RTOG 99-15/SWOG S9927), Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women with One to Three Positive Axillary Nodes
RTOG Study Chair: Eric Strom, M.D., (713) 792-3437, FAX (713) 794-5573, estrom@notes.mdacc.tmc.edu
IRB Review Requirements:
(X) Full board review required only for Amendment #2. No review required for Revision 8 and Memorandum
( ) Expedited review allowed
( ) No review required
SWOG’s Amendment #2, Revision #8 and Memorandum are in effect.
In addition, the following forms have been updated:
RTOG 9915, I8 Form, SWOG 9927 Registration Form (Form #1890) and Coding Guidelines
RTOG 9915, I1 Form, S9927 Breast Cancer Prestudy Form (Form #3546) and
RTOG 9915 TX Form, SWOG 9927 Radiotherapy Submission Form (Form #30148)
The following changes (SWOG Amendment #1) are in effect:
AMENDMENT #1
The study referenced above has been revised as follows:
1. The phrase, "+ III" has been inserted after the phrase "Level I and II" in Section 5.2 and in the second sentence of Section 7.4.
2. The beginning of the first sentence of Section 5.4 has been revised to read, "Patients may be registered either prior to, during or immediately after completion of systemic chemotherapy, and . . ." The word "have" has been removed from the parenthetical sentence in this section. Also, the word "tamoxifen" has been replaced with the phrase "hormonal therapy" in the last sentence.
3. In the schema on page 2 and the schema in the model informed consent under "What Is Involved In This Study?", the following changes have been made.
a. The phrase "+ III" has been inserted after the phrase "Level I and II" to be consistent with the changes made in Section 5.2.
b. The parenthetical phrase, "(prior to registration)" has been removed next to the phrase, "Chemotherapy* per institution" and the word "Tamoxifen" has been replaced with the phrase, "Chemotherapy and/or hormonal therapy" in the "*" footnote to be consistent with the changes made in Section 5.4.
4. Section 5.10 has been revised to read, "Patients must be seen in consultation by a Radiation Oncologist prior to registration." The blank for "Group Affiliation" has been removed from this section.
5. A new 3rd sentence has been inserted into Section 7.5d.4 to provide additional radiation therapy information. Also, the phrase "due to concerns of pneumonitis" has been inserted into the last sentence of this section.
6. The phrase, "to treat the chest wall" has been inserted at the end of the last sentence in Section 7.16b.
7. The sentence "Week 1 is the first week of radiation therapy, not necessarily the first week after randomization." has been added to the "¥" footnote in the Study Calendar, Section 9.0.
8. A new first paragraph has been inserted into Section 11.2 regarding a short-term interim analysis after randomization of the first 150 patients in order to verify that patients have received their assigned treatment.
9. The phrase "radiation" has been inserted into the phrase, "complete the treatment" in the first sentence of the first paragraph under "How Long Will I Be In The Study?" The word "that" has been replaced with the phrase, "the radiation therapy" in the second sentence of this paragraph for clarification. A new third sentence has been added to this paragraph to clarify that if the patient should have recurrence of cancer during follow-up for this study, their doctor will discuss different treatment options with them at that time.
10. The S 9 9 2 7 Prestudy Form (Form #26989) has been revised to allow for specification of the type of hormonal therapy prescribed, if it is prescribed. Form #26989 should be replaced with the new form (Form #23957) dated 9/15/2001. The form number for the new S 9 9 2 7 Prestudy Form has been updated in Sections 14.4a and 18.2b.
This amendment requires IRB approval; documentation of approval must be received at RTOG (from RTOG members) prior to study entry.
#1
SUMMARY OF CHANGES
RTOG 99-15 Breast (SWOG 9927)
August 17, 2001
The following changes (SWOG Revisions #1, 2, 3 and 4) are in effect:
REVISION #1
The above-noted study has been revised as specified below:
1. The phrase "be women with" replaces the phrase, "have" in the first sentence of Section 5.1.
2. Section 5.4 has been reworded to provide more time between registration and the beginning of therapy. Specifically, the first sentence has been revised to say, "Patients must be registered after completion of systemic chemotherapy, and radiation therapy should be planned to begin within 6 weeks after completing chemotherpay for breast cancer." A new second sentence has been inserted which states, "The last day of chemotherapy is considered to be the last day that the patient received drug." The parenthetical statement previously in the first sentence is now the third sentence in this section. Also the second parenthetical phrase regarding beginning radiation therapy within 15 working days after registration has been deleted.
3. A new Section 5.7 has been inserted to require that patients must be at least 21 years of age prior to being registered on this study. The rest of the section has been renumbered accordingly.
4. The first sentence of the old Section 5.9 (now Section 5.10) has been reworded to state, "Patients must have been seen in consultation by a Radiation Oncologist from an RT facility approved by one of the participating cooperative research groups prior to registration:"
5. The second sentence of the third paragraph of Section 7.0 requiring radiation therapy to begin within 15 working days after registration has been deleted.
6. The phrase, "randomized to the radiation therapy arm" has been inserted after the phrase, "for all patients" in the first sentence of Section 7.2
7. A new column has been inserted into the study calendar, Section 9.0 titled, "Pre-treat". The "X" and "£" footnote for CT scan of the chest has been moved from the prestudy column to this new column. The end of the sentence which states, "and every two weeks for six weeks for patients on observation" has been removed from the "f" footnote. The first sentence in the "£" footnote has been reworded to state, "CT scans are required for all patients randomized to the RT arm". The parenthetical phrase, "(which may be after registration)" has been removed from the end of the second sentence in this footnote and a third sentence which state, "CT scans are not required for patients randomized to observation." has been added.
8. Section 13.1 has been updated to include the new standards for Southwest Oncology Group registration instructions. A new Section 13.2 has been inserted with the current Southwest Oncology Group - specific registration instructions. Registration instructions for the other participating groups have been numbered as Sections 13.3 - 13.7. The hours for NCCTG registration have been changed from "8:00 a.m. to 5:00 p.m." to "8:00 a.m. to 4:30 p.m." The parenthetical phrase, "(no more than fifteen working days prior to planned start of treatment)" has been removed from the last paragraph of the NCCTG, RTOG and ACOSOG registration instructions. The same parenthetical phrase has been removed from the second to the last paragraph of the ECOG registration instructions.
9. The previous Sections 13.2 - 13.4 have been deleted.
10. The address and phone number for the Southwest Oncology Group Breast Cancer Bank has been updated in Section 15.2. Additionally, the fax number has been added.
11. A new explanatory paragraph has been added to Section 15.3 and the title, "Pathology Coordinator" has been added to the address in this section.
12. Section 15.6 has been revised to include updated ECOG Block Submission instructions.
13. A new AE reporting section for ECOG institutions has been inserted into Section 16.0.
14. The sentence, "They would also like to use the tissue to find out about other cancers or other diseases." has been added to the second paragraph under the "Why is This Study Being Done?" section of the Model Informed Consent.
15. The phrase, "(Radiation Oncology)" has been added after "Laurence Marks, M.D." on the title page.
REVISION #2
The above-noted study has been revised as specified below:
1. Dr. James Hayman replaces Dr. Peter Possert as the secondary contact physician in the Schema and in Sections 7.0 and 8.4.
2. The Southwest Oncology Group Web Reg e-mail address has been updated in Section 13.2a. Also, Section 13.5 has been updated to reflect current ACOSOG registration instructions.
3. Section 14.3d has been updated to reflect current ACOSOG data submission instructions.
4. The phrase, "version 2.X" has been replaced with "version 2.0" in the last paragraph of the Ethical and Regulatory Considerations in Section 16.0. Also, the Guidelines for Reporting of Adverse Events (AE) have been updated to the current Southwest Oncology Group standard language and AE reporting guidelines for the ACOSOG have been inserted at the end of the section.
5. The Southwest Oncology Group Registration Form Code Sheet has been revised to include a code number for ACOSOG. This sheet is included on the back of the S 9 9 2 7 Registration Form (Form #30602). (The S 9 9 2 7 Registration Form [Form #30802] has not been revised.)
REVISION #3
The above-noted study has been revised to correct an error in Revision #2, dated April 15, 2001. In that revision memorandum, it stated that AE reporting instructions for the ACOSOG were inserted into Section 16.0. However, the appropriate page (page 33) was missing from the revision.
REVISION #4
ECOG and CALGB Institutions participating on Southwest Oncology Group-coordinated studies will now submit data directly to the Southwest Oncology Group Statistical Center rather than routing it through either the ECOG Coordinating Center or the CALGB Data Management Center. Data submission instructions for ECOG and CALGB Institutions have been revised as specified below.
ECOG and CALGB data submission instructions have been updated in Sections 14.3e and 14.3f.
MEMORANDUM
The above-noted study, S 9 9 2 7, is a Southwest Oncology Group-coordinated Intergroup Phase III study which randomizes post-mastectomy, pre- and post-menopausal women with Stage II breast cancer and 1 - 3 positive nodes to either receive radiation therapy or to no radiation therapy following mastectomy and adjuvant chemotherapy. This study is vitally important in answering the question of the value of radiation therapy in this cohort of patients.
Per protocol guidelines, patients are registered and randomized following completion of chemotherapy. This timeframe, rather than earlier in the course of treatment, was chosen to minimize the time period during which patients could change their minds and not undergo the option to which they were randomized (I.e., radiotherapy versus observation). However, it is always important to discuss with patients the proposed overall treatment plan early in their therapy. Therefore, we suggest that investigators introduce the concept of this trial, including the arms of randomization, and review the consent form early in the course of treatment with potential candidates for the study. This way when patients are registered and randomized, they are familiar with the trial. This will provide patients with a better understanding of their potential treatment course and help accrual to the study.
Please contact Dr. Lori Pierce, Southwest Oncology Group S 9 9 2 7 Study Coordinator, with any questions regarding this study. Thank you for your support and participation in this trial.