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Research & Trial Information

SCHEMA S0820

Protocol#: SWOG – S0820

Cancer Type: Cancer Control & Prevention/Colorectal

Patients Eligibility:

  1. Patients must have a history of Stage 0, I, II or III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy. Adjuvant chemotherapy and RT treatment must have been completed at least 30 days prior to registration.
  2. Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection). The definition of resection does not include endomucosal resection (EMR). Patients that have received total proctocolectomy are ineligible. In addition to segmental resections, the following types of procedures are allowed: Polypectomy: For Tis (Stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met:• Single specimen, completely removed.• Clear margins

    • None of the following must be present: o Moderate or poor differentiation

    o Lymphovascular invasion

    o Perineural invasion

  3. Transanal excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors if NCCN criteria for transanal excision are met.
  4. Patients must be registered between 120 days and 456 days (inclusive) of primary resection. Patients must show no evidence of colorectal cancer based on post-operative colonoscopy (performed at least 120 days after the colon or rectal resection date and prior to registration). Patients with adenomas detected at the one-year postoperative colonoscopy are eligible if all adenomas have been completely removed.
  5. Patients must be at least 18 years of age.
  6. Patients must have a Zubrod Performance Status of 0 – 1.
  7. Patients must not be expecting to receive radiation or additional chemotherapy.
  8. Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis. (NSAID use may not exceed 10 days per month.) Patients may receive daily aspirin for cardiovascular prophylaxis as long as ASA is ≤ 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.


Research & Trial Information

SCHEMA EAQ162CD

Protocol#: ECOG – EAQ162CD

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Age 18 years.
  2. Patients must have a life expectancy of 24 months.
  3. ECOG PS 0-3.
  4. Patients must have a newly diagnosed colon or rectal cancer or rectosigmoid junction (initial diagnosis, either a biopsy or curative surgery, whichever is most recent) within 60 days of registration and have either not yet received radiation or chemotherapy or are starting radiation or chemotherapy on the same day as registration.
  5. Patients must have Stage I, II, or III disease at the time of enrollment and will be treated with curative-intent. This can be defined either clinically or pathologically if they have already undergone surgery. For staging of both colon and rectal cancer.
  6. Patients are not eligible if they are already enrolled on a treatment clinical trial at the time of registration. They can remain on the study if they subsequently enroll on a treatment clinical trial during the study time period.
  7. Patients are not eligible if they are to receive treatment at an outside facility throughout the duration of the trial.
  8. Patients who choose to not receive radiation and/or chemotherapy after a curative-intent surgery are eligible to participate.
  9. Patients with a history of previous malignancy (except non-melanoma skin or cervical in-situ cancer) treated (with either surgery, chemotherapy, and/or radiation) within the last 3 years are not eligible because it is possible that their employment and burden due to cancer care may be impacted by their previous malignancy and therefore add heterogeneity to the study.
  10. Patients with two primary cancers that consist of colon, rectal or colorectal are not eligible.


Research & Trial Information

SCHEMA NRG CC004

Protocol#: NRG – CC004

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Diagnosis of breast or gynecologic cancer, all types (examples are DCIS, LCIS, invasive breast, ovarian, endometrial, vulvar, cervical and vaginal).
  2. Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy).
  3. Post-menopausal
  4. Age ≥ 18.
  5. For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but not current tamoxifen. Prior tamoxifen is permitted with a 30 day wash out period).
  6. Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (<7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study.
  7. Antidepressants for mood and hot flashes, including SSRI’s (that are not CYP2D6 substrates) will be allowed if patients have been on for the last 60 days and the dose is not expected to change during the course of the study.
  8. No diagnosis of depression, Major Depressive Disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on DSM IV diagnoses.
  9. No seizure disorders and history of anorexia or bulimia in the past 5 years.
  10. No stage IV cancer.
  11. No history of Parkinson’s Disease, multiple sclerosis or fibromyalgia.
  12. Males are not permitted to participate.
  13. No patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbituates, and antiepileptic drugs after chronic use.
  14. No patients who discontinue MAO-I’s within 14 days prior to starting the investigational drug.
  15. No poorly controlled hypertension, active bipolar disorder, impaired decision making as determined by the treating physician.
  16. Concurrent use of bupropion.
  17. Concomitant invasive malignancy requiring treatment other than non-melanomatous skin cancer.
  18. Previous or concurrent use of flibanserin.


