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AzTrials

Esophageal CancerPhase 2NCT00069953

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

A Phase 2 study testing filgrastim, pegfilgrastim and cisplatin in people with Esophageal Cancer, run by Radiation Therapy Oncology Group at 97 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Esophageal Cancer
What is being tested?
filgrastim, pegfilgrastim and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
97 sitesUnited States
Study dates
Sep 2003to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

United States97 sites

  • Akron City Hospital

    Akron, Ohio, 44309-2090

  • Albuquerque Regional Medical Center at Lovelace Sandia Health System

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

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

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

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

    Aurora, Colorado, 80045

  • Ochsner Clinic of Baton Rouge

    Baton Rouge, Louisiana, 708169990

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Mount Sinai Hospital Medical Center

    Chicago, Illinois, 60608

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Wendt Regional Cancer Center at Finley Hospital

    Dubuque, Iowa, 52001

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Green Bay Oncology, Limited at St. Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

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

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

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

    Grosse Pointe Woods, Michigan, 48236

  • Hattiesburg Clinic, P.A.

    Hattiesburg, Mississippi, 39401

  • Saint Rose Hospital

    Hayward, California, 94545

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Green Bay Oncology, Limited - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Foote Hospital

    Jackson, Michigan, 49201

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fox Chase Virtua Health Cancer Program - Marlton

    Marlton, New Jersey, 08053

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Providence Holy Cross Cancer Center

    Mission Hills, California, 91346-9600

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Hospital of Saint Raphael

    New Haven, Connecticut, 06511

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Summit Medical Center

    Oakland, California, 94609

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Booker Cancer Center at Riverview Medical Center

    Red Bank, New Jersey, 07701

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

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

    Salem, Ohio, 44460

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

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

    San Pablo, California, 94806

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

    Savannah, Georgia, 31403-3089

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Community Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Schiffler Cancer Center at Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Wilmed Radiation Oncology Services

    Wilson, North Carolina, 27893

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus

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.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction.
  • Determine the overall and disease-free survival of patients treated with this regimen.
  • Determine the treatment-related toxicity of this regimen in these patients.
  • Determine the tolerance to surgical salvage in patients treated with this regimen.
  • Determine the morbidity and mortality of surgical salvage in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and 34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence of unacceptable toxicity.
  • Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96.

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

Patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer
Medical subject headings
Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • filgrastimBiological

    Also called G-CSF

    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.

  • pegfilgrastimBiological

    Also called PEG-G-CSF

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

  • cisplatinDrug

    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.

  • fluorouracilDrug

    Also called 5-FU

    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.

  • paclitaxelDrug

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

  • conventional surgeryProcedure or surgery

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

  • radiation therapyRadiation

    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.

Study groups in NCT00069953
Study groupRoleWhat they receive
ChemoRT and selective surgeryExperimentalInduction 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.
Receives: Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: fluorouracil; Drug: paclitaxel; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

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

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

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

    Measured: Analysis occurs with the primary outcome measure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionMar 2007
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069953
Sponsor's protocol ID
RTOG-0246
Other IDs
CDR0000306455
Status last verified
Dec 2016
First submitted
3 Oct 2003
Last updated
17 Feb 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21507583

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, pegfilgrastim and cisplatin in people with Esophageal Cancer, run by Radiation Therapy Oncology Group at 97 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (1-year Rate Reported) (time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00069953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.

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