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Trial Results

September 07, 2012
Observation as Good as Surgery for Some Men with Prostate Cancer
Many men diagnosed with early-stage prostate cancer could forego radical prostatectomy and live as long as men who have immediate surgery, according to long-awaited results from a clinical trial published July 19, 2012, in the New England Journal of Medicine (NEJM).

August 2012
Chemoprevention for Breast Cancer
Bozovic-Spasojevic I, Azambuja E, McCaskill-Stevens W, Dinh P, Cardoso F.
Cancer Treat Rev. 2012 Aug;38(5):329-39. Review.

June 15, 2012
For Some Skin Cancers, Targeted Drug Hits the Mark
Two studies reported June 7, 2012, in the New England Journal of Medicine indicate that the drug vismodegib (Erivedge™) can elicit responses in people with advanced or metastatic basal cell carcinoma and help shrink or prevent tumors in those with basal cell nevus syndrome.

June 15, 2012
Expanding the Playing Field: Immune-Based Therapy Shows Potential for Lung, Other Cancers
Results from two early-phase clinical trials presented at the 2012 American Society of Clinical Oncology annual meeting provide further evidence that priming the immune system to attack tumors has potential as a treatment for certain cancers.

June 14, 2012
Preoperative Chemotherapy, Radiation Improve Survival in Esophageal Cancer
Patients with esophageal cancer who received chemotherapy and radiation before surgery survived, on average, nearly twice as long as patients treated with surgery alone, according to results of a randomized clinical trial published May 31, 2012, in the New England Journal of Medicine.

June 13, 2012
For Some Breast Cancers, New Drug May Be Treatment Option
Results from an international clinical trial suggest that women with metastatic, HER2-positive breast cancer that is no longer responding to the targeted therapy trastuzumab (Herceptin) may soon have a new treatment option. Women who received the investigational drug trastuzumab emtansine (T-DM1) lived more than 3 months longer without their tumors progressing than women who received the chemotherapy drug capecitabine (Xeloda) and the targeted drug lapatinib (Tykerb).

June 13, 2012
Study Suggests New Treatment Option for Some Lymphomas
Updated findings from a large European clinical trial indicate that patients with some types of lymphoma could initially be treated with the chemotherapy drug bendamustine (Treanda) and the targeted agent rituximab (Rituxan).

June 13, 2012
Study Shows First Effective Drug for Cancer Patients with Peripheral Neuropathy
Results of a phase III trial (CALGB-170601) show that duloxetine (Cymbalta) effectively treats painful peripheral neuropathy caused by certain types of chemotherapy.

June 08, 2012
Effect of State-Mandated Insurance Coverage on Accrual to Community Cancer Clinical Trials
Ellis SD, Carpenter WR, Minasian LM, Weiner BJ. Contemp Clin Trials. 2012 Sep;33(5):933-41. Epub 2012 Jun 8.

June 07, 2012
More Chemotherapy May Help after Initial Treatment for Childhood Leukemia Fails
A study suggests that at least some children diagnosed with acute lymphoblastic leukemia who respond poorly to initial chemotherapy may do better if they receive additional chemotherapy rather than a stem cell transplant.

June 07, 2012
Low-Dose Radioactive Iodine Destroys Thyroid Tissue Left after Surgery
A low dose of radioactive iodine given after surgery for thyroid cancer destroyed (ablated) residual thyroid tissue as effectively as a higher dose, with fewer side effects and less exposure to radiation, according to two European randomized controlled trials published May 3, 2012 in the New England Journal of Medicine.

June 07, 2012
Sigmoidoscopy Proves to Be Effective Screening Tool for Colorectal Cancer
In a large randomized trial involving healthy men and women aged 55 to 74, sigmoidoscopy substantially reduced the incidence of and mortality from colorectal cancer.

April 17, 2012
Many Patients with Cancer Need Better Treatments for Pain
Prospective, observational study of pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer. J Clin Oncol. 2012 Jun 1;30(16):1980-8. Epub 2012 Apr 16.
Fisch MJ, Lee JW, Weiss M, Wagner LI, Chang VT, Cella D, Manola JB, Minasian LM, McCaskill-Stevens W, Mendoza TR, Cleeland CS.

March 07, 2012
Improved Outcomes in the Malnourished Patient: We're Not There Yet
O'Mara A, St Germain D. J Natl Cancer Inst. 2012 Mar 7;104(5):342-3. Epub 2012 Feb 15.

November 01, 2011
Integrating Pain Metrics into Oncology Clinical Trials
Cleeland CS, O'Mara A, Zagari M, Baas C. Clin Cancer Res. 2011 Nov 1;17(21):6646-50.

November 2011
Phase III Trial of Selenium to Prevent Prostate Cancer in Men With High-Grade Prostatic Intraepithelial Neoplasia: SWOG S9917
Marshall JR, Tangen CM, Sakr WA, Wood DP Jr, Berry DL, Klein EA, Lippman SM, Parnes HL, Alberts DS, Jarrard DF, Lee WR, Gaziano JM, Crawford ED, Ely B, Ray M, Davis W, Minasian LM, Thompson IM Jr. Cancer Prev Res (Phila). 2011 Nov;4(11):1761-9. Epub 2011 Sep 6.