Research & Trial Information

SCHEMA AFT 39 PROTECT

Protocol#: NRG – AFT-39 (PROTECT)

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Adults (21+) with etastatic cancer of any type (EXCEPT leukemia or indolent [slow growing] lymphoma)
  2. Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy.
  3. Enrolled at any point in their treatment trajectory, meaning during any line of treatment, and at any point during a course or cycle of treatment.
  4. No cognitive deficits that would preclude understanding of consent form and/or questionnaires.
  5. No current participation in a therapeutic clinical trial.
  6. No indolent lymphomas and leukemias.


Research & Trial Information

SCHEMA A221701

Protocol#: Alliance – A221701

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without an endocrine agent. Patients about to receive everolimus for off label use for any cancer are also eligible.
  2. Not currently receiving chemotherapy or any other agent known to cause mucositis or stomatitis. Trastuzumab and ovarian function suppression are allowed.
  3. Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed at least 2 weeks prior to registration.
  4. Not currently suffering from stomatitis/mucositis or mouth ulcers.
  5. Patients should not receive any other agent which would be considered treatment for stomatitis or impact the primary endpoint.
  6. No history of candida infection (thrush) within the last 3 months.
  7. Not currently being treated with corticosteroids.
  8. ECOG Performance Status 0, 1 or 2.
  9. Age ≥ 18 years.


Research & Trial Information

SCHEMA A221602

Protocol#: Alliance – A221602

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Diagnosis of malignant disease of any stage. (Stage I through Stage IV).
  2. No prior history of chemotherapy for any malignancy.
  3. Scheduled to receive intravenous HEC (Highly Emetogenic Chemotherapy) (either cisplatin-containing regimen or doxorubicin and cyclophosphamide [AC]).
  4. No nausea or vomiting 24 hours prior to registration.
  5. No known diagnosis of dementia. Patients with stable treated brain metastases are eligible to participate.
  6. No known history of CNS disease (e.g. seizure disorder).
  7. No treatment with another antipsychotic agent.
  8. No chronic phenothiazine administration, no use of amifostine and No use of quinolone antibiotic therapy.
  9. No radiotherapy within 7 days prior to registration or planned for one week after the current dose of chemotherapy.
  10. Age ≥18 years.
  11. ECOG Performance Status 0, 1 or 2.

 



Research & Trial Information

SCHEMA WF97116

Protocol#: Wake Forest – WF97116

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Women ≥18 years old with history of invasive breast cancer.
  2. Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to enrollment (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).
  3. Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study enrollment and plan to continue for the duration of the study (9 months).
  4. Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted if the patient whose eligibility is being assessed has been on the medication for at least 12 weeks. The dose of this medication must be stable for at least 4 weeks prior to enrollment.
  5. Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment.
  6. Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one SSRI antidepressant to a different SSRI antidepressant) need to be on a stable dose of the new medication for at least 4 weeks prior to enrollment to be eligible.
  7. ECOG performance status 0-2.
  8. No evidence of or suspected recurrent or metastatic disease.
  9. No prior brain irradiation.
  10. No planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease.
  11. No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, or cardiac arrhythmia.
  12. No Major medical conditions that affect cognition, traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
  13. No Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.
  14. No untreated current severe depression. Currently treated depression is permitted if treatment is stable.


