Health TrialsbyHealthPanel

Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer

ConditionsPancreas CancerNon-Resectable Pancreas Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMorten Ladekarl

About this trial

The aim of the study is to compare the efficacy and toxicity of full-dose Gemcitabine and reduced-dose combination chemotherapy in patients with non-resectable pancreatic cancer, who are unfit for full-dose combination chemotherapy.

The patients will be equally randomized to arm A or arm B:

Arm A: Full-dose single agent treatment with Gemcitabine 1000 mg/m2 weekly on days 1, 8,and 15 every 4 weeks.

Arm B: Reduced-dose (80%) combination-treatment with Gemcitabine plus Nab-Paclitaxel (Gemcitabine: 800 mg/m2 plus Nab-Paclitaxel: 100 mg/m2 on day 1, 8 and 15 every 4 weeks)

Progression-free survival, overall survival and response rate will be estimated for each group, as well as toxicity and quality of life will be prospectively registered.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Adenocarcinoma of the pancreas, histopathologically or cytologically verified

Non-resectable (locally advanced or metastatic) PC

Patients unfit or not candidate for full-dose combination chemotherapy

Disqualifiers

Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation

Prior chemotherapy for PC (However, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)

Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma

Concurrent treatment with any other anti-cancer therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gemcitabine

    Drug

    Gemcitabine monotherapy, 1000 mg/m2 weekly on days 1, 8, and 15 every 4 weeks or gemcitabine: 800 mg/m2 on day 1, 8 and 15 every 4 weeks

  • Nab paclitaxel

    Drug

    Nab-Paclitaxel: 100mg/m2 on day 1, 8 and 15 every 4 weeks

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: A: "Full dose single agent strategy"Active comparator 1 intervention
Group B: B: "Reduced dose (80%) combination-therapy strategy"Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PFS (Progression Free Survival)

PFS is defined in the ITT population as the date of the randomization to the date of disease progression or date of death, whichever comes first. The date of PD is the date of scan, if progression is found on a CT scan, or date of visit at which clinical progression is found. PD at CT is defined according to RECIST version 1.1.

Time frame
1 year from end of study accrual.

Secondary outcomes

1

OS (Overall Survival)

OS is defined in the ITT population as the date of randomization to date of death of all causes.

Time frame
1 year from end of study accrual.
2

RR (Response rate)

In patients with measurable disease at baseline, RECIST version 1.1 will be used for evaluation of complete response (CR), partial response (PR), stable disease (SD) or PD. ORR will be calculated as the percentage of patients with CR+PR of all patients with measurable disease, who received at least one treatment and were evaluated by at least one diagnostic CT scan.

Time frame
1 year from end of study accrual.
3

Hospitalizations

The total number of hospital admissions in a stationary unit with overnight stay from the start of treatment to the date of end of treatment will be assessed in the treated population. If the patient is readmitted for the same reason within 3 days (e.g., after weekend leave), this is not counted as a separate admission. The reasons for admission are registered as toxicity due to treatment or symptoms due to PC. The sum of hospitalizations is calculated for each randomization arm for comparison.

Time frame
Through study completion, an average of 6 months.
4

Quality of Life (QOL) assessed by EORTC QLQ-C30 at baseline and after 8, 16, and 24weeks

QoL scores collected will be linearly transformed to a scale of 0 to 100. Items will be grouped in health status scale (range 0 - 100, high is better), functional scales (range 0 - 100, high is better) and symptom scales (range 0 - 100, low is better). Each scale is summarized by its mean, and standard deviation for the patients in the two treatment groups. The difference in mean at 8, 16 and 24 weeks are compared with the baseline mean within in each treatment groups. The difference in mean between the treatment groups are compared at baseline, 8, 16 and 12 weeks.

Time frame
At baseline and at 8, 16, and 24 weeks.

Other outcomes

Sponsors and contacts

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

Morten Ladekarl

Lead sponsor

Aalborg University Hospital

Sponsor institution

Aarhus University Hospital

Collaborator

Odense University Hospital

Collaborator

Herlev and Gentofte Hospital

Collaborator

Gødstrup Hospital

Collaborator

Vejle Hospital

Collaborator

Source ClinicalTrials.gov
Apply now