Adjuvant Chemotherapies in Resectable Pancreatic Cancer

Phase 3

Active, not recruiting

• Conditions: Histologically proven ductal or ampullary cancer of the pancreas having undergone 'curative' resection; Cancer - Pancreatic

• Registration Number: ACTRN12605000361606
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group (AGITG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1090

Inclusion Criteria

* Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection) or patients with other cancers may be included who have had complete macroscopic resection (R0 or R1 resection) for (i) unusual malignancies of the pancreas, such as acinar cell carcinoma, cystadenocarcinoma etc.; (ii) cancers of the periampullary region; (iii) cancers of the intra-pancreatic part of the bile duct; (iv) periampullary cancers of uncertain origin. Patients with tumours as in 1(b) will be analysed separately and will be in addition to the recruitment of pancreatic cancer patients.* Histological confirmation of the primary diagnosis.* Histological examination of all resection margins.* No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs.* WHO performance status < 2* Fully recovered from the operation and fit to take part in the trial. Life-expectancy of more than 3 months.* Able to attend for administration of the adjuvant therapy.* Able to attend for long-term follow-up.* No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).* No serious medical or psychological condition precluding adjuvant treatment.* Fully informed written consent given.

Exclusion Criteria

* Use of neo-adjuvant chemotherapy or other concomitant chemotherapy.
* Patients with pancreatic lymphoma.
* Macroscopically remaining tumour (R2 resection)
* Patients with TNM Stage IVb disease.
* Patients younger than 18 years.
* Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified