**E11LAB CTA 7/3/15 JH 

1. Histologically confirmed adenocarcinoma of the breast

2. Hormone receptor status: estrogen and/or progesterone receptor positive tumor Her2/neu negative tumor by either fluorescent in situ hybridization (FISH) or immunohistochemistry (e.g., 0 or 1+ by DAKO Herceptest)

3. Must have undergone surgery to remove the primary tumor by either a modified radical mastectomy or local excision plus an acceptable axillary procedure (i.e., sentinel lymph node biopsy and/or axillary dissection) within the past 84 days

4. Must have adequate (i.e., ¡Ý 1 mm, if margin width specified) tumor-free margins of resection for invasive and ductal carcinoma in situ; Lobular carcinoma in situ involving the resection margins are allowed

5. Negative axillary nodes as determined by a sentinel lymph node biopsy and/or axillary dissection

6. Lymph nodes that are negative by H & E staining but positive by immunohistochemistry or molecular techniques are considered negative

7. Tumor size 1.1-5.0 cm

8. Tumors that measure 5 mm-1.0 cm are allowed provided there are unfavorable histological features, defined as intermediate or poor nuclear and/or histologic grade or lymphvascular invasion

9. Pathologic tumor size should be used; If microscopic measurement is used and tumor includes ductal carcinoma in situ, the measurement should include only the invasive component of the tumor

10. Tissue specimen from the primary tumor available for diagnostic testing with Oncotype DX to determine Oncotype Recurrence Score

11. No prior Oncotype DX Assay unless patient has a recurrence score of 11-25

12. Patients who develop breast cancer while receiving a selective estrogen-receptor modulator (SERM) (e.g., tamoxifen, toremifene, or raloxifene) or an aromatase inhibitor (e.g., anastrazole, letrozole, or exemestane) for breast cancer prevention or a SERM for other indications (e.g., raloxifene for osteoporosis) are ineligible

13. No prior ipsilateral or contralateral invasive breast cancer, bilateral synchronous cancers, or prior ipsilateral or contralateral ductal carcinoma in situ



Prior/Concurrent Therapy:

1. No prior chemotherapy or radiotherapy for this cancer

2. Prior SERM or aromatase inhibitor therapy that was administered for up to 8 weeks for this cancer is allowed

3. No concurrent radiotherapy with chemotherapy

4. Concurrent enrollment on another CTSU study allowed provided patient is already enrolled on ECOG-PACCT-1 and the treatment options in the other study are consistent with PACCT-1-specified treatment assignment (i.e., chemohormonal therapy or hormonal therapy alone)



Patient Characteristics:

1. Female only

2. Any menopausal status allowed

3. WBC count ¡Ý 3,500/mm3

4. Platelet count ¡Ý 100,000/mm3

5. Creatinine ¡Ü 1.5 mg/dL

6. AST ¡Ü 3 times upper limit of normal

7. Life expectancy ¡Ý 10 years

8. No chronic obstructive pulmonary disease requiring treatment

9. No chronic liver disease (e.g., cirrhosis or chronic active hepatitis)

10. No history of cerebrovascular accident

11. No history of congestive heart failure or other cardiac disease that would contradict the use of an anthracycline (e.g., doxorubicin hydrochloride or epirubicin)

12. No chronic psychiatric condition or other condition that would preclude study compliance

13. Not pregnant or nursing

14. Negative pregnancy test; Fertile patients must use effective nonhormonal contraception (e.g., intrauterine device, condoms, diaphragm, abstinence)

15. No other invasive malignancies within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

CREDENTIALING REQUIRED. Please check your site's credentialing status.
CURRENT SITES CREDENTIALED:
SJMH, Livonia, Lehigh, SJMO

-Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy. Patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible.
-For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st

step registration must be between 21-70 days. For patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must have between 21-77 days.
-Patients have pathologic stage T1-3, N0-1, M-0
-Zubrod PS must be 0-1
-Patients entering on the study after pancreaticoduodenctomy, who have not already started chemotherapy must not have had prior systemic chemotherapy for pancreas cancer.
-For patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, patients must not have received adjuvant chemotherapy with agents other than gemcitabine, nab-paclitaxel, oxaliplatin, fluoropyrimidine, or irinotecan for the current pancreatic cancer.
-Patients must not have had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

