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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068420 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to percentage of weight loss (less than 10% vs 10% or more), disease histology (adenocarcinoma vs squamous cell carcinoma), and lesion size (no more than 5 cm vs more than 5 cm). Patients are randomized to one of two treatment arms.
Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy 5 days a week for 5.5 weeks. Patients also receive fluorouracil IV continuously over 24 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33, and paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.
Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36, and paclitaxel IV continuously over 96 hours on days 1-4, 8-11, 15-18, 22-25, 29-32, and 36-39.
Quality of life is assessed at baseline, within 1 week after radiotherapy, at 6 weeks after study completion, every 4 months for 1 year, every 6 months for 2 years, and then annually for 5 years.
Patients are followed within 8 weeks, every 4 months for 1 year, every 6 months for two years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study within 21 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| cisplatin | Drug | |||
| fluorouracil | Drug | |||
| paclitaxel | Drug | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
Stage I-III (T1, N1, M0; T2-4, N any, M0)
Disease entirely confined to the esophagus or gastroesophageal junction and peri-esophageal soft tissue
Cervical esophageal carcinoma allowed
No tumor extension beyond 2 cm into stomach
No multiple primary carcinomas of the esophagus
No evidence of disseminated cancer
No tracheoesophageal fistula or direct invasion into the mucosa of the trachea or major bronchi
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Jaffer A. Ajani, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Foundation for Cancer Research and Education |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18574157 | Result | Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113. J Clin Oncol. 2008 Oct 1;26(28):4551-6. doi: 10.1200/JCO.2008.16.6918. Epub 2008 Jun 23. | |
| Result | Komaki R, Winter K, Ajani J: Non-operative therapy of local-regional carcinoma of the esophagus: a randomized phase II study of two paclitaxel-based chemoradiotherapy regimens (RTOG 0113). [Abstract] The American Radium Society 89th Annual Meeting, May 5-29, 2007, Amsterdam, Netherlands. A-SS-2, 1, 2007. | ||
| Result | Komaki R, Winter K, Ajani A, et al.: A randomized phase II study of two paclitaxel-based chemoradiotherapy regimens for patients with the non-operative esophageal carcinoma (RTOG 0113). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-142, S79-80, 2006. |
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| Phoenix |
| Arizona |
| 85013 |
| United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
| Leavey Cancer Center at Northridge Hospital Medical Center | Northridge | California | 91328 | United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0385 | United States |
| Baptist-South Miami Regional Cancer Program | Miami | Florida | 33176-2197 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis | Indiana | 46202 | United States |
| Cancer Center at Ball Memorial Hospital | Muncie | Indiana | 47303-3499 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Union Hospital | Terre Haute | Indiana | 47804 | United States |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center | Edgewood | Kentucky | 41017 | United States |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112-2699 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha | Omaha | Nebraska | 68114-4199 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Atlantic City Medical Center - Mainland Division | Pomona | New Jersey | 08240 | United States |
| Community Medical Center | Toms River | New Jersey | 08755 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | East Syracuse | New York | 13057 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27533 | United States |
| Akron General's McDowell Cancer Center | Akron | Ohio | 44302 | United States |
| Akron City Hospital at Summa Health System | Akron | Ohio | 44304 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland | Ohio | 44106-5065 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| Mount Carmel West Hospital | Columbus | Ohio | 43222 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750-1635 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055-2899 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| St. Luke's Hospital Cancer Center | Bethlehem | Pennsylvania | 18015 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg | Pennsylvania | 18301 | United States |
| Cancer Center at Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-4772 | United States |
| Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Community Memorial Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin | 53405 | United States |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | 53188 | United States |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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