Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

NCT00069953 | Completed Phase 2 Results DMC

• 2 other identifiers: RTOG-0246CDR0000306455
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 97

Brief Summary

RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin 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 with radiation therapy may kill more tumor cells PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage II esophageal cancer; stage III esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (1-year Rate Reported)

  One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).

  From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.

Secondary Outcomes (2)

• Frequency of Major (Grade 4) Acute Treatment-related Toxicities

  From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).

• Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection

  Analysis occurs with the primary outcome measure.

Study Arms (1)

ChemoRT and selective surgery

EXPERIMENTAL

Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.

Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: fluorouracil; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients \>70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42.

Also known as: G-CSF

ChemoRT and selective surgery

pegfilgrastim BIOLOGICAL

During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34.

Also known as: PEG-G-CSF

ChemoRT and selective surgery

cisplatin DRUG

During induction therapy, patients receive 15 mg/m\^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m\^2/day by IV over 1 hour beginning on days 57-61.

ChemoRT and selective surgery

fluorouracil DRUG

During induction therapy, patients receive 650 mg/m\^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m\^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles.

Also known as: 5-FU

ChemoRT and selective surgery

paclitaxel DRUG

During induction therapy, patients receive 200 mg/m\^2/day by IV over 2 hours on days 1 and 29.

ChemoRT and selective surgery

conventional surgery PROCEDURE

Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.

ChemoRT and selective surgery

radiation therapy RADIATION

External beam radiotherapy with megavoltage linear accelerators (\> 6 MV) will be used to deliver multiple (\> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy.

ChemoRT and selective surgery

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction * Primary (non-recurrent) disease * Amenable to resection * Stage greater than T1, N0 by endoscopic ultrasound * Must be entirely confined to the esophagus or gastroesophageal junction and periesophageal soft tissue * Tumor may not extend more than 2 cm into the stomach * No multiple primary carcinomas of the esophagus * No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus * No evidence of disseminated cancer * Suggestion of liver metastases by positron emission tomography must be proven negative by biopsy or other imaging studies * Palpable supraclavicular nodes must be negative for cancer by biopsy * Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion * No celiac adenopathy greater than 2 cm PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Not specified Renal * Creatinine no greater than 1.5 mg/dL AND/OR * Creatinine clearance at least 65 mL/min * Calcium no greater than 11 mg/dL Cardiovascular * No uncontrolled heart disease * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to comprehend study requirements and considered likely to comply with study parameters * No other malignancy within the past 5 years except curable nonmelanoma skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes * No hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 5 years since prior systemic chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior chest or upper abdomen radiotherapy Surgery * No prior esophageal or gastric surgery Other * No concurrent photodynamic therapy * No other concurrent investigational agents for esophageal carcinoma

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (97)

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Providence Holy Cross Cancer Center

Mission Hills, California, 91346-9600, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Summit Medical Center

Oakland, California, 94609, United States

Location

Valley Care Medical Center

Pleasanton, California, 94588, United States

Location

J.C. Robinson, M.D. Regional Cancer Center

San Pablo, California, 94806, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Hospital of Saint Raphael

New Haven, Connecticut, 06511, United States

Location

Baptist-South Miami Regional Cancer Program

Miami, Florida, 33176, United States

Location

Gulf Coast Cancer Treatment Center

Panama City, Florida, 32405, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Mount Sinai Hospital Medical Center

Chicago, Illinois, 60608, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Wendt Regional Cancer Center at Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Ochsner Clinic of Baton Rouge

Baton Rouge, Louisiana, 708169990, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, 49431, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Green Bay Oncology, Limited - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

Foote Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48909, United States

Location

Seton Cancer Institute - Saginaw

Saginaw, Michigan, 48601, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422-2900, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Health Services

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Hattiesburg Clinic, P.A.

Hattiesburg, Mississippi, 39401, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Fox Chase Virtua Health Cancer Program - Marlton

Marlton, New Jersey, 08053, United States

Location

Booker Cancer Center at Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Community Regional Cancer Center at Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Albuquerque Regional Medical Center at Lovelace Sandia Health System

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilmed Radiation Oncology Services

Wilson, North Carolina, 27893, United States

Location

Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Salem, Ohio, 44460, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Schiffler Cancer Center at Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Related Publications (1)

• Swisher SG, Winter KA, Komaki RU, Ajani JA, Wu TT, Hofstetter WL, Konski AA, Willett CG. A Phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1967-72. doi: 10.1016/j.ijrobp.2011.01.043. Epub 2011 Apr 18.

  PMID: 21507583 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; pegfilgrastim; pegylated granulocyte colony-stimulating factor, human; Cisplatin; Fluorouracil; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Stephen G. Swisher, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2003
• First Posted: October 7, 2003
• Study Start: September 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: December 1, 2016
• Last Updated: February 17, 2017
• Results First Posted: October 20, 2014

Record last verified: 2016-12

Locations

US (97)