List of EORTC trials

Last updated

This page is a list of EORTC clinical trials sponsored by the European Organisation for Research and Treatment of Cancer (EORTC).

Contents

Breast cancer

Older studies

Prostate cancer

The following prostate cancer trials have been conducted, among others: [7] [8]

Related Research Articles

<span class="mw-page-title-main">Antiandrogen</span> Class of pharmaceutical drugs

Antiandrogens, also known as androgen antagonists or testosterone blockers, are a class of drugs that prevent androgens like testosterone and dihydrotestosterone (DHT) from mediating their biological effects in the body. They act by blocking the androgen receptor (AR) and/or inhibiting or suppressing androgen production. They can be thought of as the functional opposites of AR agonists, for instance androgens and anabolic steroids (AAS) like testosterone, DHT, and nandrolone and selective androgen receptor modulators (SARMs) like enobosarm. Antiandrogens are one of three types of sex hormone antagonists, the others being antiestrogens and antiprogestogens.

<span class="mw-page-title-main">Bicalutamide</span> Prostate cancer treatment

Bicalutamide, sold under the brand name Casodex among others, is an antiandrogen medication that is primarily used to treat prostate cancer. It is typically used together with a gonadotropin-releasing hormone (GnRH) analogue or surgical removal of the testicles to treat metastatic prostate cancer (mPC). To a lesser extent, it is used at high doses for locally advanced prostate cancer (LAPC) as a monotherapy without castration. Bicalutamide was also previously used as monotherapy to treat localized prostate cancer (LPC), but authorization for this use was withdrawn following unfavorable trial findings. Besides prostate cancer, bicalutamide is limitedly used in the treatment of excessive hair growth and scalp hair loss in women, as a puberty blocker and component of feminizing hormone therapy for transgender girls and women, to treat gonadotropin-independent early puberty in boys, and to prevent overly long-lasting erections in men. It is taken by mouth.

<span class="mw-page-title-main">Polyestradiol phosphate</span> Chemical compound

Polyestradiol phosphate (PEP), sold under the brand name Estradurin, is an estrogen medication which is used primarily in the treatment of prostate cancer in men. It is also used in women to treat breast cancer, as a component of hormone therapy to treat low estrogen levels and menopausal symptoms, and as a component of feminizing hormone therapy for transgender women. It is given by injection into muscle once every four weeks.

<span class="mw-page-title-main">Flutamide</span> Chemical compound

Flutamide, sold under the brand name Eulexin among others, is a nonsteroidal antiandrogen (NSAA) which is used primarily to treat prostate cancer. It is also used in the treatment of androgen-dependent conditions like acne, excessive hair growth, and high androgen levels in women. It is taken by mouth, usually three times per day.

<span class="mw-page-title-main">Nilutamide</span> Chemical compound

Nilutamide, sold under the brand names Nilandron and Anandron, is a nonsteroidal antiandrogen (NSAA) which is used in the treatment of prostate cancer. It has also been studied as a component of feminizing hormone therapy for transgender women and to treat acne and seborrhea in women. It is taken by mouth.

<span class="mw-page-title-main">Megestrol acetate</span> Pharmaceutical drug

Megestrol acetate (MGA), sold under the brand name Megace among others, is a progestin medication which is used mainly as an appetite stimulant to treat wasting syndromes such as cachexia. It is also used to treat breast cancer and endometrial cancer, and has been used in birth control. Megestrol acetate is generally formulated alone, although it has been combined with estrogens in birth control formulations. It is usually taken by mouth.

Hormonal therapy in oncology is hormone therapy for cancer and is one of the major modalities of medical oncology, others being cytotoxic chemotherapy and targeted therapy (biotherapeutics). It involves the manipulation of the endocrine system through exogenous or external administration of specific hormones, particularly steroid hormones, or drugs which inhibit the production or activity of such hormones. Because steroid hormones are powerful drivers of gene expression in certain cancer cells, changing the levels or activity of certain hormones can cause certain cancers to cease growing, or even undergo cell death. Surgical removal of endocrine organs, such as orchiectomy and oophorectomy can also be employed as a form of hormonal therapy.

Feminizing hormone therapy, also known as transfeminine hormone therapy, is hormone therapy and sex reassignment therapy to change the secondary sex characteristics of transgender people from masculine or androgynous to feminine. It is a common type of transgender hormone therapy and is used to treat transgender women and non-binary transfeminine individuals. Some, in particular intersex people, but also some non-transgender people, take this form of therapy according to their personal needs and preferences.

<span class="mw-page-title-main">Enzalutamide</span> Antiandrogen medication used in treatment of prostate cancer

Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen (NSAA) medication which is used in the treatment of prostate cancer. It is indicated for use in conjunction with castration in the treatment of metastatic castration-resistant prostate cancer (mCRPC), nonmetastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer (mCSPC). It is taken by mouth.