October 12, 2011
Vitamin E and the Risk of Prostate Cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT)
Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. JAMA. 2011 Oct 12;306(14):1549-56.

July 20, 2011
Comorbidities in the Aging Breast Cancer Population: Are Current Assessments Leading to Improved Outcomes?

McCaskill-Stevens W, Abrams JS. J Natl Cancer Inst. 2011 Jul 20;103(14):1072-3. Epub 2011 Jun 30.

June 10, 2011
Benefit/Risk Assessment for Breast Cancer Chemoprevention with Raloxifene or Tamoxifen for Women Age 50 Years or Older
Freedman AN, Yu B, Gail MH, Costantino JP, Graubard BI, Vogel VG, Anderson GL, McCaskill-Stevens WJ. Clin Oncol. 2011 Jun 10;29(17):2327-33. Epub 2011 May 2.

February 17, 2011
Dutasteride May Slow the Growth of Early-Stage Prostate Cancer
For men who are undergoing active surveillance for early-stage prostate cancer, the drug dutasteride (Avodart) could help control the disease and prevent the need for more aggressive treatments. The finding, from a randomized, placebo-controlled trial was presented during the 2011 Genitourinary Cancers Symposium. Dutasteride is already approved for treatment of an enlarged prostate gland (benign prostatic hyperplasia).

April 20, 2010
Long-term Follow-up Confirms Breast Cancer Risk Reduction with Raloxifene
The drugs raloxifene (Evista) and tamoxifen both substantially reduce the risk of breast cancer in women at high risk for the disease, but raloxifene causes fewer and less-severe side effects, according to the long-term results of a large breast cancer prevention trial presented yesterday at the American Association for Cancer Research (AACR) annual meeting in Washington, DC.

2010
Effect of yoga on sleep, fatigue, and quality of life
Mustian KM, Palesh O, Sprod L, et al. Effect of yoga on sleep, fatigue, and quality of life: A URCC CCOP randomized, controlled clinical trial among 410 cancer survivors. J Clin Oncol. 28:15s, 2010 (suppl; abstr 9013).

April 01, 2010
Evaluation Of Pregabalin For Alleviating Hot Flashes
Loprinzi CL, Qin R, Balcueva EP, et al. Phase III, randomized, double-blind, placebo-controlled evaluation of pregabalin for alleviating hot flashes, N07C1. J Clin Oncol. 2010 Feb 1;28(4):641-7. Epub 2009 Nov 9. Erratum in: J Clin Oncol. 2010 Apr 1;28(10):1808.

September 2009
Acupressure Bands Are Effective In Reducing Radiation Therapy-Related Nausea
Roscoe JA, Bushunow P, Jean-Pierre P, et al. Acupressure bands are effective in reducing radiation therapy-related nausea. J Pain Symptom Manage. 2009 Sep;38(3):381-9. Epub 2009 Mar 28.

January 07, 2009
Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT)
As the largest prostate cancer prevention trial ever undertaken, the Selenium and Vitamin E Cancer Prevention Trial, or SELECT, has assembled a substantial biorepository of specimens. To help make SELECT resources available to a wider research community, NCI and the Southwest Oncology Group are developing a plan for prostate cancer biology and nutritional science and micronutrient studies. The trial's biorepository includes linked nutritional data, adherence cohort data, and a vast clinical database from semi-annual visits with each participant, and prostate biopsies and surgical specimens collected from a subset of the more than 2,100 men who have been diagnosed with prostate cancer during the course of the trial. DNA has been extracted from the serum of these prostate cancer patients and from an age- and race-matched cohort of control subjects.

2009
Ginger for chemotherapy-related nausea in cancer patients
Ryan JL, Heckler C, Dakhil SR, et al. Ginger for chemotherapy-related nausea in cancer patients: A URCC CCOP randomized, double-blind, placebo-controlled clinical trial of 644 cancer patients. J Clin Oncol. 27:15s, 2009 (suppl; abstr 9511).

November 04, 2008
Selenium and Vitamin E Fail to Reduce Prostate Cancer Risk
The SELECT executive committee made the decision on the study medications based on the recommendation of the trial's Data Safety Monitoring Committee (DSMC). In its most recent review of the data in mid-September, the DSMC concluded that, with participants having been on their study medicat ions for 5 years on average, there was little chance that one or both supplements would reduce the number of cases of prostate cancer.

October 23, 2008
Only Patients With A Wild Type K-Ras Mutation Benefit From EGFR Inhibitors (Cetuximab)
Only patients with a wild type K-Ras mutation benefit from EGFR inhibitors (cetuximab), according to the results of the study, Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/ 5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of Colon, Rectum. Patients who will not benefit from cetuximab can be identified prior to treatment, and avoid treatments risks, side effects, and costs. The study recruited 34% of patients from CCOPs and MB-CCOPs.

