AzTrials
AzTrials

Esophageal CancerPhase 2NCT00009880

Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach

A Phase 2 study testing filgrastim, cisplatin and fluorouracil in people with Esophageal Cancer and Gastric Cancer, run by Radiation Therapy Oncology Group at 66 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 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
filgrastim, cisplatin and fluorouracil
Type of treatment
Surgery or procedure
How many people
Not given
Where
66 sitesUnited States
Study dates
Apr 2001to Jul 2006
Phase
Phase 2
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)
  • Supraclavicular or celiac lymph node involvement allowed
  • 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
  • Bronchoscopy with biopsy and cytology required if the primary carcinoma is less than 26 cm from the incisors or is at or above the carina by imaging study

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil 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
  • Creatinine clearance at least 65 mL/min

Cardiovascular:

  • No uncontrolled heart disease
  • No uncontrolled hypertension

Other:

  • Total oral/enteral intake must be at least 1,700 kCal/day
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled diabetes
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior chest radiotherapy

Surgery:

  • No prior major esophageal surgery

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Akron General's McDowell Cancer Center

    Akron, Ohio, 44302

  • Akron City Hospital at Summa Health System

    Akron, Ohio, 44304

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106-5065

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Mount Carmel West Hospital

    Columbus, Ohio, 43222

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Delaware County Regional Cancer Center at Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center at Finley Hospital

    Dubuque, Iowa, 52001

  • Dale and Frances Hughes Cancer Center at Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    East Syracuse, New York, 13057

  • Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center

    Edgewood, Kentucky, 41017

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0385

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27533

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750-1635

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • Baptist-South Miami Regional Cancer Program

    Miami, Florida, 33176-2197

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112-2699

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055-2899

  • Leavey Cancer Center at Northridge Hospital Medical Center

    Northridge, California, 91328

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

    Omaha, Nebraska, 68114-4199

  • Cancer Center at Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Atlantic City Medical Center - Mainland Division

    Pomona, New Jersey, 08240

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • All Saints Cancer Center at All Saints Healthcare

    Racine, Wisconsin, 53405

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Union Hospital

    Terre Haute, Indiana, 47804

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: Non-Operative Therapy Of Local-Regional Carcinoma Of The Esophagus: A Randomizd Phase II Study Of Two Paclitaxel-Based Chemoradiotherapy Regimens

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.

Read the detailed description

OBJECTIVES:

  • Compare the survival and failure patterns in patients with previously untreated carcinoma of the esophagus or gastroesophageal junction treated with cisplatin, paclitaxel, and concurrent radiotherapy with or without fluorouracil.
  • Compare the tolerance of these regimens by these patients.
  • Compare the overall quality of life of patients treated with these regimens.

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.

  • Arm I: Patients receive induction chemotherapy comprising fluorouracil IV continuously over 24 hours and cisplatin IV over 1 hour on days 1-5, paclitaxel IV continuously over 24 hours on day 1, and filgrastim (G-CSF) subcutaneously daily on days 6-15. Treatment repeats every 4 weeks for up to 2 courses. Patients with stable or responsive disease after the first course of induction therapy receive a second course of therapy. Patients with local disease progression after the first course proceed to chemoradiotherapy.

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.

  • Arm II: Patients receive induction chemotherapy comprising cisplatin IV and paclitaxel IV over 3 hours on day 1. Treatment continues every 3 weeks for 2 courses as in arm I.

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.

Being tested
filgrastim, cisplatin, fluorouracil, paclitaxel, radiation therapy
Keywords
stage I gastric cancer, stage II gastric cancer, stage III gastric cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the stomach, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus

What participants receive

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

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001
  3. Primary completionJul 2006

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00009880
Sponsor's protocol ID
RTOG-0113
Other IDs
CDR0000068420
Status last verified
Jul 2004
First submitted
2 Feb 2001
Last updated
19 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18574157

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, cisplatin and fluorouracil in people with Esophageal Cancer and Gastric Cancer, run by Radiation Therapy Oncology Group at 66 sites in United States.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00009880, which also lists 3 linked publications.

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 19 Jul 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in