Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01670409 |
Other study ID # |
SUMC-ECA-001 |
Secondary ID |
ChiCTR-ONC-12002 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
August 2012 |
Est. completion date |
August 2015 |
Study information
Verified date |
December 2021 |
Source |
Shantou University Medical College |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year
local control and overall survival rates in patients with esophageal squamous cell carcinoma
receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.
Description:
Esophageal cancer is one of the most common malignant diseases in China, especially in
Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method
for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per
fraction generally. However, although with such comprehensive method, noncontrol of local
disease or recurrence is still the main reason of failure.
Most patients with esophageal cancer suffer from malnutrition. A number of factors including
hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local
failures of disease after treatment; therefore a higher radiation biological equivalent dose
(BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial
had shown that simply increasing total radiation dose could not gain better local control or
overall survival rate, however, the ability of this trial to test the potential benefits of
higher radiation dose could be compromized by the deficiencies within them, such as,
observation bias,large radiated target volume and usage of conventional radiation technique.
In other words, the probability that increasing radiation may help improving the control of
disease should not be denied.
Modern radiation techniques, such as intensity modulation radiation therapy (IMRT),
specially, are able to improve the coverage of target volumes and sparing of critical
structures, while increase the total radiation dose. By using simultaneous modulated
accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per
fraction could be reduced significantly, while the doses to tumor could be increased to
higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total
radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and
superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with
conventional technique.
Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and
overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late
toxicities would be tolerable and slighter than that of conventional technique.