 *Credentialing required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
Livonia, Macomb, Oakland, Oakwood, Saginaw, Sparrow, St. Alphonsus, St. John, SJMH, Lehigh
NOTE: the QOL substudy is closed to accrual, as the accrual goal for this component has been met.
-Pathologically proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:
--Gleason score 7-10 + T1c-T2b (palpation) + PSA < 50 ng/mL (includes intermediate- and high-risk patients)
--Gleason score 6 + T2c-T4 (palpation) or > 50% (positive) biopsies + PSA < 50 ng/mL
--Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL
-Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration.
-Patients status post a negative lymph node dissection are not eligible
-No evidence of bone metastases (M0) on bone scan
-Zubrod performance status must be 0-1
-Must not have had prior radical surgery or cryosurgery for prostate cancer
-Must not have had previous pelvic RT, prostate brachytherapy, bilateral orchiectomy, or any RT that would result in overlap of RT fields
-Must not have had previous hormonal therapy, such as LHRH antagonist, anti-androgens, or estrogens
-No use of finasteride within 30d prior to registration
-No use of dutasteride or dutasteride/tamsulosin within 90d prior to registration
-No previous or concurrent cytotoxic chemotherapy for prostate cancer     

**Cosmesis subset is closed to accrual for ALL newly enrolled patients**

**Regarding the strat factor for chemotherapy, answer "yes" for patients who have received chemotherapy previously and "no" for patients who have not received chemotherapy yet.  The registration worksheet is confusing, as it asks if the patient is "intending to receive chemotherapy", but this should be ignored. (Per RTOG, an amendment is coming out to remove this language)**

**See Section 5.0 for registration and credentialing information**

 *Credentials may be required depending on treatment modality. Please check your site's credentialing status.*

SJMH, Livonia, Saginaw, Macomb, St. Alphonsus, Oakland, St. John, LVHN
-Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant

minor salivary gland tumor of the head and neck of the following histologic subtypes:
--intermediate-grade adenocarcinoma or mucoepidermaoid carcinoma
--high-grade adenocarcinoma or mucoepidermoid carcinoma or salivary duct carcinoma
--high-grade acinic cell carcinoma or adenoid cystic carcinoma
-Patients must have had surgincal resection with curative intent within the past 8 weeks
-Pathologic stage T3-4 or N1-3 or T1-2, N0 with close or microscopically positive surgical margin
-Patients must NOT have metastatic disease
-Zubrod PS must be 0-1
-Patients must NOT have macroscopic disease after surgery
-Patients must not have had prior systemic chemotherapy or RT for salivary gland malignancy
-Patients must not have significant pre-existing hearing loss

 *Credentialing required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
Livonia, SJMH, Saginaw, Holy Cross, Sparrow

**This study will be closed to accrual effective 12/01/12**

***All PET/CT imaging must be done on an integrated/hybrid PET/CT machine (a single machine must be used for both PET and CT portions.  Pt CAN NOT move between two different machines for images and then have images fused).  Confirmation with radiology department and subsequent documentation prior to enrollment that PET and CT portions were done on a single integrated machine will be required.  Image submission post enrollment is also required for protocol participation***

DISEASE CHARACTERISTICS:

Histologically confirmed classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)

Previously untreated stage III or IV disease
No nodular lymphocyte predominant disease
Bidimensionally measurable disease
Adequate biopsy samples from original diagnostic specimen must be available for pathologic review

Tissue obtained from core biopsies allowed
No tissue obtained from needle aspirations or cytologies
Must have known HIV status

No multi-drug resistant HIV infection, CD4 counts < 350/mcL, or other concurrent AIDS-defining conditions in HIV-positive patients
HIV-positive patients with CD4 counts = 350/mcL allowed
Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days
PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
Serum erythrocyte sedimentation rate, LDH, hemoglobin, albumin, WBC, and lymphocytes measured within the past 28 days
Not pregnant or nursing
Fertile patients must use effective contraception during and for = 6 months after completion of study therapy
No significant cardiac abnormalities as assessed by MUGA scan or ECHO AND cardiac ejection fraction = 45% in patients with a history of hypertension or cardiac symptoms
Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)

Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible
Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
No significant lung disease with abnormal lung function tests (i.e., DLCO > 25% below predicted after correction for hemoglobin) unless attributable to lymphoma
No requirement for continuous supplemental oxygen therapy
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
No prior solid organ transplantation