Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

Conditions

• Adenocarcinoma of Ampulla
• Ductal Adenocarcinoma of Pancreas

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Gemcitabine and nanoparticle albumin bound paclitaxel — DRUG
  Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles
• 5-fluorouracil and irinotecan — DRUG
  FOLFIRI.3 given every 14 days x 4 cycles
• Preoperative chemoradiation — RADIATION
  Pre-operative chemoradiation to 40 Gy in 20 fractions
• Definitive resection — PROCEDURE
  Definitive surgical resection of primary tumor

Study Details

Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Key Dates

Start date

May 11, 2016

Status verified

Oct 2018

Primary completion

Sep 20, 2016

Completion

Sep 14, 2017

Study Design

Enrollment

11 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Resectable, Low Risk
  Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.
• Experimental: Locally Advanced
  Systemic chemotherapy followed by chemoradiation, followed by definitive surgery

Primary Outcome Measure

Relapse Free Survival [ Time Frame: 1 yr form onset of treatment ]

Locations (1)

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