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

Fudan University logo

Fudan University

Status and phase

Unknown
Phase 2

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Radiation: radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02384811
2014-86-882

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Radiation group
Experimental group
Description:
Radiation therapy
Treatment:
Radiation: radiation

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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