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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02570893
• Other study ID #: ZTOG-1401
• Status: Recruiting
• Phase: Phase 3
• First received: October 3, 2015
• Last updated: October 6, 2015
• Start date: May 2015
• Est. completion date: October 2020

Study information

• Verified date: October 2015
• Source: Zhejiang Cancer Hospital
• Contact: Weimin Mao, MD.
• Phone: +86-571-88122032
• Email: maowmzj1218[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: October 2020
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Drug:
• Paclitaxel and carboplatin

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall survival	To evaluate the 3 years overall survival of two groups.	3 years	No
Secondary	Disease-free survival	To evaluate the 3 years disease-free survival of two groups.	3 years	No
Secondary	Adverse Events	Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0	1 year	No
Secondary	Scores of Quality of life	Assess the quality of life based on FACT-E	1 year	No