<span class="mw-page-title-main">Chlormadinone acetate</span> Chemical compound

Chlormadinone acetate (CMA), sold under the brand names Belara, Gynorelle, Lutéran, and Prostal among others, is a progestin and antiandrogen medication which is used in birth control pills to prevent pregnancy, as a component of menopausal hormone therapy, in the treatment of gynecological disorders, and in the treatment of androgen-dependent conditions like enlarged prostate and prostate cancer in men and acne and hirsutism in women. It is available both at a low dose in combination with an estrogen in birth control pills and, in a few countries like France and Japan, at low, moderate, and high doses alone for various indications. It is taken by mouth.

<span class="mw-page-title-main">Estradiol undecylate</span> Chemical compound

Estradiol undecylate, also known as estradiol undecanoate and formerly sold under the brand names Delestrec and Progynon Depot 100 among others, is an estrogen medication which has been used in the treatment of prostate cancer in men. It has also been used as a part of hormone therapy for transgender women. Although estradiol undecylate has been used in the past, it was discontinued .The medication has been given by injection into muscle usually once a month.

<span class="mw-page-title-main">Cyproterone acetate</span> Chemical compound

Cyproterone acetate (CPA), sold alone under the brand name Androcur or with ethinylestradiol under the brand names Diane or Diane-35 among others, is an antiandrogen and progestin medication used in the treatment of androgen-dependent conditions such as acne, excessive body hair growth, early puberty, and prostate cancer, as a component of feminizing hormone therapy for transgender individuals, and in birth control pills. It is formulated and used both alone and in combination with an estrogen. CPA is taken by mouth one to three times per day.

The medical uses of bicalutamide, a nonsteroidal antiandrogen (NSAA), include the treatment of androgen-dependent conditions and hormone therapy to block the effects of androgens. Indications for bicalutamide include the treatment of prostate cancer in men, skin and hair conditions such as acne, seborrhea, hirsutism, and pattern hair loss in women, high testosterone levels in women, hormone therapy in transgender women, as a puberty blocker to prevent puberty in transgender girls and to treat early puberty in boys, and the treatment of long-lasting erections in men. It may also have some value in the treatment of paraphilias and hypersexuality in men.

The side effects of bicalutamide, a nonsteroidal antiandrogen (NSAA), including its frequent and rare side effects, have been well-studied and characterized. The most common side effects of bicalutamide monotherapy in men include breast tenderness, breast growth, feminization, demasculinization, and hot flashes. Less common side effects of bicalutamide monotherapy in men include sexual dysfunction, depression, fatigue, weakness, and anemia. Bicalutamide is well tolerated and has few side effects in women. General side effects of bicalutamide that may occur in either sex include diarrhea, constipation, abdominal pain, nausea, dry skin, itching, and rash.

Comparison of the nonsteroidal antiandrogen (NSAA) bicalutamide with other antiandrogens reveals differences between the medications in terms of efficacy, tolerability, safety, and other parameters. Relative to the other first-generation NSAAs, flutamide and nilutamide, bicalutamide shows improved potency, efficacy, tolerability, and safety, and has largely replaced these medications in clinical practice. Compared to the second-generation NSAAs, enzalutamide and apalutamide, bicalutamide has inferior potency and efficacy but similar tolerability and safety and a lower propensity for drug interactions.

<span class="mw-page-title-main">Pharmacology of bicalutamide</span>

The pharmacology of bicalutamide is the study of the pharmacodynamic and pharmacokinetic properties of the nonsteroidal antiandrogen (NSAA) bicalutamide. In terms of pharmacodynamics, bicalutamide acts as a selective antagonist of the androgen receptor (AR), the biological target of androgens like testosterone and dihydrotestosterone (DHT). It has no capacity to activate the AR. It does not decrease androgen levels and has no other important hormonal activity. The medication has progonadotropic effects due to its AR antagonist activity and can increase androgen, estrogen, and neurosteroid production and levels. This results in a variety of differences of bicalutamide monotherapy compared to surgical and medical castration, such as indirect estrogenic effects and associated benefits like preservation of sexual function and drawbacks like gynecomastia. Bicalutamide can paradoxically stimulate late-stage prostate cancer due to accumulated mutations in the cancer. When used as a monotherapy, bicalutamide can induce breast development in males due to its estrogenic effects. Unlike other kinds of antiandrogens, it may have less adverse effect on the testes and fertility.

<span class="mw-page-title-main">Pharmacology of cyproterone acetate</span>

The pharmacology of cyproterone acetate (CPA) concerns the pharmacology of the steroidal antiandrogen and progestin medication cyproterone acetate.

