Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Neoplasms |
Radiation: SMART Drug: concurrent and adjuvant chemotherapy (cisplatin, 5fluorouracil) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma |
- Toxicities [ Time Frame: The period during treatment and the 2 years after treatment ] [ Designated as safety issue: Yes ]The acute toxicities and 2-year late toxicities of esophagus and lungs.
- local control rate [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
- overall survival rate [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SMART
SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)
|
Radiation: SMART
The PTV 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: concurrent and adjuvant chemotherapy (cisplatin, 5fluorouracil)
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: PF
|
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 50.4~60Gy 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 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 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 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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 expectency > 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
Contacts and Locations| Contact: Jianzhou Chen, MD | 86-13417049908 | cjz8080@163.com |
| Contact: Chuangzhen Chen, MD | 86-13923995569 | stccz@139.com |
| China, Guangdong | |
| Cancer Hospital, Shantou University Medical College | Recruiting |
| Shantou, Guangdong, China, 515031 | |
| Contact: Chuangzhen Chen, MD 86-13923995569 stccz@139.com | |
| Contact: Jianzhou Chen, MD 86-13417049908 cjz8080@163.com | |
| Principal Investigator: Chuangzhen Chen, MD | |
| Principal Investigator: | Chuangzhen Chen, MD | Cancer Hospital, Shantou University Medical College |
More Information
No publications provided
| Responsible Party: | Chuangzhen Chen, M.D., Shantou University Medical College |
| ClinicalTrials.gov Identifier: | NCT01670409 History of Changes |
| Other Study ID Numbers: | SUMC-ECA-001, ChiCTR-ONC-12002356 |
| Study First Received: | August 12, 2012 |
| Last Updated: | August 19, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Shantou University Medical College:
|
Esophageal squmous cell carcinoma SMART IMRT Chemotherapy |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Adjuvants, Immunologic Cisplatin Fluorouracil Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 21, 2013