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Adenocarcinoma of the PancreasPhase 2NCT00096070

Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

A Phase 2 study testing radiation therapy, oxaliplatin and fluorouracil in people with Adenocarcinoma of the Pancreas and Stage II Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

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

Official record
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Trial summary

This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
radiation therapy, oxaliplatin and fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Dec 2004to Apr 2007
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Unresectable disease, including subtotal resection and gross residual disease
  • Locally advanced disease
  • No cystadenocarcinoma of the pancreas
  • No pancreatic tumors of neuroendocrine origin
  • No microscopic residual disease as only evidence of pancreatic cancer
Show all 34Show fewer
  • All disease must be encompassable within standard radiotherapy fields for pancreatic cancer
  • No distant metastases (liver or lung metastases or peritoneal spread)
  • No evidence of metastatic disease outside the planned radiotherapy field
  • Performance status - ECOG 0-1
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to maintain adequate oral nutrition
  • No significant infection
  • No significant nausea or vomiting
  • No other medical condition that would preclude study participation
  • No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7)
  • No known allergy to platinum compounds
  • No prior biologic therapy
  • No concurrent biologic therapy
  • No concurrent immunotherapy
  • No prior chemotherapy
  • No other concurrent chemotherapy
  • No prior radiotherapy that would overlap planned radiotherapy fields
  • No other concurrent radiotherapy
  • See Disease Characteristics
  • At least 21 days since prior laparotomy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer

This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplatin, and fluorouracil followed by gemcitabine.

SECONDARY OBJECTIVES:

  1. Determine overall survival, time to disease progression, and confirmed response rate in patients treated with this regimen.

II. Determine toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Being tested
radiation therapy, oxaliplatin, fluorouracil, gemcitabine hydrochloride
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • radiation therapyRadiation

    Also called irradiation, radiotherapy, therapy, radiation

    Undergo radiation therapy

  • oxaliplatinDrug

    Also called 1-OHP, Dacotin, Dacplat, Eloxatin

    Given IV

  • fluorouracilDrug

    Also called 5-fluorouracil, 5-Fluracil, 5-FU

    Given IV

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

Study groups in NCT00096070
Study groupRoleWhat they receive
Arm IExperimentalPatients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: radiation therapy; Drug: oxaliplatin; Drug: fluorouracil; Drug: gemcitabine hydrochloride

What is being measured

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

  1. 1-year survival rate

    1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.

    Measured: At 1 year

Secondary outcomes (5)

  1. Survival time

    The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to death due to any cause, assessed up to 3 years

  2. Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart

    Measured: Up to 6 months

  3. Time to disease progression

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to documentation of disease progression, assessed up to 3 years

  4. Duration of response

    Measured: Date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years

  5. Time to treatment failure

    Measured: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years

Timeline

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

  1. First posted9 Nov 2004 (estimated)
  2. Study startDec 2004
  3. Primary completionApr 2007

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096070
Sponsor's protocol ID
NCI-2012-01816
Other IDs
N0349, CDR0000391191, NCCTG-N0349, U10CA025224
Status last verified
Jun 2013
First submitted
9 Nov 2004
Last updated
16 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiation therapy, oxaliplatin and fluorouracil in people with Adenocarcinoma of the Pancreas and Stage II Pancreatic Cancer, run by National Cancer Institute (NCI) at 1 site 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 34 inclusion and 0 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 16 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 1 site 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.

What does the primary outcome measure?

1-year survival rate (time frame: At 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 NCT00096070.

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 16 Jul 2013.

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