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Esophageal CancerPhase 2NCT00011960

Chemotherapy and Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Stomach Who Have Undergone Surgery

A Phase 2 study testing cisplatin, paclitaxel and adjuvant therapy in people with Esophageal Cancer and Gastric Cancer, run by Radiation Therapy Oncology Group at 69 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 cisplatin and paclitaxel 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?
Any age
Conditions the study is for
Esophageal Cancer, Gastric Cancer
What is being tested?
cisplatin, paclitaxel and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
69 sitesUnited States
Study dates
May 2001to May 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 stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor
  • No more than 8 weeks since primary tumor resection
  • No metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC (white blood cell count) at least 4,000/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than 2.5 times upper limit of normal

Renal:

  • BUN(blood urea nitrogen)less than 30 mg/dL
  • Creatinine no greater than 1.4 mg/dL
  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No active angina or myocardial infarction within the past 6 months
  • No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
  • No history of clinically significant conduction system abnormality

Other:

  • No concurrent serious infection that is uncontrolled or would preclude study participation
  • No nonmalignant medical illness that is uncontrolled or would preclude study participation
  • No psychiatric disorders that would preclude study participation
  • No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No clinically significant hearing loss
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to the treatment field

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent anticancer therapy

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

United States69 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital - Summa Health System

    Akron, Ohio, 44304

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • CCOP - Dayton

    Dayton, Ohio, 45429

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

    Denver, Colorado, 80010

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • Pocono Cancer Center

    East Stroudsburg, Pennsylvania, 18301

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Alexian Brothers Cancer Care Center

    Elk Grove Village, Illinois, 60007

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Wayne Memorial Hospital, Inc.

    Goldsboro, North Carolina, 27533

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Cancer Center at Lexington Clinic

    Lexington, Kentucky, 40504

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Baptist Hospital of Miami

    Miami, Florida, 33256-2110

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Mount Holly, New Jersey, 08060

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8040

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

    Omaha, Nebraska, 68114-4199

  • St. Charles Hospital

    Oregon, Ohio, 43616

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139-0000

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Flower Hospital - ProMedica Health System

    Sylvania, Ohio, 43560

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

    Syracuse, New York, 13217

  • Medical College of Ohio Cancer Institute

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: A Randomized Phase II Comparison Of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens In Resected Gastric Cancers

RATIONALE: Drugs used in chemotherapy such as cisplatin and paclitaxel 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. Cisplatin and paclitaxel may make the tumor cells more sensitive to radiation therapy and may kill any tumor cells remaining after surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of cisplatin, paclitaxel, and radiation therapy with or without fluorouracil in treating patients who have stage IB, stage IIB, or stage IIIB stomach cancer that has been removed during surgery.

Read the detailed description

OBJECTIVES:

  • Compare the 2-year disease-free survival in patients with resected stage IB-IIIB gastric cancer treated with cisplatin, paclitaxel, and radiotherapy with or without fluorouracil vs therapy in the adjuvant arm of the intergroup adjuvant protocol 0116 (RTOG 90-18). (Arm I closed to accrual as of 6/18/03.)
  • Compare the safety and success of these regimens vs therapy in the intergroup adjuvant study.
  • Compare the toxic effects of these regimens vs therapy in the adjuvant arm of the intergroup study.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor stage (T1-2 vs T3 vs T4) and by number of involved lymph nodes (none vs 1-3 vs 4 or more). Patients are randomized to one of two treatment arms. (Arm I closed to accrual as of 6/18/03.)

  • Arm I (closed to accrual as of 6/18/03): Patients receive fluorouracil IV continuously and cisplatin IV over 1 hour on days 1-5 and 29-33 and paclitaxel IV continuously on days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and fluorouracil IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.

  • Arm II: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on days 1 and 29.

At 3-4 weeks after completion of chemotherapy, patients receive radiotherapy once daily and paclitaxel IV continuously on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study within 3 years.

Being tested
cisplatin, paclitaxel, adjuvant therapy, 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, adenocarcinoma of the esophagus
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, 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 startMay 2001
  3. Primary completionMay 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
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00011960
Sponsor's protocol ID
RTOG-G-0114
Other IDs
CDR0000068464
Status last verified
Nov 2015
First submitted
3 Mar 2001
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Schwartz GK, Winter K, Minsky BD, Crane C, Thomson PJ, Anne P, Gross H, Willett C, Kelsen D. Randomized phase II trial evaluating two paclitaxel and cisplatin-containing chemoradiation regimens as adjuvant therapy in resected gastric cancer (RTOG-0114). J Clin Oncol. 2009 Apr 20;27(12):1956-62. doi: 10.1200/JCO.2008.20.3745. Epub 2009 Mar 9.

    PubMed 19273696

  • Schwartz GK, Winter K, Minsky B, et al.: A randomized phase II trial comparing two paclitaxel (P)-cisplatin (C) containing chemoradiation (CRT) regimens as adjuvant therapy in resected gastric cancer (RTOG 0114). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1069, S169, 2006.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, paclitaxel and adjuvant therapy in people with Esophageal Cancer and Gastric Cancer, run by Radiation Therapy Oncology Group at 69 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 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 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 NCT00011960, which also lists 2 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 17 Nov 2015.

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Clinical Trial NCT00011960 | AzTrials