Research & Trial Information

SCHEMA URCC 18007

Protocol#: URCC – 18007

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Be at least 18 years of age and female
  2. Been diagnosed with Stage I-III breast cancer.
  3. Be currently breast cancer-free.
  4. Report moderate to severe fatigue in the past week.
  5. Attribute their fatigue to cancer and/or its treatment.
  6. Have completed surgery, radiation, standard dose chemotherapy, and/or targeted therapy 12-60 months previously (participants can be receiving hormonal therapy – i.e., tamoxifen, anastrozole, letrozole, exemestane).
  7. Must not have another medical condition in which fatigue is a prominent symptom as documented in the medical chart (e.g., anemia, autoimmune disease, sleep apnea).
  8. Must not be currently taking Bupropion, Wellbutrin, Forfivo, Aplenzin, or Zyban (i.e., bupropion prescribed for other indications); an anti-depressant including but not limited to an MAOI inhibitor, anti-psychotic, a systemic anti-TNF agent, linezolid, methylene blue, or a systemic corticosteroid (patients who have previously completed treatment with these agents at least one week prior and meet all other eligibility criteria are eligible to participate). Participants should be off an MAOI for at least 2 weeks prior to study entry.
  9. Must not have have a history of renal impairment, cirrhosis, seizures, bulimia or anorexia nervosa and/or history of sensitivity to bupropion.


Research & Trial Information

SCHEMA URCC 16070

Protocol#:  URCC – 16070

Cancer Type: Cancer Control & Prevention

Patient Eligibility:

  1. Have a diagnosis of breast cancer and be chemotherapy naïve. Note: Prior methotrexate for non-cancerous conditions is allowed.
  2. Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin, and/or cyclophosphamide, and/or carboplatin. Herceptin® (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens.
  3. Be scheduled to receive an antiemetic regimen that does not contain Akynzeo®.• For chemotherapy regimens with a high emetic risk, the antiemetic regimen must include an NK-1 antagonist receptor, a 5HT3 receptor antagonist and dexamethasone. Other antiemetics, including additional dexamethasone and olanzapine, may also be included at cycle one.

    • For chemotherapy regimens with a moderate emetic risk, the antiemetic regimen must include a 5HT3 receptor antagonist and dexamethasone. Other antiemetics, including additional dexamethasone and olanzapine, may also be included at cycle one.

  4. Be at least 18 years of age.
  5. Be female.
  6. Have ECOG performance status of 0, 1, or 2
  7. Must not have clinical evidence of current or impending bowel obstruction.
  8. Must not have a known history of central nervous system disease (e.g., brain metastases or a seizure disorder.)
  9. Must not have dementia.
  10. Must not have uncontrolled diabetes mellitus or uncontrolled hyperglycemia, severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician.
  11. Must not have had treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period. Note: Participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., < 5 days).


Research & Trial Information

SCHEMA A011401

Protocol#: A011401

Cancer Type:  Cancer Control & Prevention

Patient Eligibility:

  1. Histologic diagnosis of invasive breast cancer within the past 14 months.
  2. Her-2 negative.
  3. ER and PR negative: T2-3N0 or T0-3N1-3 (patients with disease T0N0, T1N0 and T1N1mi disease are not eligible).
  4. ER and/or PR positive: T0-3N1-3, or T3N0 (patients with T0N0, T1N0, T2N0 or T1N1mi and T2N1mi disease are not eligible).
  5. All adjuvant or neoadjuvant chemotherapy, radiation and surgery completed at least 21 days prior to registration.
  6. Participants must be women.
  7. Age ≥ 18 years.
  8. ECOG Performance Status 0 or 1.
  9. No history of other malignancy within past 4 years and no comorbid conditions that would cause life expectancy of less than 5 years.
  10. No diabetes mellitus currently being treated with insulin or sulfonylurea drugs.
  11. BMI ≥27 kg/m2 at the time of study enrollment.
  12. Self-reported ability to walk at least 2 blocks (at any pace).

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