Patient and Investigator Letters

May 29, 2014
MEMORANDUM
TO:
Investigators with Patients Registered to S0518
FROM:
RE:
Charles D. Blanke, M.D.
S0518 Patient Information
Enclosed please find an "Investigator Letter" and a "Patient Information Letter" indicating
the results of the recent SWOG Data and Safety Monitoring Committee recommendation.
This letter includes suggestions for informing the patients of the results of this study and
a list of patients being followed at your institution who are last known to be alive and their
unblinded treatment assignment.
We are asking you to do the following:
1.
Acknowledge receipt of this information, submit the information to your IRB, and
acknowledge your understanding of the actions you must take (listed below) by
signing below and FAXing this letter back to the Operations Office (ATTN: Lisa
Headlee, 210/614-0006). Only a single acknowledgement per institution is
necessary.
I have submitted this information to my IRB.
(Investigator Signature)
(Print Name)
(Print Institution Name)
2.
Read the Investigator Letter.
3.
Inform all patients entered through your institution on this study of their unblinded
treatment assignment and the information in the Patient Letter in the manner
approved by your IRB.
PC/kfk
Enclosures
cc:
Michael LeBlanc, Ph.D.
Katherine A. Guthrie, Ph.D.
Shannon McDonough, M.S.
Cathryn Rankin, M.S.
Stephanie Edwards
Christine McLeod
Rodney Sutter
Lam Le – CTSU
NCI Coop Genentech
Nathan Eriksen
Dana B. Sparks, M.A.T.
Elaine Armstrong, M.S.
Lisa Headlee
May 29, 2014
TO:
Participating Investigators, S0518
FROM:
James C. Yao, M.D. – Study Chair
Howard S. Hochster, M.D. – Gastrointestinal Committee Chair
Christopher W. Ryan, M.D. – Executive Officer
Charles D. Blanke, M.D. – Group Chair
Re:
S0518, “Phase III Prospective Randomized Comparison of Depot Octreotide
Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC
#704865) in Advanced, Poor Prognosis Carcinoid Patients.”
Investigator Letter
On May 2, 2014, the SWOG Data and Safety Monitoring Committee (DSMC) reviewed a
formal interim analysis of S0518 and based on compelling null findings which ruled out
the pre-specified treatment benefit with high confidence, they recommended the primary
treatment comparison results be reported now instead of waiting the additional year
specified in the protocol. There has been no new safety concern regarding
bevacizumab or interferon. The DSMC just found that there was no significant
difference between bevacizumab and interferon in their effects on PFS. Patients
who remain on study treatment may continue therapy as per protocol if the treating
physician feels that the patient is benefiting from study therapy and the patient agrees to
continue the current therapy as a medical intervention after full discussion of this
information with their treating physician.
We are sending this memorandum to SWOG and other Group investigators to notify them
of the DSMC findings and recommended actions.
A “Patient Information Letter” is enclosed to be provided to patients to explain that the
study is ending because the primary research question has been answered.
This information must be provided to patients who are still on study and being followed
per protocol. Documentation that this information was provided must be stored in the
patient’s study record on site and will be subject to verification at the time of a Quality
Assurance audit.
Continued follow up and reporting of adverse events, progression and survival is
important to all subsequent analyses of this trial. Therefore, we would like to exhort all
investigators to continue to submit follow up forms on this trial. We also request that any
outstanding forms be completed and submitted as soon as possible.
We realize that there may be questions and/or concerns about these recommendations.
Please contact Dr. James C. Yao at 713/792-2828 or [email protected] or Dr.
Christopher Ryan at 503/494-8487 to seek any clarification or further details. Thank you
for your patience and understanding in implementing these important actions.
PATIENT INFORMATION LETTER
for
S0518, “Phase III Prospective Randomized Comparison of Depot Octreotide Plus
Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in
Advanced, Poor Prognosis Carcinoid Patients.”
You chose to take part in a Southwest Oncology Group (SWOG) research study for
advanced carcinoid tumor. When you made this choice, the doctors in charge of the
study told you that you would be given any new details that might affect this choice.
SWOG wants to provide you with new information regarding this study now.
You may recall that you were given the chance to help us to test whether treatment with
the drug bevacizumab combined with octreotide might improve outcome for patients with
advanced carcinoid tumor as compared to treatment with interferon combined with
octreotide.
The study’s Data and Safety Monitoring Committee (DSMC) has now determined
that treatment with bevacizumab combined with octreotide does not improve
outcomes for patients with advanced carcinoid tumor as compared to treatment
with interferon combined with octreotide.
The DSMC of SWOG tracks the safety of our studies and regularly reviews study data. If
they see that a treatment may cause harm or may not work, they will suggest that the
Group leaders make changes to the study or end the study early. The DSMC has not
found any new safety concerns regarding bevacizumab or interferon. They just
found that there were no significant differences in carcinoid tumor growth between
patients treated with bevacizumab and octreotide compared with those treated
with interferon and octreotide.
New patient entry into the study stopped September 1, 2012. Most study patients are no
longer taking the study medication. If you are one of the few who are still taking the study
medication, you may either continue your current treatment after discussion of this
information with your doctor or stop and pursue other treatment options based on
discussion with your doctor.
We are giving you this information independent of whether or not you are still getting
study treatment to keep you up to date with the study’s progress. Patients like you who
take part in research studies have contributed enormously to improving cancer treatment,
and your well-being is the main focus of these studies. We will stay in touch with all the
patients on this study.
You should discuss any questions you may have about this Patient Information Letter
with your study doctor. We value the trust you have put in SWOG and regret any
concern this may raise for you. The results from this trial will contribute to the knowledge
of how best to treat patients with advanced carcinoid tumor.
Sincerely,
Charles D. Blanke, M.D.
Chair, SWOG

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