Comparing Gemcetabine and Capecitabine versus Gemcitabine monotherapy in chemotherapy for pancreatic cancer

Phase 1

• Conditions: MedDRA version: 21.0Level: LLTClassification code 10033602Term: Pancreatic adenocarcinoma resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; Resectable pancreatic cancer

• Registration Number: EUCTR2007-004299-38-DE
• Lead Sponsor: The University of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-03
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1068

Inclusion Criteria

1.A) Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection)
or
B) Patients who have undergone complete macroscopic resection for peri-ampullary carcinoma (R0 or R1 resection).
2.Completion of all pre-operative investigations.
3.Histological confirmation of the primary diagnosis.
4.Histological examination of all resection margins.
5.Patients randomised ideally within 12 weeks of surgery, although case by case the CI will consider patients up to 14 weeks, and can begin treatment ideally within 14 weeks surgery
6.No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs – CT (chest, abdomen, pelvis) scan within 3 months prior to randomisation..
7.A WHO performance status <2
8.Creatinine clearance = 50ml/min (according to Cockcroft and Gault, or equivalent value following local practice).
9.Fully recovered from the operation and fit to take part in the trial.
10.Able to attend for administration of the adjuvant therapy.
11.Able to attend for long-term follow-up.
12.Life expectancy > 3 months.
13.No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).
14.No serious medical or psychological condition precluding adjuvant treatment.
15.Fully informed written consent given.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 534
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 534

Exclusion Criteria

1.Use of neo-adjuvant chemotherapy or other concomitant chemotherapy.
2.Patients with pancreatic lymphoma.
3.Macroscopically remaining tumour (R2 resection).
4.Patients with TNM Stage IV disease.
5.Patients younger than 18 years.
6.Pregnancy.
7.New York Heart Association Classification Grade III or IV.
8.Previous chemotherapy.
9.All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
10.Patients with known malabsorption.
11.Patients with a baseline neutrophil count of <1.5 x 109/l.
12.Patients with a baseline platelet count of <100 x 109/l.
13.Patients with severe hepatic impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1. To compare the proportion of grade 3/4 toxicity across the treatment types.<br>2. To assess Quality of Life over time and treatment groups using the EORTC-C30 questionnaire.<br>3. To investigate and compare two year survival rates for the treatments.<br>4. To investigate and compare five year survival rates for the treatments. <br>5. To assess and compare relapse free survival (RFS).<br>;Primary end point(s): Length of survival. This measure is length of survival defined as number of days between date of randomisation and date of death due to any cause (event) or date of last follow-up if patient is still alive at time of analysis (censored).;Main Objective: To investigate if combination chemotherapy (gemcitabine and capecitabine), when used as adjuvant therapy in patients following resection for pancreatic adenocarcinoma, improves survival over adjuvant therapy using gemcitabine alone.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pancreatic Ductal Adenocarcinoma:<br>1.Toxicity<br>2.Quality of life (assessed using the EORTC QLQ-C30 v3)<br>3.Two year survival <br>4.Five year survival <br>5.Relapse free survival (RFS)<br><br>Peri-Ampullary Carcinoma:<br>1.Toxicity<br>2.Quality of life<br>3.Four year survival <br>4.Relapse free survival (RFS)