Neoadjuvant Chemotherapy and Stereotactic Radiosurgery to Pancreatectomy for Patients With Borderline Resectable Pancreatic Cancer

NCT03199144 | Withdrawn Phase 2

• 1 other identifier: Pancreas cancer neoadjuvant
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to test if in situations of borderline resectable patients a neoadjuvant treatment combining Gemzar-Abraxane and stereotactic radiosurgery could increase the median OS rates above 30 months that means at least 12 months more than the 18-20 months generally described.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic Neoplasms; Borderline resectable; Neoadjuvant treatment; Chemotherapy; Stereotactic radiation

Outcome Measures

Primary Outcomes (1)

• patient overall survival

  patient overall survival

  follow up during 3 years after patient inclusion

Secondary Outcomes (4)

• positive surgical margins

  follow up during 3 years after patient inclusion

• toxicity according the CTCAEv4

  follow up during 3 years after patient inclusion

• CA19.9 level post operatively

  follow up during 3 years after patient inclusion

• CEA level post operatively at one month

  follow up during 1 month after patient inclusion

Study Arms (1)

Stereotactic radiotherapy

EXPERIMENTAL

Stereotactic radiotherapy delivering 30 Gy in 5 fractions over 9 days

Drug: Chemotherapy; Radiation: Stereotactic radiotherapy; Procedure: Surgery

Interventions

Chemotherapy DRUG

3 cycles of Gemzar-Abraxane

Stereotactic radiotherapy

Stereotactic radiotherapy RADIATION

Stereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days

Stereotactic radiotherapy

Surgery PROCEDURE

Whipple procedure will be the recommended procedure but will be modified according to the initial tumor location

Stereotactic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven pancreatic adenocarcinoma
• Borderline resectable pancreatic adenocarcinoma (NCCN guidelines)
• OMS status ≤2
• Age at presentation \>18 y
• Absolute neutrophil counts \>1500/ml
• Absolute platelet count \>100000/ml
• GOT and GPT \<2.5 x the upper limit of normal
• Total bilirubin \< the upper limit of normal
• Serum creatinin \< upper limit of normal
• Coagulation test within limit of normal (Prothrombin time, INR) +/- 15%
• No evidence of jaundice at enrolment. If stent required to alleviate jaundice it should be metallic
• Patient must be able to eat without a feeding tube and can take medications orally
• Disease must be encompassed in a reasonable radiation field
• Signed informed consent

You may not qualify if:

• Distant metastases
• Evolutive disease after the neoadjuvant chemotherapy course according RECIST criteria
• Neuroendocrine tumors
• Peritoneal dissemination visualized at diagnostic abdominal CT scan
• Pathologic abdominal nodes visualized at diagnostic abdominal CT scan outside the pancreatic area
• Pathologic PET scan outside the pancreatic area
• Inoperability for medical reasons
• Inability to tolerate chemotherapy for medical (in particular grade II or more neuropathy) or allergic purposes, or for OMS score \>2
• Inability to tolerate Whipple resection
• Collagenose diseases
• Cancer evolution outside the pancreatic bed at the PET scanner performed just after the 3 neo adjuvant chemotherapy cycles
• Any previous cancer in the 5 years excepted a basal skin cell carcinoma or in situ cervical cancer
• Active infection with HIV, Hepatitis B or c
• Pregnant patient

Sponsors & Collaborators

• Centre Francois Baclesse, Luxembourg: lead

Study Sites (1)

Centre Francois Baclesse

Esch-sur-Alzette, SUD, L-4240, Luxembourg

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy; Radiosurgery; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 26, 2017
• Study Start: April 20, 2017
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)