AzTrials
AzTrials

Gastric CancerPhase 2NCT00003298

Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer

A Phase 2 study testing cisplatin, fluorouracil and leucovorin calcium in people with Gastric Cancer, run by ECOG-ACRIN Cancer Research Group at 30 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, radiation therapy, and surgery may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
cisplatin, fluorouracil and leucovorin calcium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
30 sitesUnited States
Study dates
1 Jun 1999to May 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
  • Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0)
  • No metastatic cancer to the ovaries
  • Age: 18 and over
  • Easter Cooperative Oncology Group (ECOG) performance status 0-2
  • White blood cell (WBC) count at least 4,000 cells/mm3
Show all 21Show fewer
  • Platelet count at least 150,000/mm3
  • Bilirubin less than 2 mg/dL
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance greater than 50 mL/min
  • Caloric intake must be at least 1500 kcal/day
  • No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No prior radiation therapy, except for skin cancer
  • Fertile patients must use adequate contraception
  • Met criteria for re-registration after surgery
  • T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration.
  • No evidence of metastatic disease from postoperative pathologic staging.
  • ECOG performance status of 0, 1, or 2 at re-registration
  • Curative resection performed
  • Re-registered 4 - 6 weeks from the date of surgery
  • WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration

Who cannot join

  • Prior chemotherapy
  • Clinically significant auditory impairment
  • Significant heart disease
  • Pregnant or lactating

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611-3013

  • Veterans Affairs Medical Center - Lakeside Chicago

    Chicago, Illinois, 60611

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962-1956

  • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

    Nashville, Tennessee, 37212

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Raritan Bay Medical Center

    Perth Amboy, New Jersey, 08861

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Somerset Medical Center

    Somerville, New Jersey, 08876

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: A Phase II Trial of Neoadjuvant Paclitaxel - Cisplatin Chemotherapy, Surgery and Adjuvant Radiation Therapy and 5-FU/Leucovorin for Gastric Cancer

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, radiation therapy, and surgery may kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.

Read the detailed description

OBJECTIVES:

Primary objective: To evaluate the tolerability and toxicity of neoadjuvant cisplatin plus paclitaxel and postoperative chemoradiation therapy with fluorouracil plus leucovorin calcium in patients with high-risk gastric cancer.

Secondary objectives: To assess the pathologic response of gastric tumors to neoadjuvant cisplatin plus paclitaxel chemotherapy, and preliminarily assess the patterns of failure and disease free and overall survival.

OUTLINE: Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment. Patients are followed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter.

PROJECTED ACCRUAL: Approximately 30-42 patients will be accrued over 18 months.

Conditions
Gastric Cancer
Keywords
stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • cisplatinDrug

    Also called Platinol, cis-platinum, cisdiamminedichloroplatinum (II), Platinol-AQ

    Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.

  • fluorouracilDrug

    Also called 5-Fluorouracil, 5-FU, Adrucil, Efudex

    Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin

  • leucovorin calciumDrug

    Also called Leucovorin, Wellcovorin, citrovorum factor, folinic acid

    Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.

  • paclitaxelDrug

    Also called Taxol®, NSC 125973

    Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.

  • surgeryProcedure or surgery

    The surgical procedure performed involved a radical subtotal or total gastrectomy.

    A complete surgical resection was required

  • radiation therapyRadiation

    Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy

Study groups in NCT00003298
Study groupRoleWhat they receive
Experimental ArmExperimentalPatients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
Receives: Drug: cisplatin; Drug: fluorouracil; Drug: leucovorin calcium; Drug: paclitaxel; Procedure: surgery; Radiation: radiation therapy

What is being measured

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

  1. Grade 3 or Higher Toxicity Incidence on Step 1

    Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.

    Measured: assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)

Secondary outcomes (3)

  1. Best Confirmed Response to Neoadjuvant Therapy

    Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.

    Measured: Assessed at surgery time (surgery performed during week 8-10 after registration to the study)

  2. Overall Survival

    Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.

    Measured: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10

  3. Progression Free Survival

    Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.

    Measured: assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10

Timeline

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

  1. First posted23 Jan 2004 (estimated)
  2. Study start1 Jun 1999
  3. Primary completionFeb 2010
  4. Study completionMay 2011

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003298
Sponsor's protocol ID
CDR0000066237
Other IDs
E7296, U10CA023318, NCT00003298
Status last verified
Jun 2023
First submitted
1 Nov 1999
Last updated
6 Jul 2023
Data monitoring committee
No

Publications

  • Chakravarthy AB, Catalano PJ, Mondschein JK, Rosenthal DI, Haller DG, Whittington R, Spitz FR, Wagner H, Sigurdson ER, Tschetter LK, Bayer GK, Mulcahy MF, Benson AB. Phase II Trial of Paclitaxel/Cisplatin Followed by Surgery and Adjuvant Radiation Therapy and 5-Fluorouracil/Leucovorin for Gastric Cancer (ECOG E7296). Gastrointest Cancer Res. 2012 Nov;5(6):191-7.

    PubMed 23293700

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, fluorouracil and leucovorin calcium in people with Gastric Cancer, run by ECOG-ACRIN Cancer Research Group at 30 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?

The sponsor lists 21 inclusion and 4 exclusion criteria. 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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 23 Jun 2015). 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?

Grade 3 or Higher Toxicity Incidence on Step 1 (time frame: assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)). 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 NCT00003298, 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 6 Jul 2023.

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