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CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence

ConditionsBiliary Tract CancerCholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGruppo Oncologico del Nord-Ovest

About this trial

PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in terms of 12-month PFS rate (phase II part) and PFS (phase III part) in patients with resectable BTC at high risk for recurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures.

Female and male patients ≥18 years and <75 years.

Histologically or cytologically confirmed non metastatic resectable carcinoma of biliary tract (BTC), including gallbladder carcinoma (GBC), intrahepatic, periperihilar or distal Cholangiocarcinoma (CCA). Mixed tumor entities with hepatocellular carcinoma and ampullary cancers are excluded.

Availability of a tumoral sample

Disqualifiers

Known allergy or hypersensitivity to any of the study drugs.

Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer.

Locally unresectable tumor according to local MDT (including radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow, and sufficient future liver remnant).

Evidence of distant metastases at any site.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gemcitabine

    Drug

    ◦ Gemcitabine 800 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

  • Nab paclitaxel

    Drug

    ◦ Nab-paclitaxel 100 mg/mq, day 1 and 8 of 21-day cycles, for 3 cycles

  • Cisplatin

    Drug

    ◦ Cisplatin 25 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

  • Curative Surgery

    Procedure/Surgery

    Curative surgery on primary tumor

  • Capecitabine

    Drug

    1250 mg/m2 given orally twice daily on days 1 to 14 of a 3 weekly cycle for a total of 8 cycles

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Preoperative chemotherapyExperimental treatment 5 interventions
Group B: Upfront surgeryActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

12-month progression-free survival (PFS) rate

the proportion of patients alive and free from progression/post-resection recurrence by 12-months timepoint from randomization (to be considered as primary endpoint in the phase II part of the study and as secondary endpoint in the phase III part of the study).

Time frame
12 months
2

median PFS

i.e. the time from randomization to disease progression, post-resection recurrence or death from any cause (to be considered as secondary endpoint in the phase II part of the study and as primary endpoint in the phase III part of the study).

Time frame
From date of randomization until the date of first documented progression (as assessed by radiological evaluation and clinical examination) or date of death from any cause, whichever came first, assessed up to 120 months

Secondary outcomes

1

Median event free survival

i.e. the time from randomization to disease progression that precludes definitive surgery, treatment discontinuation for any reason, post-resection recurrence, a second primary cancer, or death from any cause.

Time frame
from date of randomization to disease progression that precludes definitive surgery, treatment discontinuation for any reason, post-resection recurrence, diagnosis of second cancer, or death from any cause, assessed up to 120 months
2

Median relapse free survival

i.e. the time from surgery to disease recurrence or death in patients who undergo to surgery with curative intent.

Time frame
from date of surgery to date of disease recurrence or date of death, whichever came first, in patients who undergo surgery with curative intent, assessed up to 120 months.
3

Median Overall survival

i.e. the time from randomization to death or last follow-up for alive patients.

Time frame
from date of randomization to date of death (or last follow up for alive patients), assessed up to 120 months.
4

R0 resection rate

i.e. the percentage of patients, relative to the total of randomized patients, for whom a R0 resection is achieved.

Time frame
At surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gruppo Oncologico del Nord-Ovest

Lead sponsor

Source ClinicalTrials.gov
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