Cart

Cart


Research & Trial Information

SCHEMA

Protocol#: NRG – GI004/SWOG – S1610

Cancer Type: Colorectal Metastatic

Patient Eligibility:

  1. Age  18 years.
  2. ECOG Performance Status of 0, 1 or 2.
  3. Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer.
  4. Tumor determined to be mismatch-repair deficient (dMMR).
  5. An adequate amount of archived tumor tissue, either from primary colorectal cancer site or metastatic lesions, for central confirmation of dMMR status: • Either whole or part of the FFPE block containing tumor tissue; or • At least 9 unstained slides containing tumor sections
  6. Documentation by PET/CT scan, CT scan, or MRI that the patient has untreated measurable metastatic disease.
  7. No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass.
  8. No patients with CNS metastases are excluded.
  9. No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm), no history of intracranial hemorrhage or spinal cord hemorrhage, no ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted and no neurosurgical resection or brain biopsy within 28 days prior to randomization.
  10. Uncontrolled high blood pressure, no Serious or non-healing wound, skin ulcer, or bone fracture and no history of TIA, CVA, GI perforation or arterial thrombotic event within 6 months prior to randomization or symptomatic peripheral ischemia.

     

  11. Other malignancies are excluded unless the patient has completed therapy for the malignancy ≥ 12 months prior to randomization and is considered disease-free. Patients with the following cancers are eligible if diagnosed and treated within the past 12 months: in situ carcinomas or basal cell and squamous cell carcinoma of the skin.
  12. No prior treatment with oxaliplatin chemotherapy within 6 months prior to randomization.
  13. Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents. Patients who have received prior treatment with anti-CTLA-4 may be enrolled provided the following requirements are met:

     Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose to randomization

     No history of severe immune-related adverse effects (CTCAE Grade 3 and 4) from anti-CTLA-4.

  14. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier are excluded; however, the following therapies are allowed:  Hormone-replacement therapy or oral contraception  Herbal therapy > 7 days prior to randomization (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization)  Palliative radiotherapy for bone metastases >14 days prior to randomization.
  15. No treatment with systemic immunostimulatory medications.
  16. No treatment with systemic immunosuppressive medications.
  17. No patients taking bisphosphonate therapy for symptomatic hypercalcemia.
  18. No treatment with any other investigational agent within 4 weeks prior to randomization.
  19. No History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  20. No Severe infections within 28 days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
  21. Signs or symptoms of infection within 14 days prior to randomization.


Research & Trial Information

SCHEMA

Protocol#: ECOG – EA1131

Cancer Type: Breast Adjuvant

Patient Eligibility:

  1. Age ≥ 18 years.
  2. ECOG Performance Status 0 or 1.
  3. Female and male patients must have histologically confirmed invasive breast cancer. Clinical stage II or III, ER- and PR-, HER2 negative, and IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells OR ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6 signals/cells without IHC).

  4. Must have completed definitive resection of primary tumor. Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible.  Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable.  Sentinel node biopsy either pre- or post-neoadjuvant chemotherapy (i.e. at the time of definitive surgery) are allowed. Axillary dissection is encouraged in patients with lymph node  involvement, but is not mandatory.
  5. Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery. Residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination. Please note that in patients that have multifocal or multicentric residual tumors these lesions cannot be added up; the biggest lesion has to measure 1 cm in diameter. This is required due to constraints in DNA extraction for PAM50 analysis. The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast.  Despite lymph node involvement if residual invasive cancer in the breast is < 1 cm in diameter patients are not  eligible for participation.

  6. Radiotherapy may be given before or after protocol treatment per standard of care guidelines.

    Post-mastectomy radiotherapy is required for all patients with the

    following:

    ____ Primary tumor 5 cm (prior to neoadjuvant chemotherapy

    [clinically] or at the time of definitive surgery) or involvement of lymph

    nodes at the time of definitive surgery.

    ____ For patients with primary tumors < 5 cm or without lymph node

    involvement prior to neoadjuvant chemotherapy and at the time of

    definitive surgery, provision of post-mastectomy radiotherapy is at the

    discretion of the treating physician.

    Radiation of regional nodal basins is at the discretion of the treating

    radiation oncologist.

  7. No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort.

  8. Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed. LHRH agonists and adjuvant  bisphosphonate or denosumab use is allowed.

  9. 3.2.6.1 A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:  1) has not undergone a hysterectomy or bilateral  oophorectomy; or 2) has not been naturally

    postmenopausal for at least 24 consecutive months (i.e.,  has had menses at any time in the preceding 24 consecutive months)



Research & Trial Information

SCHEMA

Protocol#: NSABP – B-51

Cancer Type: – Breast Neo-Adjuvant

Patient Eligibility:

  1. The patient must be female.
  2. The patient must be ≥ 18 years old.
  3. The patient must have an ECOG performance status of 0 or 1.
  4. Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy). Clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, MRI, PET scan, or PET/CT scan.
  5. Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma). The FNA or core needle biopsy can be performed either by palpation or by image guidance. Documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted.
  6. Patients must have had ER analysis performed on the primary breast tumor before neoadjuvant therapy according to current ASCO/CAP Guideline Recommendations for hormone receptor testing. If negative for ER, assessment of PgR must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing.
  7. Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible.
  8. Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.
  9. For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization. (If treatment delays occur, chemotherapy must be completed within 14 weeks.) The dose and schedule of the adjuvant chemotherapy are at the investigator’s discretion.
  10. Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
  11. At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer. Acceptable procedures for assessment of axillary nodal status at the time of surgery include: axillary node dissection; sentinel node biopsy alone provided that at least 2 sentinel lymph nodes are removed. Removal of at least 3 sentinel lymph nodes and use of dual tracer for lymphatic mapping are strongly recommended; or sentinel node biopsy followed by axillary node dissection.
  12. Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible.
  13. Patient who have undergone either a total mastectomy or a lumpectomy are eligible. (Patients who have had a nipple-sparing mastectomy are eligible.).
  14. For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist. Additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
  15. For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor.
  16. The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days. Also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days.
  17. The patient must have recovered from surgery with the incision completely healed and no signs of infection.
  18. If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved.
  19. No definitive clinical or radiologic evidence of metastatic disease.
  20. No T4 tumors including inflammatory breast cancer.
  21. No documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone.
  22. No N2 or N3 disease detected clinically or by imaging.
  23. No patients with histologically positive axillary nodes post neoadjuvant therapy.
  24. No patients with microscopic positive margins after definitive surgery.
  25. No synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
  26. No any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
  27. History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.
  28. Any radiation therapy for the currently diagnosed breast cancer prior to randomization.
  29. Prior breast or thoracic RT for any condition.

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Genesys Health System
Hurley Medical Center
Michigan Cancer Consortium

Newsletter

Ⓒ 2019 Genesys Hurley Cancer Institute | All Rights Reserved.

Cart

Cart