Clinical trial NCT01670409: Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer
Official title: A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Neoplasms
Keywords: Esophageal squamous cell carcinoma
SMART
IMRT
Chemotherapy
Lead sponsor: Shantou University Medical College
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* pathological proven diagnosis of primary squamous cell carcinoma of the esophagus
* the primary disease located in cervical, upper or middle thoracic esophagus
* no distant metastases
* zubrod performance status: 0\~2
* life expectancy \> 6 months; -absence of another malignancy
* adequate liver, renal and bone marrow function
* women of childbearing potential and male participants must practice adequate contraception
* patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

* evidence of tracheoesophageal or Mediastinal-esophageal fistula
* prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
* prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity
* pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* women who are nursing

Primary outcomes:
measure: Toxicities
timeFrame: The period during treatment and the 2 years after treatment
Secondary outcomes:
measure: Local control rate
timeFrame: 2 years after treatment
measure: overall survival rate
timeFrame: 2 years after treatment
measure: Complete blood count
timeFrame: before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)
Other outcomes:
Locations:
city: Shantou
country: China
facility: Cancer Hospital, Shantou University Medical College
state: Guangdong
Study officials:
affiliation: Cancer Hospital, Shantou University Medical College
name: Chuangzhen Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang WZ, Chen JZ, Li DR, Chen ZJ, Guo H, Zhuang TT, Li DS, Zhou MZ, Chen CZ. Simultaneous modulated accelerated radiation therapy for esophageal cancer: a feasibility study. World J Gastroenterol. 2014 Oct 14;20(38):13973-80. doi: 10.3748/wjg.v20.i38.13973.