Evaluation of the Efficacy and Safety of Neoadjuvant Therapy in Patients With Surgically Resectable Pancreatic Adenocarcinoma.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris

About this trial

This is an open master platform trial, which includes multi neo-adjuvant treatment trials, multi-center, national. This platform trial evaluates the major pathological response rate (mPR) after surgery.

Intervention: The procedure consists of administering a neoadjuvant treatment and then performing pancreatic surgery. The POWER platform trial aims to study several neoadjuvant treatments prior to surgery. They will be described in each sub-study, in appendix. The surgery will be performed on one day and the end of the treatment is the safety visit post-surgery (90 days after surgery).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult, age ≥ 18 years old at the time of signing the informed consent form.

Documented informed consent.

Histologically or cytologically confirmed pancreatic adenocarcinoma.

Tumor deemed resectable based on local assessment.

Disqualifiers

Ongoing participation in clinical sub-study involving the use of an investigational product prior to registration in the sub-study.

During participation in this study, patients will not receive any other clinical investigational drugs or any other anti-tumor drugs as describes on sub-study.

Previous neoadjuvant or induction treatment for pancreatic cancer, including cytotoxic chemotherapy, immunotherapy, experimental therapy, or radiotherapy.

Uncontrolled tumor-related pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GnP

    Drug

    POWER B - Neo adjuvant treatment (GnP) for 28 days

  • FOLFIRINOX

    Drug

    POWER A - Neo adjuvant treatment (Folfirinox) for 28 days

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: POWER A - FolfirinoxExperimental treatment 1 intervention
Group B: POWER B - GnPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major pathological response rate (mPR) on surgical resection specimen

The efficacy of various experimental drugs, based on pathological response, when administered in a preoperative setting will be analyzed. The major pathological response rate (mPR) will be evaluated on the surgical resection specimen

Time frame
After pancreatic surgical resection, after 28 days of treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: