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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03535207
Other study ID # SGH201802
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date June 30, 2022

Study information

Verified date March 2021
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact Ningning Cheng
Phone 37798364
Email ningcnn@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced esophageal cancer


Description:

The Radiation Therapy Oncology Group (RTOG) 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional failure remains problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the standard dose (50-50.4 Gy) chemoradiotherapy . Our previous phase I radiation dose escalation trial established the maximum tolerated dose of 86 Gy with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Histologically confirmed primary squamous cell carcinoma of the esophagus - Age 1 8-75. - Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 - No prior radiation to the thorax that would overlap with the current treatment field. - Patients with nodal involvement are eligible - Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) =2 × 10^9 cells/L,bilirubin and Aspartate transaminase =1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN. - A signed informed consent must be obtained prior to therapy. - Induction chemotherapy is allowed Exclusion Criteria: - The presence of a fistula. - Prior radiotherapy that would overlap the radiation fields. - gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall. - Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. - Known hypersensitivity to paclitaxel. - Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study. - Acquired Immune Deficiency Syndrome. - Conditions precluding medical follow-up and protocol compliance

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
high dose chemoradiotherapy
Radiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy after high dose chemoradiation is optional.

Locations

Country Name City State
China Shanghai Genernal Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective rand — View Citation

Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival rate survival time was measured from the date of study enrollment to the date of death or last follow-up one year
Secondary toxicities Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4. 1 year
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