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Geoff Porter, M.D., Chair
CLOSED STUDIES
RTOG 0129 (head & neck) has completed accrual. This was a phase III locally advanced head and neck study where surgery is not an intrinsic component. The study chair and statistician do not feel a surgical quality control review is required (was not described in study protocol).
RTOG 0012 (rectal) has been published. A preliminary surgical quality control review was done by the surgical PI (Dr. Hanna) and forwarded in an Excel file format to RTOG headquarters. The actual review with the forms has not been received by RTOG. Dr. Henna is currently searching boxes from a recent office move for the reviews.
Action item: If Dr. Hanna is unable to find the reviews, RTOG headquarters will resend the review forms for him to complete. Dr. Porter will liaise with Kathryn Winter regarding this issue.
OPEN STUDIES
All studies undergoing current surgical quality control review were reviewed. The list is found on the agenda. Specific issues discussed were the somewhat low compliance (75%) in RTOG 0244 (Head and Neck), a phase II salivary gland transfer study prior to radiotherapy.
Action item: Dr. Porter will communicate with Dr. Seikely to determine the actual compliance issues regarding this trial, and what potential corrective actions need to be taken.
In addition, RTOG 0246 (esophagus) was discussed. This is a phase 2 trial of induction chemotherapy followed by chemoradiotherapy, followed by surgical salvage. It has completed accrual. It was the consensus of the committee, given surgical salvage is an important aspect of the study, it does require a quality control review.
Action item: The decision of the surgical quality control committee will be communicated with headquarters.
RTOG 0247 (rectal) Over 40 cases have been with the surgical PI since 04/06. Delays in returning the review will be discussed in Other Business.
Studies in the Development with Surgical Quality Control Issues
Five studies reviewed by the committee Chair were discussed. Of these, two will require full surgical quality control review including trials RTOG 0618 (lung) and 0619 (head & neck).
OTHER BUSINESS
Timeliness of reviews
Although most reviews are completed in a timely fashion, it is felt a process to ensure this is optimized should be in place. A discussion occurred at the RTOG Quality Control Committee the day previous, and it was felt the coordination of surgery and medical oncology approach to this would be appropriate.
The Surgical Quality Control Committee suggests when reviews are sent out to the surgical study co-chair, an accompanying letter indicates the reviews are due back at headquarters within two months. If they are not received within two months, a second letter requesting the reviews within one-month deadline will be sent to the surgical study co-chair, with a copy to the Study Chair. If the reviews are not received within a month, the Study Chair as well as the Disease Site Chair will receive a letter requesting resolution to the issue.
Action Item: Dr. Porter will liaise with Kathryn Winter to establish this process.
Surgery within RTOG trials
Discussion ensued around the apparent decrease in "surgery intrinsic" trials within RTOG. Although the overall number of trials undergoing surgical quality control review has remained stable over the past four years, the number of trials with surgery as an/the intrinsic component to the trial has decreased. This topic was discussed at a recent surgical committee conference call of the RTOG Surgery Committee; several strategies were proposed to the RTOG leadership. The Surgical Quality Control Committee felt there might be an opportunity, within a developing specific trial, to highlight surgical quality control. These would likely require coordination with pathology.
Action item: Dr. Porter will liaise with the surgical site chairs to determine whether any trials in the development phase and would be suitable for this type of approach. He will also discuss this further with Dr. Peter Pisters.
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Geoff Porter, M.D. Chair
- Reviews Performed
The overall compliance over the past 12 months falls within the typical historical range; the inevaluable rate was 7%. Dr. Porter reported the number of surgical QC reviews performed over the past 6 months was low, although the number of trials with surgical QC requirement remains steady at ten.
- Current Protocols and Ongoing Reviews
All current protocols undergoing surgical quality control were reviewed. No significant issues were noted, with the exception of a 33% (3/9) deviation rate in RTOG 0244 (Head and Neck)
Action Item: Dr. Porter will liaise with the surgical study Chair, Dr Seikeley, to get further information regarding these deviations, and the need for any further surgical QC involvement.
It was noted RTOG 0330 (sarcoma) will likely close soon due to low accrual.
RTOG 0412, 0552, and 0246 are undergoing S4 form development. The Head and Neck team is examining the need for review of RTOG 0129.
- Studies in the pipeline
Dr. Porter has reviewed eight proposals in the development phase over the past 12 months. As a result of this process, substantive revisions aimed at optimizing surgical QC occurred for the following protocols:
- RTOG 0417 (Gynecology)
- RTOG 0529 (GI)
- RTOG 0526 (Genitourinary)
- RTOG 0618 (Lung)
- RTOG 0435 (Head and Neck)
Surgical QC review will be required for each of these studies
- Other Business
In March 2006, a meeting of surgical representatives of NCI-sponsored cooperative groups took place in San Diego. This meeting, organized by Dr. Meg Mooney (Surgical Head at NCI) with RTOG representation by Dr. Peter Pisters (Vice-Chair, Surgery) and Dr. Geoff Porter (Chair, Surgical Quality Control), included significant discussion around surgical quality control/assurance. Specifically, the potential for surgical standardization across cooperative groups (e.g., disease-based standardized S-1 forms and definitions) was explored. There appeared to be significant interest from most cooperative group representatives. The RTOG Surgical Quality Control Committee strongly supports, and wishes to participate in, continued work in this area.
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Geoff Porter, M.D., Chair
1. Reviews Performed
The overall compliance on reviews was 94.4%, which falls within the typical historical range; the inevaluable rate was 7%. RTOG 9111 (head and neck) completed reviews during the last 6 months. All reviews have been performed for RTOG 0012 (rectal), although these have not been included in the last 6-month report.
2. Current Protocols and Ongoing Reviews
All current protocols undergoing surgical quality control were reviewed. No significant issues were noted.
Other studies currently open include RTOG 0129 (Head & Neck), 0132 (Sarcoma), RTOG 0244 (Head & Neck), 0142 (Lung). Of these, the review form is being finalized for RTOG 0132. It has been noted there has been low accrual to RTOG 0244.
Four other studies which have all been opened in the past year do require surgical quality control review. These include RTOG 0247 (Rectal), RTOG 0234 (Head & Neck), RTOG 0229 (Lung), and RTOG 0330 (Sarcoma).
Action item: Stephen Dorian will check to ensure reviews are proceeding with these four studies, and they are included in the report in six months.
3. Studies in the Pipeline
Dr. Porter has reviewed three proposals in the development phase over the past six months; none of these studies have any surgical QC issues, or require review. RTOG 0435 is a Head & Neck study looking at the use of Palifermin in reducing
4. Other Business
A preliminary meeting to examine surgical QC issues across cooperative groups will occur in the next few months, probably at the Society of Surgical Oncology meeting in March. This will be organized by NCI (Meg Mooney and Ted Trimble), and CTEP (Jeff Abrams).
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Geoff Porter, M.D., Chair
The committee met to review ongoing protocols and discuss new protocols as they have been activated. In addition, several additional items were discussed.
Studies Closed
RTOG 8911
Current Studies
Current studies undergoing surgical review include two head and neck studies (RTOG 9111 and RTOG 9501), thoracic study RTOG 9309, and a GI study RTOG 9704. Reviews for these are going well. In addition, review forms are being drafted, or have been drafted, for RTOG 9904, 0024, and 0012. For the two sarcoma studies, 0124 and 0132, the review form is in the draft stages.
Review Required?
1. RTOG 9905 - (Endometrium). This study simply requires hysterectomy as entry criteria and will not require surgical review.
2. RTOG 9909 - (Lung). This Phase II study are for patients following resection with stage II or IIIa lung cancer with only hilar N1 disease or N2 disease likely should have surgical review to fully assess the eligibility as determined by surgery and pathology. Specifically, the issue of peri-broncheal versus hilar node probably should be reviewed.
Action Item: Dr. Porter will contact Dr. David Johnstone to further discuss review of this study.
3. RTOG 0233 (Bladder). This Phase III study involves post chemotherapy transurethral bladder biopsy with salvage cystectomy used for patients with ³ T1 disease. Discussion ensued regarding previous approach to surgical review of diagnostic/staging surgical biopsies..
Action Item: Dr. Porter will talk to Dr. Uzo and the study statistician regarding the appropriateness of review.
