Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic Cancer

NCT02416609 | Unknown

• 1 other identifier: BMed1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).

Conditions

Pancreatic Cancer

Keywords

Locally advanced pancreatic cancer; Stereotactic Body Radiotherapy; Chemopotentiator; Low dose radiotherapy; Hyper-Radiosensitivity

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1

  1 year

Secondary Outcomes (2)

• Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))

  every 3 months, up to 1 year

• Overall survival

  1 year

Study Arms (1)

Gem-based doublets with LDR & sequential SBRT

EXPERIMENTAL

Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.

Radiation: LDR; Drug: Gem-based doublets; Radiation: SBRT

Interventions

LDR RADIATION

LDR will be delivered during each cycle of Gem-based doublets

Also known as: Low dose radiotherapy

Gem-based doublets with LDR & sequential SBRT

Gem-based doublets DRUG

4 cycles of Gem-based doublets

Gem-based doublets with LDR & sequential SBRT

SBRT RADIATION

SBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered

Also known as: Steretactic body radiotherapy

Gem-based doublets with LDR & sequential SBRT

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed adenocarcinoma of the pancreas
• Patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial CT imaging but were found unresectable at surgery
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Age ≥ 18
• Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting treatment
• Patients with radiographically assessable disease
• Adequate bone marrow, hepatic and renal function: -Hemoglobin \>10.0 g/dL, absolute neutrophil count \> 1.5 x 10\^9/L, platelet count \> 100 x 10\^9/L. -Aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 x upper limit of normal (ULN). -Total bilirubin \< 2 mg/dL. Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should decrease to \< 2 mg/dL prior to study entry. - Creatinine \< 3 mg/dL or Creatinine clearance \> 40 mL/min (calculated according to Cockroft and Gault)

You may not qualify if:

• Evidence of metastatic disease in the major viscera or peritoneal seeding or ascites
• Gastric or duodenal obstruction
• Previous peripheral neuropathy
• Previous irradiation to the planned field; previous chemotherapy for pancreatic cancer
• Malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, MO, 41121, Italy

RECRUITING

Related Publications (4)

• Mantini G, Valentini V, Meduri B, Margaritora S, Balducci M, Micciche F, Nardone L, De Rose F, Cesario A, Larici AR, Maggi F, Calcagni ML, Granone P. Low-dose radiotherapy as a chemo-potentiator of a chemotherapy regimen with pemetrexed for recurrent non-small-cell lung cancer: a prospective phase II study. Radiother Oncol. 2012 Nov;105(2):161-6. doi: 10.1016/j.radonc.2012.09.006. Epub 2012 Oct 12.

  PMID: 23068709 BACKGROUND

• Regine WF, Hanna N, Garofalo MC, Doyle A, Arnold S, Kataria R, Sims J, Tan M, Mohiuddin M. Low-dose radiotherapy as a chemopotentiator of gemcitabine in tumors of the pancreas or small bowel: a phase I study exploring a new treatment paradigm. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):172-7. doi: 10.1016/j.ijrobp.2006.11.045. Epub 2007 Feb 2.

  PMID: 17276612 BACKGROUND

• Mahadevan A, Jain S, Goldstein M, Miksad R, Pleskow D, Sawhney M, Brennan D, Callery M, Vollmer C. Stereotactic body radiotherapy and gemcitabine for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):735-42. doi: 10.1016/j.ijrobp.2009.08.046. Epub 2010 Feb 18.

  PMID: 20171803 BACKGROUND

• Valentini V, Massaccesi M, Balducci M, Mantini G, Micciche F, Mattiucci GC, Dinapoli N, Meduri B, D'Agostino GR, Salvi G, Nardone L. Low-dose hyperradiosensitivity: is there a place for future investigation in clinical settings? Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):535-9. doi: 10.1016/j.ijrobp.2009.02.075. Epub 2009 Jun 18.

  PMID: 19540061 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiotherapy

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

Study Officials

• Bruno Meduri, MD

  Azienda Ospedaliero-Universitaria Policlinico di Modena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Meduri, MD

CONTACT

+393388878319; brunomeduri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: January 1, 2014
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

IT (1)