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Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT01670409
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):
Chuangzhen Chen, Shantou University Medical College

August 12, 2012
August 22, 2012
August 28, 2015
August 2012
August 2015   (Final data collection date for primary outcome measure)
Toxicities [ Time Frame: The period during treatment and the 2 years after treatment ]
The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.
Toxicities [ Time Frame: The period during treatment and the 2 years after treatment ]
The acute toxicities and 2-year late toxicities of esophagus and lungs.
Complete list of historical versions of study NCT01670409 on ClinicalTrials.gov Archive Site
  • local control rate [ Time Frame: 2 years after treatment ]
  • overall survival rate [ Time Frame: 2 years after treatment ]
Same as current
Not Provided
Not Provided
 
Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer
A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Esophageal Neoplasms
  • Radiation: SMART
    The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.
  • Drug: PF
    Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.
    Other Name: cisplatin plus 5fluorouracil
Experimental: SMART combined with PF chemotherpay
SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)
Interventions:
  • Radiation: SMART
  • Drug: PF
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
160
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01670409
SUMC-ECA-001
ChiCTR-ONC-12002356 ( Registry Identifier: Chinese Clinical Trial Registry )
No
Not Provided
Not Provided
Chuangzhen Chen, Shantou University Medical College
Chuangzhen Chen
Not Provided
Principal Investigator: Chuangzhen Chen, MD Cancer Hospital, Shantou University Medical College
Shantou University Medical College
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP