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Unresectable Pancreatic CancerPhase 2NCT02035072

Phase II Study of Hypofractionated Radio-chemotherapy With Gemcitabine Plus Oxaliplatin for Unresectable Nonmetastatic Locally Advanced Pancreatic Cancer.

A Phase 2 study testing Gemcitabine, Oxaliplatin and Hypofractionated RT in people with Unresectable Pancreatic Cancer and Nonmetastatic Pancreatic Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

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

Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer. Protocol code: IRST157.01 Phase: II Study Design: monocentric, prospective, open-label not randomized trial. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Gemcitabine, Oxaliplatin and Hypofractionated RT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
Nov 2010to Dec 2016
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically or cytologically confirmed diagnosis of pancreatic cancer are candidates for the trial.
  • Stage III disease (AJCC TNM 6th edition, 2002). Inoperable disease, by radiological and surgical evaluation;
  • Age >18 years and ≤75 years.
  • Life expectancy of greater than 12 weeks.
  • ECOG performance status 0-2 (see Appendix A).
  • Presence of at least of one measurable lesion in agreement to RECIST criteria
Show all 15Show fewer
  • Patients must have normal organ and marrow function as defined below:
  • Leukocytes >3,000/uL
  • Absolute neutrophil count >1,500/uL
  • Platelets >100,000/uL
  • Total bilirubin < 1.5 X ULN
  • AST (SGOT)/ALT (SGPT) <2.5 X ULN
  • Creatinine < 1.5 X ULN
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients who have had any chemotherapy or radiotherapy prior to entering the study;
  • Stage IV disease;
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  • Previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors, or other malignancies curatively treated >5 years before study entry.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and oxaliplatin or other agents used in the study.
  • Active brain or leptomeningeal disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Radiotherapy Unit, IRCCS IRST

    Meldola, FC, 47014

Other trials in Italy

About this study

Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer.

Protocol code: IRST157.01

Read more

Phase: II

Study Design: monocentric, prospective, open-label not randomized trial.

Description of Study Treatment: radio-chemotherapy schedule

  • GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every 2 weeks for 4 cycles.
  • Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy cycle.
  • Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy.

Objectives:

Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary objective = the control of IM (internal margin) intra-fraction.

Step B: primary objective = to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of combinated treatment;overall survival (OS); local progression free survival (LPFS) and progression free survival (PFS).

Statistical Considerations:

Step A:

Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients, the treatment can be considered safe with a probability > 90%. If 1 toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more patients needs to be recruited. If no further toxicity involving the radiotherapy treatment discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%.

If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed, the study will be stopped because not safe and another kind of radiotherapy schedule must be designed.

Step B:

If the radiotherapy treatment will be considered no toxic, the study will continue in Step B : the goal of this phase II study is to increase the proportion of resectable patients of at least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years, and a further one-year period of follow-up is requested. If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active.

Being tested
Gemcitabine, Oxaliplatin, Hypofractionated RT

What participants receive

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

  • GemcitabineDrug

    Gemcitabine 1000 mg/m2

  • OxaliplatinDrug

    Also called oxalipaltin

    Oxaliplatin 100 mg/m2

  • Hypofractionated RTRadiation

    Hypofractionated radiotherapy (35 Gy in 7 fractions)

Study groups in NCT02035072
Study groupRoleWhat they receive
Hypofractionated RT + Gem + OxaliExperimentalHypofractionated radiotherapy + Gemcitabine + Oxaliplatin
Receives: Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Hypofractionated RT

What is being measured

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

  1. Toxicity

    If no toxicity in 11 patients, the treatment can be considered safe with a probability > 90%.

    If 1 toxicity will be observed, 7 more patients needs to be recruited. If no further toxicity occurs, the treatment could be considered safe with a probability ≥ 90%.

    If 2 or more toxicity in 11 patients or 2 or more in18 patients will be observed, the study will be stopped because not safe.

    Measured: 15 months after the start of recruitment

  2. Proportion of resectable patients

    If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active.

    Measured: 3 years after the start of recruitment

Secondary outcomes (4)

  1. Objective tumor response

    It is assessed using RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

    Measured: 3 years after the start of recruitment.

  2. Objective tumor response rate (ORR)

    It is defined as the proportion of the intention-to-treat (ITT) population showing a complete or partial response, if confirmed ≥ 4 weeks later.

    Measured: 3 years after the start of recruitment.

  3. Overall survival (OS)

    It is counted from the date of registration to the date of death due to any cause or last date the patient was known to be alive (censored observation).

    Measured: 3 years after the start of recruitment

  4. Progression free survival (PFS/local PFS)

    It is counted from the date of registration to the date of the first observation of documentation of objective disease progression/local disease progression or death due to any cause, whichever occurs first.

    Measured: 3 years after the start of recruitment

Timeline

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

  1. First posted14 Jan 2014 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02035072
Sponsor's protocol ID
IRST157.01
Other IDs
2010-020379-22
Status last verified
Jul 2017
First submitted
10 Jan 2014
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Oxaliplatin and Hypofractionated RT in people with Unresectable Pancreatic Cancer and Nonmetastatic Pancreatic Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

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 15 inclusion and 7 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 Jul 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 Italy. 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?

Toxicity (time frame: 15 months after the start of recruitment). The study lists 2 primary outcomes in all. 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 NCT02035072.

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 Jul 2017.

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