality of life based on FACT-E	1 year

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Weimin Mao, MD., Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: October 3, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: ZTOG-1401