Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 03, 2015 FBO #4878
DOCUMENT

A -- Prospective Randomized Phase 3 Trial of Carbon Ion versus Conventional Radiation Therapy for Locally, Advanced, Unresectable Pancreatic Cancer - Package #1

Notice Date

4/1/2015
 

Notice Type

Package #1
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
 

ZIP Code

20852
 

Solicitation Number

BAA-N01CM51007-51
 

Point of Contact

Corwin Stephens, Phone: 240-276-5362, MaryAnne Golling, Phone: 240-276-6981
 

E-Mail Address

corwin.stephens@nih.gov, gollingm@mail.nih.gov
(corwin.stephens@nih.gov, gollingm@mail.nih.gov)
 

Small Business Set-Aside

N/A
 

Description

PRE-SOLICITATION NOTICE THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. I. INTRODUCTION The Radiation Research Program (RRP) is responsible for the National Cancer Institute's (NCI) clinically-related extramural radiation research program. As part of ongoing efforts to stimulate research in radiotherapy and radiation biology, the RRP supports basic, translational, and clinical research in the Division of Cancer Treatment and Diagnosis (DCTD) by: - Providing expertise to investigators and potential grantees who perform cutting-edge research with radiation and other forms of energy - Helping to lead the radiotherapy research community in establishing priorities for the future direction of radiation research, including interagency cooperation and collaboration - Developing and promoting collaborative efforts among extramural investigators for both preclinical and clinical investigations -Creating unique models and capabilities to help and mentor medically underserved communities in the United States and worldwide to access cancer clinical trials -Evaluating the effectiveness of radiation research being conducted by NCI grantees -Advising the NCI-funded clinical trials groups and the Cancer Therapy Evaluation Program (CTEP) regarding scientific priorities and quality assurance in clinical studies with radiotherapy -Through the Molecular Radiation Therapeutics Branch, providing guidance to extramural investigators, collaborating with DCTD experts and working with colleagues in the Frederick National Laboratory for Cancer Research to develop novel combined modality therapy -Serving as the NCI's liaison and advisor on the mitigation of radiation injury to normal tissue and the development of biomarkers for radiation injury in programs addressing radiological and nuclear terrorism in the National Institute of Allergy and Infectious Diseases (NIAID) and the Office of the Assistant Secretary for Preparedness and Response within the Department of Health and Human Services. II. DESCRIPTION Radiotherapy is an important part of the treatment of unresectable pancreatic cancer. Although older trials were inconsistent, a recent ECOG Phase 3 trial showed a survival advantage to the combination of radiotherapy and gemcitabine over gemcitabine alone (Loehrer 2011). The study was closed early because of slow accrual; however, in the 74 patients enrolled, median survival improved from 9.2 to 11.1 months (p=0.017). These results, together with the recent recognition that uncontrolled local growth is the cause of death in 30% of patients (Iacobuzio-Donahue et al., 2009) lend support to the notion that survival may be improved in some patients with unresectable pancreatic cancer through intensification of local therapy. Recently, The National Institute of Radiological Sciences (NIRS) reported that after carbon ion radiotherapy (CIRT) plus chemotherapy of locally advanced pancreatic cancer the 2-year survival rate was 54%. This data was reviewed during visits to NIRS by investigators from the Mayo Clinic and the gastrointestinal committee of NRG and found to be credible. The data indicates that CIRT can be delivered safely and results in encouraging local control rates. Furthermore, it strongly suggests that survival can be extended in some patients with unresectable pancreatic cancer through improvement in local control and prevention or delay of local complications, which lead to death. III. OBJECTIVE The National Cancer Institute (NCI) intends to solicit proposals for a contractor to conduct a clinical trial for A Prospective Randomized Trial of Carbon Ion versus Conventional Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer. The goal of this contract will be the conduct of a randomized Phase 3 trial of carbon ion radiotherapy (CIRT) vs. 3D conformal radiation therapy (3D-CRT) for unresectable pancreatic cancer, and comparison of its outcome with parallel trial, RTOG1201, carried out by NRG Oncology ( http://www.nrgoncology.org/ ), a member organization of the NCI Clinical Trials Network (NCTN, http://www.cancer.gov/clinicaltrials/nctn ). The Contractor shall provide essential clinical trial infrastructure and laboratory support to carry out and assess the outcome of randomized clinical trials according to the specific research protocol developed by the Contractor. The Contractor shall possess the facilities, infrastructure, and access to the required study population in order to perform studies using both 3D-CRT and CIRT. The goals of the program are: 1. To conduct a randomized clinical trial necessary to assess the value of CIRT for unresectable pancreatic cancer as directly compared to 3D-CRT. 2. To enable indirect comparison of this trial outcome to the outcome of the IMRT vs. 3D-CRT trial carried out in the US (RTOG1201). To meet the objectives of this acquisition, the contractor shall: -Set up the infrastructure, with the appropriate number and mix of clinical, laboratory, and support personnel, to conduct a definitive randomized clinical trial comparing 3D-CRT and CIRT as described in the Protocol. - Establish collaboration and maintain very close communication throughout with NRG Oncology in order to ensure comparability of the control (3D-RT arm of the CIRT trial with RTOG1201) and to enable indirect comparisons between the two investigational radiation treatment modalities being studied: IMRT and CIRT - Recruit patients for the clinical trial to assess the potential of CIRT, according to the protocol. - Follow each subject until death or for a minimum of 2 years. - Conduct studies in compliance with Good Clinical Practice (GCP) guidelines and other regulatory requirements governing the safe conduct of research involving human subjects. - Obtain and process biospecimens as described in the protocol. Guidelines to be followed can be found at: http://biospecimens.cancer.gov/bestpractices/2011-NCIBestPractices.pdf It is anticipated the services will be acquired through full and open competitive procedures under NAICS 54712. It is anticipated that a fixed price contract with a base period of of 1 year and 4(four) - one year options may be awarded, not to exceed five (5) years. An award is expected to be made on or about September 30, 2015. NCI estimates that single contract may be issued for a total cost (direct and indirect costs combined) of up to $ 2 million for 5 years. The length of time for which funding is requested should be consistent with the nature and complexity of the proposed research. The contractor must meet the mandatory qualification criteria at the time of receipt of proposal as follows: The offeror must have non-interference use of facilities and equipment for carbon ion radiotherapy. The amount of resources made available under this BAA will depend on the quality of the proposals received and the availability of funds. The Government reserves the right to select for negotiation all, some, one, or none of the proposals received in response to this BAA, and to make awards without discussions, if it is later determined to be necessary. Additionally, the Government reserves the right to accept proposals in their entirety or select only portions of proposals for award. BAA No. N01CM51007-51 will be issued electronically at a later date and may be accessed through FedBizOpps at www.fbo.gov. Proposals will be due approximately 45 days after the issue date of the Broad Agency Agreement (BAA). WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. NOTE: Organizations responding to this BAA must have documented expertise in clinical research and clinical research in the patient population proposed or in the type of study proposed, and demonstrated knowledge of applicable regulatory guidelines.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/BAA-N01CM51007-51/listing.html)
 

Document(s)

Package #1
 

File Name: Joint Meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board - June 2014 (the relevant presentation starts at 2:40) (http://videocast.nih.gov/summary.asp?live=14250&bhcp=1)

Link: http://videocast.nih.gov/summary.asp?live=14250&bhcp=1

 

File Name: RTOG1201 Protocol (http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1201)

Link: http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1201

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03686005-W 20150403/150401235300-f35d5f94d4cfa81af4ace0f953f34ec0 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |