Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy for Locally Advanced Esophageal Carcinoma

Esophageal Neoplasms Clinical Trial

Official title:

A Phase Ⅰ/Ⅱ Study of Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy in Patients With Locally Advanced Esophageal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429622
• Other study ID #: 14-133/923
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 24, 2015
• Last updated: January 16, 2017
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for locally advanced esophageal carcinoma.

Description:

Despite the application of IMRT and the studies of concurrent chemoradiation in esophageal carcinoma, which improves 5-year survival rate from 10% to 20%-40% and decrease recurrence rate from 80% to 50%-60%, local recurrence remains to be the most common failure pattern. Therefore, enhancing local control is the key to obtain a better survival.

A phase Ⅱ study of radical radiotherapy with IMRT simultaneous integrated boost technique and concurrent chemotherapy for esophageal carcinoma use the same radiation dose as the high dose arm in RTOG 94-05, which reveals an significantly improved median survival time of 23 months and 3-year overall survival rate of 44.4%. This study implies the simultaneous integrated boost technique may be effective to some extent. But the question is how to identify patients who may gain potential benefits, and whether this therapeutic model can be copied in the specific situation in China? Few adverse effects such as perforation, hemorrhage and stenosis was reported, mainly owing to the lack of cases. For widely application of this new technique in the clinic, more studies need to be conducted in the future to obtain sufficient evidence.

The current IMRT can simultaneously achieve prophylactic dose (DT 50Gy) and radical dose (DT 60-64Gy) in respective target volume by using inverse intensity-modulated planning system. However, it is still controversial on whether esophageal carcinoma can receive prescription dose more than 2.0Gy each time. That is to say, it is challengeable to find an optimal fraction dose and total dose between tumor and adverse effects. For this reason, the dose escalation trial is to be conducted to explore the clinical value and optimal dose to esophageal carcinoma with different radiosensitivity, and also provide data support for phase Ⅲ clinical trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

Inclusion Criteria:

• Diagnosis of clinical stage T2-4N0-1M1a untreated squamous esophageal carcinoma

• KPS=70

• Adequate organ function

• No known history of drug allergy

Exclusion Criteria:

• Known drug allergy

• Insufficient hepatorenal function

• Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Radiation:
• IMRT simultaneous integrated boost
To achieve a prophylactic dosage and radical dosage once respectively

Drug:
• Paclitaxel
Paclitaxel from 45 to 60 mg/m2 per week concurrent with radiotherapy for 5weeks
• Nedaplatin
Nedaplatin 25mg/m2 per week concurrent with radiotherapy for 5weeks

Procedure:
• Esophagectomy
Radical esophagectomy 4-6 weeks after neoadjuvant therapy

Locations

Country	Name	City	State
China	Zefen Xiao	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose — View Citation

Welsh J, Settle SH, Amini A, Xiao L, Suzuki A, Hayashi Y, Hofstetter W, Komaki R, Liao Z, Ajani JA. Failure patterns in patients with esophageal cancer treated with definitive chemoradiation. Cancer. 2012 May 15;118(10):2632-40. doi: 10.1002/cncr.26586. — View Citation

Yu WW, Zhu ZF, Fu XL, Zhao KL, Mao JF, Wu KL, Yang HJ, Fan M, Zhao S, Welsh J. Simultaneous integrated boost intensity-modulated radiotherapy in esophageal carcinoma: early results of a phase II study. Strahlenther Onkol. 2014 Oct;190(11):979-86. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		up to 5 years
Primary	Disease-free survival (DFS)		up to 3 years
Secondary	Overall survival (OS)		up to 5 years