The (cost)effectiveness of neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine based chemoradiotherapy and adjuvant gemcitabine for (borderline) resectable pancreatic cancer.

The (cost)effectiveness of neoadjuvant FOLFIRINOX versus neoadjuvant gemcitabine based chemoradiotherapy and adjuvant gemcitabine for (borderline) resectable pancreatic cancer. - PREOPANC-2

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55463

Enrollment

368

Registered

2018-01-22

Start date

2018-06-05

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(borderline) resectable pancreatic cancer pancreatic cancer

Interventions

8 cycles of neoadjuvant FOLFIRINOX chemotherapy followed by surgery.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma) • (Borderline) resectable tumor without metastatic disease • WHO performance status 0 or 1 • Ability to undergo surgery, chemoradiotherapy and chemotherapy • Leucocytes (WBC) >= 3.0 X 109/l (should be assesed within 4 weeks prior to randomization) • Platelets >= 100X 109 /l (should be assesed within 4 weeks prior to randomization) • Hemoglobin >= 6 mmol/l (should be assesed within 4 weeks prior to randomization) • Renal function: E-GFR >= 50 ml/min (should be assesed within 4 weeks prior to randomization) • Age >= 18 years • Written informed consent

Exclusion criteria

Exclusion criteria: • Prior radiotherapy, chemotherapy, or resection for pancreatic cancer. • Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX. • Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET)

Design outcomes

Primary

Measure	Time frame
The main endpoint is overall survival (OS).	—

Secondary

Measure	Time frame
• Chemotherapy rate, defined as the percentage of eligible randomized patients who received at least one cycle of chemotherapy. • Chemotherapy completion rate, defined as the percentage of eligible randomized patients who completed all cycles of scheduled chemotherapy. • Staging laparoscopy rate, defined as the percentage of eligible randomized patients that actually underwent a staging laparoscopy, regardless whether a laparotomy or resection was performed. • Laparoscopy yield, defined as the percentage of patients that underwent staging laparoscopy and were diagnosed with metastatic disease during this procedure. • Exploratory laparotomy rate, defined as the percentage of eligible randomized patients who actually underwent an exploratory laparotomy, regardless whether a resection was performed. • Resection rate, defined as the percentage of eligible randomized patients that underwent a curative-intent resection. • R0 resection rate, defined as the percentage of eligible randomized patients that underwent a microscopically complete (R0) resection. The resection is considered R0 if the inked margin is more than 1 mm away from tumor cells. • Progression-free survival, defined as survival without progressive or recurrent pancreatic cancer from the date of randomization. Death from any cause is also considered an event for this endpoint. • Locoregional recurrence free interval (LRFI), defined as the period of time without locoregional recurrence after randomization. A locoregional failure is any persistent or recurrent pancreatic cancer in the original tumor location, or the N1 lymph node areas. • Distant metastases free interval (DMFI), defined as the period of time without distant metastases after randomization. • Disease free survival (DFS), defined as the period of time between randomization and locoregional recurrence, occurrence of distant metastases or second pancreatic cancer, or death (all causes). • Locoregional recurrence free i	—

Measure

Time frame

• Chemotherapy rate, defined as the percentage of eligible randomized patients who received at least one cycle of chemotherapy. • Chemotherapy completion rate, defined as the percentage of eligible randomized patients who completed all cycles of scheduled chemotherapy. • Staging laparoscopy rate, defined as the percentage of eligible randomized patients that actually underwent a staging laparoscopy, regardless whether a laparotomy or resection was performed. • Laparoscopy yield, defined as the percentage of patients that underwent staging laparoscopy and were diagnosed with metastatic disease during this procedure. • Exploratory laparotomy rate, defined as the percentage of eligible randomized patients who actually underwent an exploratory laparotomy, regardless whether a resection was performed. • Resection rate, defined as the percentage of eligible randomized patients that underwent a curative-intent resection. • R0 resection rate, defined as the percentage of eligible randomized patients that underwent a microscopically complete (R0) resection. The resection is considered R0 if the inked margin is more than 1 mm away from tumor cells. • Progression-free survival, defined as survival without progressive or recurrent pancreatic cancer from the date of randomization. Death from any cause is also considered an event for this endpoint. • Locoregional recurrence free interval (LRFI), defined as the period of time without locoregional recurrence after randomization. A locoregional failure is any persistent or recurrent pancreatic cancer in the original tumor location, or the N1 lymph node areas. • Distant metastases free interval (DMFI), defined as the period of time without distant metastases after randomization. • Disease free survival (DFS), defined as the period of time between randomization and locoregional recurrence, occurrence of distant metastases or second pancreatic cancer, or death (all causes). • Locoregional recurrence free i

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)