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To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced esophageal cancer
The Radiation Therapy Oncology Group (RTOG) 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional failure remains problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the standard dose (50-50.4 Gy) chemoradiotherapy . Our previous phase I radiation dose escalation trial established the maximum tolerated dose of 86 Gy with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose chemoradiotherapy | Experimental | all eligible patients receive intensity-modulated radiotherapy 50 Gy in 25 fractions over 5 weeks and concurrent paclitaxel and cisplatin once weekly for 5 weeks,followed by hyperfractionated intensity-modulated radiotherapy boost to gross tumor volume concurrent with the same chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high dose chemoradiotherapy | Radiation | Radiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy after high dose chemoradiation is optional. |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival rate | survival time was measured from the date of study enrollment to the date of death or last follow-up | one year |
| Measure | Description | Time Frame |
|---|---|---|
| toxicities | Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4. | 1 year |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ningning Cheng | Contact | 37798364 | 8119 | ningcnn@163.com |
| Yong Liu, MD | Contact | 37798364 | 8119 | drliuyrt@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tingfeng Chen, MD | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Genernal Hospital | Recruiting | Shanghai | Shanghai Municipality | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1584260 | Background | Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403. | |
| 10235156 | Result |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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|
| 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 randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |