2122: Testicular/Germ Cell Cancer Post-HSCT Data

Transcription

1 2122: Testicular/Germ Cell Cancer Post-HSCT Data Registry Use Only Sequence Number: Date Received: Key Fields Sequence Number ELSE GOTO Date Received: Date Received: - - ELSE GOTO CIBMTR Center Number CIBMTR Center Number: ELSE GOTO CIBMTR Recipient ID: ELSE GOTO Today's Date: Today's Date: - - ELSE GOTO Date of HSCT for which this form is being completed: Date of HSCT for which this form is being completed: ELSE GOTO Autologous - - HSCT type (check all that apply): Autologous ELSE GOTO Allogeneic, unrelated Allogeneic, unrelated ELSE GOTO Allogeneic, related Allogeneic, related ELSE GOTO Syngeneic (identical twin) Syngeneic (identical twin) ELSE GOTO Marrow Product type (check all that apply): Marrow ELSE GOTO PBSC PBSC ELSE GOTO Cord blood Cord blood ELSE GOTO Other product CIBMTR Form 2122 revision 2 (page 1 of 10) Last Updated November 12, 2012.

2 Other product IF Other product:= checked THEN GOTO Specify: ELSE GOTO Visit: Specify: ELSE GOTO Visit: Visit: O 100 day O 6 months O 1 year O 2 years O > 2 years, IF Visit::= > 2 years, THEN GOTO Specify: ELSE GOTO (1) best response to HSCT Specify: ELSE GOTO (1) best response to HSCT Disease Assessment at the Time of Best Response to HSCT Questions: 1-3 To be completed in conjunction with a Form Days Post-HSCT Data, Form 2200 Six Months to Two Years Post- HSCT Data, or Form 2300 Yearly Follow-Up for Greater Than Two Years Post-HSCT Data. Information reported here should reflect the date of last contact as reported in the post-hsct data collection form or immediately prior to death. Best response is based on response to the HSCT, but does NOT include response to any therapy given for disease relapse or progression post-hsct. When determining the best response to HSCT, compare the post-hsct disease status to the status immediately prior to the preparative regimen, regardless of time since HSCT. This comparison is meant to capture the BEST disease status in response to HSCT that occurred in the reporting interval, even if a subsequent disease relapse or progression occurred during the same reporting interval. If a recipient already achieved their best response in a previous reporting interval, confirm the best response and check the box to indicate date previously reported. 1 Compared to the disease status prior to the preparative regimen, what was the best response to HSCT since the date of the last report? (Include response to any post-hsct treatment planned as of Day 0.) O continued complete response (CCR) - continued absence of all disease after a complete response to a previous line of therapy O complete response (CR)- absence of clincally detectable disease including normal HCG and AFP and normalization of previously abnormal radiographic studies for at least one month O partial response (PR) - >= 50% reduction in the sum of the perpendicular diameters of measurable lesions for >= 1 month and/or >= 50% reduction in tumor markers O stable disease (SD) - tumor regression not fulfilling the requirement for partial response or tumor progression < 25% increase in the bidimensionally measurable tumor parameters response (NR) - <=50% reduction in disease or tumor markers O progressive disease (PD) - new lesions that prove to be viable cancer and/or rise in the pre-treatment tumor markers and/or > 25% increase in measurable lesions that are related to progressive viable cancer O markers elevated (ME) - no measurable disease, but tumor markers elevated t evaluable, toxic death (NETD) IF (1) best response to HSCT:= not evaluable, toxic death (NETD) THEN GOTO (4) Has the disease relapsed or progressed since the date of the last report? ELSE GOTO (2) date of best response was previously reported 2 date of best response was previously reported IF (2) date of best response was previously reported:= checked THEN GOTO (4) Has the disease relapsed or progressed since the date of the last report? ELSE GOTO Date the best response first began: Date the best response first began: - - ELSE GOTO (3) Was the response documented surgically? CIBMTR Form 2122 revision 2 (page 2 of 10) Last Updated November 12, 2012.

3 3 Was the response documented surgically? ELSE GOTO (4) Has the disease relapsed or progressed since the date of the last report? Relapse or Progression Post-HSCT Questions: Has the disease relapsed or progressed since the date of the last report? IF (4) Has the disease relapsed or progressed since the date of the last report?:= yes THEN GOTO (5) Date of progression/relapse unknown ELSE GOTO (19) planned treatment given since last report 5 Date of progression/relapse unknown IF (5) Date of progression/relapse unknown:= checked THEN GOTO (6) Allogeneic HSCTs only: Was there subsequent disease stability or regression without further therapy (so-called graft-versus-tumor effect)? ELSE GOTO Date of progression / relapse: Date of progression / relapse: - - ELSE GOTO (6) Allogeneic HSCTs only: Was there subsequent disease stability or regression without further therapy (so-called graft-versus-tumor effect)? 6 Allogeneic HSCTs only: Was there subsequent disease stability or regression without further therapy (so-called graftversus-tumor effect)? IF (6) Allogeneic HSCTs only: Was there subsequent disease stability or regression without further therapy (socalled graft-versus-tumor effect)?:= yes THEN GOTO (7) was this a partial response? ELSE GOTO (9) Central nervous system 7 Did this change in disease status qualify as a partial response or better if compared to a post-hsct imaging study? (Partial response is defined as >= 50% reduction in the sum of the perpendicular diameters of measurable leasions for >= 1 month and/or >=50% reduction in tumor markers.) IF (7) was this a partial response?:= no THEN GOTO (9) Central nervous system ELSE GOTO (8) Date unknown 8 Date unknown IF (8) Date unknown:= checked THEN GOTO (9) Central nervous system ELSE GOTO Date of response: Date of response: - - ELSE GOTO (9) Central nervous system CIBMTR Form 2122 revision 2 (page 3 of 10) Last Updated November 12, 2012.

4 Specify site(s) of disease progression / recurrence: 9 Central nervous system ELSE GOTO (10) Liver-parenchymal 10 Liver-parenchymal ELSE GOTO (11) Lung 11 Lung ELSE GOTO (12) Lymph nodes - distant 12 Lymph nodes - distant ELSE GOTO (13) Lymph nodes - regional 13 Lymph nodes - regional ELSE GOTO (14) Pelvis 14 Pelvis ELSE GOTO (15) Pleura 15 Pleura ELSE GOTO (16) Tumor markers (AFP, HCG, LDH) 16 Tumor markers (AFP, HCG, LDH) ELSE GOTO (17) Other site: 17 Other site: IF (17) Other site::= yes THEN GOTO (18) Specify site: ELSE GOTO (19) planned treatment given since last report 18 Specify site: ELSE GOTO (19) planned treatment given since last report CIBMTR Form 2122 revision 2 (page 4 of 10) Last Updated November 12, 2012.

5 Post-HSCT Planned Treatment for Testicular Cancer Questions: Was planned treatment given per protocol since the date of the last report? (Include any maintenance therapy, but exclude any treatment for relapse / progressive disease.) IF (19) planned treatment given since last report:= no THEN GOTO (58) Abdomen - CT ELSE GOTO (20) Was surgical resection performed for persistent radiographic abnormalities? 20 Was surgical resection performed for persistent radiographic abnormalities? IF (20) Was surgical resection performed for persistent radiographic abnormalities?:= no THEN GOTO (26) Was radiation therapy given? ELSE GOTO (21) Specify date of surgery: 21 Specify date of surgery: - - ELSE GOTO (22) Specify type of surgery: 22 Specify type of surgery: O biopsy only (not debulking) O debulking O orchioectomy only O removal of extra-abdominal metastatic lesion O unilateral retroperitoneal lymph node dissection and orchiectomy O other type of surgery, specify IF (22) Specify type of surgery::= other type of surgery, specify THEN GOTO (23) Specify surgery: ELSE GOTO (24) Was the extent of the resection confirmed radiographically? 23 Specify surgery: ELSE GOTO (24) Was the extent of the resection confirmed radiographically? 24 Was the extent of the resection confirmed radiographically? ELSE GOTO (25) Was any persistent, viable tumor detected? 25 Was any persistent, viable tumor detected? ELSE GOTO (26) Was radiation therapy given? 26 Was radiation therapy given? IF (26) Was radiation therapy given?:= no THEN GOTO (36) Was chemotherapy / immunotherapy given? ELSE GOTO (27) Specify date radiation started: 27 Specify date radiation started: - - ELSE GOTO (28) Specify date radiation stopped: 28 Specify date radiation stopped: - - ELSE GOTO (29) Pelvis CIBMTR Form 2122 revision 2 (page 5 of 10) Last Updated November 12, 2012.

6 Specify the radiation field(s): 29 Pelvis IF (29) Pelvis:= no THEN GOTO (31) Total abdomen ELSE GOTO (30) Total dose: 30 Total dose: cgy (rads) ELSE GOTO (31) Total abdomen 31 Total abdomen IF (31) Total abdomen:= no THEN GOTO (33) Other site: ELSE GOTO (32) Total dose: 32 Total dose: cgy (rads) ELSE GOTO (33) Other site: 33 Other site: IF (33) Other site::= no THEN GOTO (36) Was chemotherapy / immunotherapy given? ELSE GOTO (34) Specify field: 34 Specify field: ELSE GOTO (35) Total dose: 35 Total dose: cgy (rads) ELSE GOTO (36) Was chemotherapy / immunotherapy given? 36 Was chemotherapy / immunotherapy given? IF (36) Was chemotherapy / immunotherapy given?:= no THEN GOTO (58) Abdomen - CT ELSE GOTO (37) Specify date therapy started: 37 Specify date therapy started: - - ELSE GOTO (38) Specify date therapy stopped: 38 Specify date therapy stopped: - - ELSE GOTO (39) aldesleukin (interleukin-2) Specify systemic treatment(s): 39 aldesleukin (interleukin-2) ELSE GOTO (40) altretamine (Hexalen) 40 altretamine (Hexalen) ELSE GOTO (41) bleomycin (BLM, Blenoxane) CIBMTR Form 2122 revision 2 (page 6 of 10) Last Updated November 12, 2012.

7 41 bleomycin (BLM, Blenoxane) ELSE GOTO (42) carboplatin (Paraplatin) 42 carboplatin (Paraplatin) ELSE GOTO (43) cisplatin (CDDP, Platinol) 43 cisplatin (CDDP, Platinol) ELSE GOTO (44) cyclophosphamide (CTX) 44 cyclophosphamide (CTX) ELSE GOTO (45) dactinomycin (Cosmegen) 45 dactinomycin (Cosmegen) ELSE GOTO (46) Doxorubicin (Adriamycin) 46 Doxorubicin (Adriamycin) ELSE GOTO (47) Doxorubicin liposomal (Doxil) 47 Doxorubicin liposomal (Doxil) ELSE GOTO (48) Etoposide (VP-16, VePesid) 48 Etoposide (VP-16, VePesid) ELSE GOTO (49) Gemcitabine (Gemzar) 49 Gemcitabine (Gemzar) ELSE GOTO (50) Ifosfamide (Ifex) 50 Ifosfamide (Ifex) ELSE GOTO (51) Mitoxantrone (Novantrone) 51 Mitoxantrone (Novantrone) ELSE GOTO (52) methotrexate (MTX, Folex) 52 methotrexate (MTX, Folex) ELSE GOTO (53) paclitaxel (Taxol) CIBMTR Form 2122 revision 2 (page 7 of 10) Last Updated November 12, 2012.

8 53 paclitaxel (Taxol) ELSE GOTO (54) thiotepa (Thioplex) 54 thiotepa (Thioplex) ELSE GOTO (55) vinblastine (Velban, VLB) 55 vinblastine (Velban, VLB) ELSE GOTO (56) other therapy 56 other therapy IF (56) other therapy:= no THEN GOTO (58) Abdomen - CT ELSE GOTO (57) Specify treatment: 57 Specify treatment: ELSE GOTO (58) Abdomen - CT Most Recent Laboratory Studies Post-HSCT Questions: Specify the results of any imaging studies performed for the following disease sites since the date of the last report: 58 Abdomen - CT t tested ELSE GOTO (59) Bone - bone scan 59 Bone - bone scan t tested ELSE GOTO (60) Bone - CT 60 Bone - CT t tested ELSE GOTO (61) Bone - MRI 61 Bone - MRI t tested ELSE GOTO (62) Bone - x-ray 62 Bone - x-ray t tested ELSE GOTO (63) Chest - CT CIBMTR Form 2122 revision 2 (page 8 of 10) Last Updated November 12, 2012.

9 63 Chest - CT t tested ELSE GOTO (64) Chest - x-ray 64 Chest - x-ray t tested ELSE GOTO (65) Head - CT 65 Head - CT t tested ELSE GOTO (66) Head - MRI 66 Head - MRI t tested ELSE GOTO (67) Pelvis - CT 67 Pelvis - CT t tested ELSE GOTO (68) PET scan 68 PET scan t tested ELSE GOTO (69) Serum alpha-fetoprotein (AFP): Specify the following tumor markers determined since the date of the last report: 69 Serum alpha-fetoprotein (AFP): O known t known IF (69) Serum alpha-fetoprotein (AFP)::= not known THEN GOTO (71) Serum beta-hcg (BHCG): ELSE GOTO (70) AFP value 70 ng/ml ELSE GOTO (71) Serum beta-hcg (BHCG): 71 Serum beta-hcg (BHCG): O known t known IF (71) Serum beta-hcg (BHCG)::= not known THEN GOTO (73) LDH: ELSE GOTO (72) BHCG value 72 IU/L ELSE GOTO (73) LDH: 73 LDH: O known t known IF (73) LDH::= not known THEN GOTO (75) Other tumor marker? ELSE GOTO (74) LDH value CIBMTR Form 2122 revision 2 (page 9 of 10) Last Updated November 12, 2012.

10 74 ELSE GOTO LDH unit of measure Specify units O U/L O µkat/l ELSE GOTO (75) Other tumor marker? 75 Other tumor marker? IF (75) Other tumor marker?:= no THEN GOTO (78) What is the current status of testicular cancer at the time of this report, or at the time of death? ELSE GOTO (76) Specify tumor marker: 76 Specify tumor marker: ELSE GOTO (77) Specify value: 77 Specify value: ELSE GOTO (78) What is the current status of testicular cancer at the time of this report, or at the time of death? Disease Status at the Time of Assessment for this Reporting Period Questions: What is the current status of testicular cancer at the time of this report, or at the time of death? O complete response t in complete response ELSE GOTO (79) Date the current disease status was established in this reporting period: 79 Date the current disease status was established in this reporting period: - - ELSE GOTO First name First Name: ELSE GOTO Last name Last Name: ELSE GOTO Phone number: Phone number: ELSE GOTO Fax number: Fax number: ELSE GOTO address: address: ELSE GOTO End of Form CIBMTR Form 2122 revision 2 (page 10 of 10) Last Updated November 12, 2012.