Management of Non-English Documentation for Surgical Review
JoAnn Stetz outlined that recently there has been some reluctance by institutions to fully translate surgical and pathology reports for study and review purposes. In almost all of these cases, it dealt with French documents. After some discussion, it was felt that perhaps the best approach would be, in studies where a significant contribution by French-speaking hospitals was expected, that a second surgical reviewer fluent in French be assigned to the study. The surgical lead for the study would identify such an individual. The RTOG headquarters research associate should be able to identify such studies and approach the appropriate lead for the study in this regard. It is hoped that this will obviate the need for significant expense and time spent in translating operative and pathology reports.
New Studies
It is felt by the committee that, for certain studies, it may be beneficial for the Surgical Quality Control Committee to be involved in the study development and draft phase. As an example, the upcoming salivary gland transfer study will likely involve significant surgical quality control issues. Involvement of the Surgical Quality Control Committee and/or the Chair prior to the study activation phase may be preferable.
Action Item: Dr. Porter will discuss this further with Steve King and Dr. Pisters. It is hoped that some sort of a mechanism can be in place that for studies with a significant surgical component, or where quality control of surgery is critical, or that communication between the surgical lead and the Chair or the Surgical Quality Control Committee can clarify the approach to the Surgical Quality Control for the given trial.
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Peter W.T. Pisters, M.D., Chair
The Committee met to review ongoing protocols and to discuss protocols that are not being reviewed in an adequate and timely fashion. Overall, there are no major problems related to current surgical reviews. Reviews have been completed in a timely fashion according to schedule.
Studies closed: Protocols 9401, 9612, and 9613 have been closed for accrual reasons. Surgical review will therefore not be necessary for these protocols.
Current protocols: Studies requiring surgical review include 8911, 9111, 9309, 9501, 9514, 9517, 9704, and 9705. These were sequentially discussed without any specific identified deficiencies in surgical review. There is still ongoing concern regarding protocol 9517 (J. Bolton, M.D., Surgical Study Chair) for which no reviews have been completed to date. Dr. Bolton will be contacted regarding the status of surgical reviews for this protocol.
Studies with optional surgical review: Protocols 9811 and 9812 which do not include surgery as part of the protocol treatment plan will be eliminated from the ongoing list of studies requiring surgical review.
In attendance: Peter W.T. Pisters (M. D. Anderson Cancer Center), Robert Ginsberg (Memorial Sloan-Kettering Cancer Center), David Johnstone (Rochester, New York), Charles Levenback (M. D. Anderson Cancer Center), Victor Lawson (The University of Kentucky), JoAnn Stetz (RTOG Headquarters), Karen Kuhn (RTOG Headquarters), Bryan Berkey (RTOG Headquarters), Janet Finnegan (RTOG Headquarters), and Barbara Kaiser (RTOG Headquarters).
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Elin Sigurdson, M.D., Chair
The committee met to review ongoing protocols and discuss issues of protocols, that are not being reviewed in an adequate and timely fashion. There has been a significant improvement since the last meeting with some of the significant protocols under review being taken on by new individuals who have agreed to do chart reviews in Philadelphia. Most notably Dr. Johnstone has taken over the RTOG 97-05 lung protocol and will review all surgical cases in the next month. The other thoracic and head and neck protocols have been reviewed in a timely manner and are now near completion. The sarcoma protocol, which is nearing completion, will be reviewed by Drs. Kraybill and Eisenberg in their meeting this week to finalize these forms.
New protocols including anal canal, gastric and pancreatic studies have assigned reviewers and forms are in development or finalized at this point.
We have again reiterated our concerns that surgical review forms need to be in place when the protocol opens and this has been expressed to the Quality Control Committee and to the headquarters where it is being made part of the bylaws.
The committee was also concerned that the surgical review forms and pathology forms be standardized. To this and the American Society of Colorectal Surgeons as well as surgical representatives of the groups are meeting at the NCI this spring to standardize forms for colorectal and anal cancers. If this meeting is successful then the other groups have been asked to approach the NCI to prepare forms for their groups.
David Johnstone and Robert Ginsberg have considerable expertise in setting up thoracic forms and John Jacobs, Bruce Campbell and Don Sessions will review head and neck forms and will prepare standardize forms.
Finally, a request was made for funding to bring individuals to Philadelphia to make final reviews where a significant number of charts must be reviewed in order to facilitate speed and accuracy of these reviews. This includes RTOG 95-01 head and neck protocol, RTOG 97-05 a lung protocol and RTOG 95-14 a sarcoma protocol. For these people the reviewers of these protocols travel funds have been requested to Headquarters to support the reviews before the next meeting.
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