High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Phase II Study of High-dose （86 Gy）Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535207
• Other study ID #: SGH201802
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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