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Pancreatic CancerPhase 2NCT01430052

Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer

A Phase 2 study testing Drug: gemcitabine, S-1 and gemcitabine, S-1, radiotherapy in people with Pancreatic Cancer, run by Osaka Medical Center for Cancer and Cardiovascular Diseases at 1 site in Japan.

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

The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Drug: gemcitabine, S-1 and gemcitabine, S-1, radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteJapan
Study dates
Apr 2009to Sep 2015
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
  • Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below.
  • Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.)
  • Involving over the merging section of portal-SMV.
  • No distal metastasis with diagnostic imaging.
  • Confirmed by CT image performed with in four weeks before registration.
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  • Performance Status:0-1(ECOG)
  • Patients of age =>20 and 80>
  • sufficient organ functions
  • neutrophils>=1,500/mm3
  • platelets>=100,000/mm3
  • hemoglobin>=9.0g/dl
  • AST(GOT)/ALT(GPT) <=150IU
  • total bilirubin <=2.0mg/dl, (or <=3.0mg/dl if biliary drainage were present)
  • serum creatinine <= 1.2mg/dl
  • creatinine clearance>=60ml/min
  • Life expectancy more than 3 months.
  • Written informed consent.

Who cannot join

  • Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
  • Watery diarrhea
  • Severe infection
  • Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
  • Massive pleural or abdominal effusion.
  • Metastasis to central nervous system.
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  • Active synchronous or metachronous malignancy other than carcinoma in situ.
  • Regular use of flucytosine, fenitoin or warfarin
  • Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
  • Severe mental illness
  • Patients who are judged inappropriate for the entry into the study by the investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 537-8511

Other trials in Japan

About this study

Official title: Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.

The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.

Read the detailed description

When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular.

In comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. In the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. This decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt.

We will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or S-1, not 5FU, predominantly from our own clinical trials on this occasion.

Being tested
Drug: gemcitabine, S-1, gemcitabine, S-1, radiotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Drug: gemcitabine, S-1Drug

    Also called gemzer, TS-1

    Gemcitabine 1,000mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks.

  • gemcitabine, S-1, radiotherapyDrug

    Also called gemzer, TS-1

    Gemcitabine 600mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.

Study groups in NCT01430052
Study groupRoleWhat they receive
Gemcitabine , S-1OtherGemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks
Receives: Drug: Drug: gemcitabine, S-1
Gemcitabine, S-1, radiotherapyExperimentalGemcitabine 600mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks with radiotherapy 50.4Gy in 28 fractions
Receives: Drug: gemcitabine, S-1, radiotherapy

What is being measured

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

  1. Two year survival rate

    Measured: 2 years

Secondary outcomes (4)

  1. Progression free survival（PFS）

    Measured: 4 years

  2. Overall Survival (OS)

    Measured: 4 years

  3. Adverse events

    Measured: 4 years

  4. Response rate

    Measured: 4 years

Timeline

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

  1. First posted7 Sep 2011 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2012
  4. Study completionSep 2015

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01430052
Sponsor's protocol ID
TatsuyaIoka
Other IDs
UMIN000001990
Status last verified
Apr 2015
First submitted
5 Sep 2011
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drug: gemcitabine, S-1 and gemcitabine, S-1, radiotherapy in people with Pancreatic Cancer, run by Osaka Medical Center for Cancer and Cardiovascular Diseases at 1 site in Japan.

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 18 inclusion and 11 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 21 Nov 2017. 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 Japan. 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?

Two year survival rate (time frame: 2 years). 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 NCT01430052.

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 21 Nov 2017.

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