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Pancreatic CancerPhase 2NCT01867892

A Phase II Study of Locally Advanced Pancreatic Cancer

A Phase 2 study testing ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT and ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT in people with Pancreatic Cancer, run by National Health Research Institutes, Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary end point is to evaluate the 9-month progression free survival rate and safety profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT and ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
No sites listed yet
Study dates
Jun 2013to May 2019
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas.
  • Patients must have locally advanced pancreatic cancer (LAPC).
  • Patients must have LAPC evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
  • Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
  • extension to the celiac axis or superior mesenteric artery,
  • occlusion of the superior mesenteric-portal venous confluence
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  • aortic, inferior vena cava (IVC) invasion or encasement
  • invasion of SMV below transverse mesocolon or unresectable after surgical exploration.
  • Those who had superior mesenteric vein impingement, superior mesenteric artery abutment were defined as borderline resectable.
  • Those who had superior mesenteric vein occlusion, superior mesenteric artery encasement were defined as unresectable.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
  • Age >20 years and ≦70 years.
  • ECOG performance score of 0 or 1; see Appendix A.
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count >1,500/mL
  • platelets >100,000/mL
  • total bilirubin <1.5X institutional upper limit of normal
  • ALT(SGPT) <5 X institutional upper limit of normal
  • creatinine within normal institutional limits or creatinine clearance>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Patients who present with jaundice will be allowed to enroll after control with temporary or permanent internal/external drainage.
  • The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing 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 with distant metastases are not eligible.
  • Patients with endocrine or acinar pancreatic carcinoma.
  • Patients may be receiving any steroid, immunologic or other investigational agents within 4 weeks prior to enrollment.
  • Patients who have had prior chemotherapy or radiotherapy are not eligible.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
  • Patients who have above grade II peripheral neuropathy.
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  • Patients who had non-curable second primary malignancy within five years, except for non-melanoma skin cancer.
  • 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.
  • Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
  • Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded from the study because of increased risk of lethal infections and possible pharmacokinetic interactions with study agent administered during the study.
  • Those who have chronic diarrhea.

About this study

Official title: A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer

The primary end point is to evaluate the 9-month progression free survival rate and safety profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.

The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.

Read the detailed description

Patients should be randomized to two study arms stratified by resectability status (borderline resectable and unresectable) after enrollment. Eligible patients will be randomly assigned on a 1:1 basis to either of two study groups, using a central randomization procedure with stratification according to NCCN criteria of resectability.

After randomization, induction chemotherapy (ICT) will be administered for 3 cycles (3 months). Patients who have radiological evidence of distant dissemination will be shifted to salvage chemotherapy. Patients who have responsive, stable disease as well as those with localized progressive disease after ICT will receive concurrent chemoradiotherapy (CCRT) 3-4 weeks after the last dose of ICT. Surgical evaluation will be performed 4-6 weeks after the completion of CCRT. Patients who have respectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy for 3 cycles (3 months) will be given for those who are considered to have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy till disease progression or unacceptable toxicity.

For Arm 1, ICT with FOLFIRINOX ( oxaliplatin 85mg/m2 for 2 hr, irinotecan 180mg/m2 for 90 min and 5FU 3000mg/m2 + LV 150mg/m2 continuous infusion 48 hr) will be administered biweekly. For Arm 2, ICT with GOFL ( 800mg/m2 gemcitabine at a fixed rate of 10mg/m2/min followed by a 2-hour oxaliplatin 85mg/m2 and then a 48-hour 3000mg/m2 5-FU and 150 mg/m2 leucovorin on day 1 and 15 every 28 days/cycle) will be given biweekly.

After three 3 cycles of ICT, patients without distant metastasis will be given CCRT with 5-FU 450mg/m2 in Arm 1, gemcitabine 400mg/m2 in Arm 2, 2 hrs before RT on day1,8,15,22,29,36. Radiation will be given 180cGy per day, 5 days a week for 28 fractions to totally 5040cGy.

If complete surgical resection is feasible, optimal surgery will be performed 4-6 weeks after CCRT. If complete surgical resection is impossible, biopsy with or without bypass surgery may be performed. Patients who have curative surgical resection will receive additional 6 cycles ( 6 months) of adjuvant chemotherapy ( Arm1, FOLFIRINOX, Arm 2, GOFL) within 4 weeks after surgery and then followed up until tumor progression. Patients who are not feasible for curative resection, will receive continued chemotherapy (Arm1, FOLFIRINOX; Arm2, GOFL) 3-4 weeks after CCRT complete. The regimen will continue till disease progression.

Being tested
ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT, ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT
Keywords
Locally Advanced Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRTDrug

    Also called ICT of oxapliplatin,irinotecan,leucovorin,and fluorouracil and CCRT

    oxapliplatin ,irinotecan ,5FU +leucovorin ,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly

  • ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRTDrug

    Also called ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil +CCRT

    Gem ,Oxa ,5FU +LV ,RT 5,040cGy in 28 fractions/5.5 wks and Gem 400mg/m2 iv 40min weekly

Study groups in NCT01867892
Study groupRoleWhat they receive
ICT of oxaliplatin,irinotecan,5-FU and leucovorinon and CCRTExperimentalArm1:oxaliplatin,irinotecan,5-FU and leucovorinon D1,15 every 28days for 3 cycles,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly
Receives: Drug: ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT
ICT of gemcitabine,oxaliplatin,5-FU,leucovorin and CCRTActive comparatorArm 2:gemcitabine,oxaliplatin,5-FU,leucovorin on D1,15 every 28 days for 3 cycles,Evaluation of Tumor Response,CR/PR/SD or localized disease RT 5,040cGy in 28 fractions/ 5.5 wks Arm 2: Gem 400mg/m2 iv 40min weekly
Receives: Drug: ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT

What is being measured

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

  1. the response rate, disease control rate, overall survival, and patients' quality of life.

    This is a randomized phase II trial of ICT followed by CCRT with radiotherapy in LAPC. The efficacy will be primarily measured by progression free survival (PFS) as defined in Section 8.5.Other measurements include the response rate, disease control rate, overall survival, and patients' quality of life as described in Section 8.We anticipate that the attrition rate is about 10%, hence, roughly 86 patients will be recruited , we anticipate that the recruitment will be completed in 4.5 years.

    Measured: 4.5 years

Timeline

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

  1. First posted4 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionMay 2018 (estimated)
  4. Study completionMay 2019 (estimated)

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
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01867892
Sponsor's protocol ID
T2212
Status last verified
May 2013
First submitted
7 May 2013
Last updated
4 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Su YY, Chiu YF, Li CP, Yang SH, Lin J, Lin SJ, Chang PY, Chiang NJ, Shan YS, Ch'ang HJ, Chen LT. A phase II randomised trial of induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer: the Taiwan Cooperative Oncology Group T2212 study. Br J Cancer. 2022 Apr;126(7):1018-1026. doi: 10.1038/s41416-021-01649-7. Epub 2021 Dec 17.

    PubMed 34921230

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT and ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT in people with Pancreatic Cancer, run by National Health Research Institutes, Taiwan.

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 22 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: status not confirmed, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

the response rate, disease control rate, overall survival, and patients' quality of life. (time frame: 4.5 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 NCT01867892, 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 4 Jun 2013.

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