Phase II Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma

NCT ID: NCT02384811

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-07-31

Brief Summary

The primary object of this trial is to evaluate the 2-year local control rate adding extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation group

Radiation therapy

Group Type: EXPERIMENTAL

radiation

Intervention Type: RADIATION

A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.

The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.

Interventions

radiation

A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.

The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Joined the study voluntarily and signed informed consent form;
• Age 18-75；ECOG 0-2
• Esophageal squamous cell carcinoma , radical surgery ≤3 months,R0 resection. The operative incision healed well.
• T3-4N0M0, T1-4N1-3M0 (according to AJCC2009)
• No radiotherapy, chemotherapy or other treatments pre(post)surgery
• PS ECOG 0-2
• Life expectancy of more than 3 months
• Hemoglobin(Hb)≥9 g/dL • WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L • platelet count (Pt) ≥100x 109/L • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL<1.5 x ULN • Renal function: creatinine < 1.5 x ULN
• No immuno-deficiency
• Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria

• Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis
• Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
• Participation in other interventional clinical trials within 30 days
• Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
• Drug addiction, Alcoholism or AIDS
• Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
• Unsuitable to be enrolled in the trial in the opinion of the investigators

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jiaqing Xiang

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jia-qing Xiang, M.M

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

Zhang X, Ai D, Wang J, Chen Y, Liu Q, Deng J, Yang H, Nie Y, Chen W, Zhao W, Zhao K. The Prognosis and Feasibility of Extensive Clinical Target Volume in Postoperative Radiotherapy for Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial. Front Oncol. 2021 Jul 2;11:669575. doi: 10.3389/fonc.2021.669575. eCollection 2021.

Reference Type: DERIVED

PMID: 34295813 (View on PubMed)

Other Identifiers

2014-86-882

Identifier Type: -

Identifier Source: org_study_id