fluorouracil and Carcinoma, Pancreatic Ductal

fluorouracil has been researched along with Carcinoma, Pancreatic Ductal in 243 studies

Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.
5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.

Carcinoma, Pancreatic Ductal: Carcinoma that arises from the PANCREATIC DUCTS. It accounts for the majority of cancers derived from the PANCREAS.

Research

Studies (243)

Authors

Clinical Trials (40)

Trial Overview

Trial Outcomes

Disease-free Survival From the Time of R0 or R1 Resection.

Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact. (NCT02562716)
Timeframe: Up to 4 years

Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02562716)
Timeframe: Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).

Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.

R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins). (NCT02562716)
Timeframe: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.

(NCT02562716)
Timeframe: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

Overall Survival (OS)

OS is the length of time between protocol registration and patient death (NCT02562716)
Timeframe: Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported. (NCT02562716)
Timeframe: Duration of treatment and follow up until death or 4 years post registration.

Objective Response Rate

The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS. (NCT01494506)
Timeframe: Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.

Overall Survival

"Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol." (NCT01494506)
Timeframe: From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.

Percentage of Patients With Clinical Benefit Response

"Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either:~(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.~With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.~Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period." (NCT01494506)
Timeframe: Randomization to treatment discontinuation.The maximum time in follow up was 25 months

Percentage of Patients With Tumor Marker (CA 19-9) Response

Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period. (NCT01494506)
Timeframe: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months

Progression Free Survival

"Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol." (NCT01494506)
Timeframe: Randomization until disease progression or death from any cause; Until the data cut off of 14 Feb 2014. The maximum time in follow up was 25 months.

Time to Treatment Failure

Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death. (NCT01494506)
Timeframe: Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months

EORTC-QLQ-C30

This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement. (NCT01494506)
Timeframe: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months

Pharmacokinetic Measurements of Total Irinotecan

Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods. (NCT01494506)
Timeframe: 6 weeks after first study drug administration

Duration of Response (DOR)

DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT02923921)
Timeframe: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

Overall Survival

Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date. (NCT02923921)
Timeframe: Randomization to date of death from any cause (Up To 30 Months)

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator

ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response. (NCT02923921)
Timeframe: Randomization to PD (Up To 30 Months)

Percentage of Participants Alive at 1 Year (12-Month Survival Rate)

The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization. (NCT02923921)
Timeframe: From randomization to until the date of first documented date of death from any cause within 12 months

Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. (NCT02923921)
Timeframe: Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)

Progression Free Survival

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant. (NCT02923921)
Timeframe: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)

Recurrence Free Survival

Time from surgery to recurrence (NCT00313560)
Timeframe: Up to 3 years

Time to Death as Assessed by Median Overall Survival (Months)

(NCT00313560)
Timeframe: up to 5 years

Change in QoL as Assessed by QLQ-PAN 26

Quality of life (QOL) was assessed before CRT was started or during the first week of its administration (baseline [BL]), between completion of CRT and starting maintenance chemotherapy (time 1 [t1]), and within 3 months after completion of maintenance chemotherapy (time 2 [t2]). QLQ-PAN 26 questionnaire includes 26 questions, organized into 7 scales, with scores for each ranging from 0-100. Higher scores indicate worse health state. Therefore, decreasing (negative) scores indicate a better outcome. (NCT00313560)
Timeframe: 3 months

Change in Quality of Life (QoL) as Assessed by EORTC QLQ-C30 (Version 3.0)

Quality of life (QOL) was assessed before chemoradiation therapy (CRT) was started or during the first week of its administration [baseline (BL)], between completion of CRT and starting maintenance chemotherapy [time 1 (t1)], and within 3 months after completion of maintenance chemotherapy [time 2 (t2)]. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses quality of life on three domains: symptoms (score ranges from 7-14); function (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes. (NCT00313560)
Timeframe: Up to 3 months after completion of maintenance chemotherapy

Number of Participants Experiencing Adverse Events

Number of participants experiencing adverse events during chemoradiation and during adjuvant chemotherapy, Grade 2 or higher, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. This is used to determine the Toxicity profile. (NCT00313560)
Timeframe: up to 3 years

30-Day Post Operative Mortality

The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy. (NCT00438256)
Timeframe: 30 days after the time of surgery (Surgery is 28-42 days after start of treatment)

Median Progression Free Survival

"The median amount of time from the start of treatment until death or disease progression, whichever occurs first.~Progressive Disease (PD): A 20% or greater increase in the sum of Longest Diameter (LD) of all target lesions, taking as reference the smallest sum LD recorded since baseline." (NCT00438256)
Timeframe: from the start of treatment until death or progression, median duration of 10.4 months

Number of Participants With a Pathological Complete Response

All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen. (NCT00438256)
Timeframe: at the time of surgery (28-42 days after start of treatment)

Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm

"The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included:~Any grade 3 non-hematologic or hematologic toxicity requiring a greater than 7 day interruption in therapy (excluding alopecia and nausea/vomiting not controlled by optimal supportive care or~Any grade 4 non-hematologic toxicity or~Any grade 4 neutropenia or thrombocytopenia as defined by Common Terminology Criteria for Adverse Events (CTCAE v3.0)" (NCT00438256)
Timeframe: 3 Weeks

Number of Participants With Grade 3 or Greater Toxicity in Phase II

Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity. (NCT00438256)
Timeframe: 30 days after the end of treatment, up to approximately 6 months total

Number of Participants With Surgical Morbidity

Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery (NCT00438256)
Timeframe: 30 days post surgery (surgery was 28-42 days after the start of treatment)

Number of Participants With Treatment Related Serious Adverse Events

The number of participants that had treatment related serious adverse events. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). Adverse events were considered to be serious adverse events if they were grade 3 or greater and were considered to be possibly, probably, or definitely related to treatment. (NCT00438256)
Timeframe: From the start of treatment until 30 days after the end of treatment, up to approximately 5 months

Reviews

35 reviews available for fluorouracil and Carcinoma, Pancreatic Ductal