October 2008
Treatment Choice Is Better Informed
A trial assessing individualized options for treatment for breast cancer, Trial Assigning Individualized Options for Treatment, or the TAILORx trial, showed patients with a low risk score who are unlikely to have a recurrence can opt to forgo chemotherapy that may yield minimal, if any, benefit. The study, which showed that treatment choice is better informed with the cancer test, accrued 23% of patients from the CCOPs and MB-CCOPs.

May 02, 2007
Transdermal Testosterone In Female Cancer Survivors With Decreased Libido
Barton DL, Wender DB, Sloan JA, et al. Randomized controlled trial to evaluate transdermal testosterone in female cancer survivors with decreased libido; North Central Cancer Treatment Group protocol N02C3. J Natl Cancer Inst. 2007 May 2;99(9):672-9.

April 05, 2006
Low-Dose Isotretinoin Did Not Reduce Second Primary Tumors in Head and Neck Cancer Patients
In a study of 13-cis retinoic acid to prevent second primary cancers with 1,190 head and neck cancer patients, low-dose isotretinoin to prevent second cancers in stage I and II head and neck cancer patients did not reduce the number of second primary tumors in this population. Smoking increased the risk of second primary cancers and death.

May 2006
Pilocarpine During Radiation Therapy
Scarantino C, LeVeque F, Swann RS, et al. Effect of pilocarpine during radiation therapy: Results of RTOG 97-09, a phase III randomized study in head and neck cancer patients. J Support Oncol. 2006 May;4(5):252-8.

October 20, 2005
Trastuzumab Plus Adjuvant Chemotherapy For Operable HER2-Positive Breast Cancer
With 40% of patients from CCOPs and MB-CCOPs, improvement in survival and reduction in early stage breast cancer recurrence was seen. The study was called: Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol to that of Adriamycin and Cyclophosphamide Followed by Taxol Plus Herceptin in Node-Positive Breast Cancer Patients Who Have Tumors that Overexpress HER2.

2005
Radiotherapy for Palliation of Painful Bone Metastases
Hartsell W, Scott C, Bruner D, et al. Randomized trial of short-versus long-course radiotherapy for palliation of painful bone metastases, 2005. J Natl Cancer Inst. 97;98-804.

November 16, 2005
Tamoxifen For The Prevention Of Breast Cancer: Current Status
Known as the Breast Cancer Prevention Trial (BCPT) or the National Surgical Adjuvant Breast and Bowel Project P-1 study, this studied tamoxifen vs. placebo in 13,388 women at increased risk of breast cancer. Women taking tamoxifen had 49% fewer diagnoses of invasive and noninvasive breast cancers. Women on tamoxifen had increased risk of blood clots and uterine cancers; most side effects are temporary. Tamoxifen was approved by FDA in 1998 for reduction of breast cancer risk in women at increased risk after the first results were released in 1998.

2003
Prostate Cancer Prevention Trial (PCPT)
Prostate Cancer Prevention Trial (PCPT) 18,882 men. Men taking finasteride had 25% fewer prostate cancers, but seemed to have a slightly higher incidence of aggressive tumors. Further pathological analysis and data have shown that reduced prostate size contributes to finding more high-grade tumors. Finasteride vs. Placebo with serial PSA screening and end-of-study biopsy. The PCPT biorepository and extended data was used to further explore the initial suggestion that some men taking finasteride were at risk of developing high-grade prostate cancers, and to look at the value of prostate-specific antigen (PSA) for early detection39. (Thompson, et al. N Engl J Med , 2003

2003
Colorectal Adenoma Prevention Study (CAPS)
Colorectal Adenoma Prevention Study (CAPS) 635 colorectal cancer patients. Daily aspirin use reduced the development of adenomas by 35%. Aspirin treatment also reduced the number of adenomas and increased the time before adenomas developed, without significant adverse events. Aspirin vs. placebo in people with surgically-cured early stage colorectal cancer (Sandler et al, N Engl J Med 2003 44

2001
13-cis Retinoic Acid To Prevent Second Primary Cancers in Lung Cancer Patients
Study of 13-cis retinoic acid to prevent second primary cancers 1,166 lung cancer patients. No difference was seen between placebo and intervention in second primary cancers, recurrence, or mortality. Istretinoin to prevent second primary lung cancers in people with stage I non-small cell lung cancer (Lippman, et al. J Natl Cancer Inst 2001, 42 and Lippman et al, ASCO 1998 43 )

December 16, 2000
Venlafaxine In Management Of Hot Flashes
Loprinzi CL, Kugler JW, Sloan JA, et al. Venlafaxine in management of hot flashes in survivors of breast cancer: A randomised controlled trial. Lancet. 2000 Dec 16;356(9247):2059-63.

1999
Treatment of Cancer Anorexia/Cachexia
5 Loprinzi CL, Kugler JW, Sloan JA, et al. Randomized comparison of megestrol acetate versus dexamethasone versus fluoxymesterone for the treatment of cancer anorexia/cachexia. J Clin Oncol. 17(10):3299-3306, 1999.

1993
Megestrol Acetate As Therapy For Patients With Cancer Anorexia And/Or Cachexia
Loprinzi CL, Michalak JC, Schaid DJ, et al. Phase III evaluation of four doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia. J Clin Oncol. 11(4):762-767, 1993.

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