The side effects of cyproterone acetate (CPA), a steroidal antiandrogen and progestin, including its frequent and rare side effects, have been studied and characterized. It is generally well-tolerated and has a mild side-effect profile, regardless of dosage, when it used as a progestin or antiandrogen in combination with an estrogen such as ethinylestradiol or estradiol valerate in women. Side effects of CPA include hypogonadism and associated symptoms such as demasculinization, sexual dysfunction, infertility, and osteoporosis; breast changes such as breast tenderness, enlargement, and gynecomastia; emotional changes such as fatigue and depression; and other side effects such as vitamin B12 deficiency, weak glucocorticoid effects, and elevated liver enzymes. Weight gain can occur with CPA when it is used at high doses. Some of the side effects of CPA can be improved or fully prevented if it is combined with an estrogen to prevent estrogen deficiency. Few quantitative data are available on many of the potential side effects of CPA. Pooled tolerability data for CPA is not available in the literature.

The Scandinavian Prostate Cancer Group (SPCG) is a group of scientific researchers who have conducted a series of clinical trials of treatments for prostate cancer. The group was founded in 1981 and the first study, SPCG-1, began in 1984.

The FinnProstate Group (FP), or FinnProstate Study Group, is a group of scientific researchers in Finland who have conducted a series of clinical trials of treatments for prostate cancer. The first publication by the group was in 1985 and the latest publication was in 2019.

References

  1. ↑ Vermeulen MA, Slaets L, Cardoso F, Giordano SH, Tryfonidis K, van Diest PJ, et al. (September 2017). "Pathological characterisation of male breast cancer: Results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program" (PDF). European Journal of Cancer. 82: 219–227. doi:10.1016/j.ejca.2017.01.034. PMID   28292559.
  2. ↑ Cardoso F, Bartlett JM, Slaets L, van Deurzen CH, van Leeuwen-Stok E, Porter P, et al. (February 2018). "Characterization of male breast cancer: results of the EORTC 10085/TBCRC/BIG/NABCG International Male Breast Cancer Program". Annals of Oncology. 29 (2): 405–417. doi:10.1093/annonc/mdx651. PMC   5834077 . PMID   29092024.
  3. ↑ Beex L, Rose C, Mouridsen H, Jassem J, Nooij M, Estape J, et al. (December 2006). "Continuous versus intermittent tamoxifen versus intermittent/alternated tamoxifen and medroxyprogesterone acetate as first line endocrine treatment in advanced breast cancer: an EORTC phase III study (10863)". European Journal of Cancer. 42 (18): 3178–3185. doi:10.1016/j.ejca.2006.08.020. PMID   17045796.
  4. ↑ Atalay G, Dirix L, Biganzoli L, Beex L, Nooij M, Cameron D, et al. (February 2004). "The effect of exemestane on serum lipid profile in postmenopausal women with metastatic breast cancer: a companion study to EORTC Trial 10951, 'Randomized phase II study in first line hormonal treatment for metastatic breast cancer with exemestane or tamoxifen in postmenopausal patients'". Annals of Oncology. 15 (2): 211–217. doi: 10.1093/annonc/mdh064 . PMID   14760111.
  5. ↑ Heuson JC, Engelsman E, Blonk-Van Der Wijst J, Maass H, Drochmans A, Michel J, et al. (June 1975). "Comparative trial of nafoxidine and ethinyloestradiol in advanced breast cancer: an E.O.R.T.C. study". British Medical Journal. 2 (5973): 711–713. doi:10.1136/bmj.2.5973.711. PMC   1673940 . PMID   1095121.
  6. ↑ Engelsman E, Heuson JC, Blonk Van Der Wijst J, Drochmans A, Maass H, Cheix F, et al. (June 1975). "Controlled clinical trial of L-dopa and nafoxidine in advanced breast cancer: an E.O.R.T.C. study". British Medical Journal. 2 (5973): 714–715. doi:10.1136/bmj.2.5973.714. PMC   1673916 . PMID   1095122.
  7. 1 2 3 4 5 6 7 Denis L (May 1998). "European Organization for Research and Treatment of Cancer (EORTC) prostate cancer trials, 1976-1996". Urology. 51 (5A Suppl): 50–57. doi:10.1016/s0090-4295(98)00076-4. PMID   9610558.
  8. ↑ Bollack C, Rougeron G (1988). "Hormonal therapy trials in prostatic cancer. An EORTC Genitourinary Group study". American Journal of Clinical Oncology. 11 (Suppl 2): S156–S159. doi:10.1097/00000421-198801102-00037. PMID   2977270. S2CID   20422041.
  9. 1 2 Pavone-Macaluso M, Lund F, Mulder JH, Smith PH, De Pauw M, Sylvester R (1980). "EORTC protocols in prostatic cancer. An interim report". Scandinavian Journal of Urology and Nephrology. 55 (Supplementum): 163–168. PMID   6938020.
  10. ↑ Pavone-Macaluso M, Schröder FH, de Voogt HJ, Viggiano G, Barasolo E, Lardennois B, et al. (1989). "EORTC protocol 30761: a randomized study of non-metastatic and metastatic prostatic cancer treated by cyproterone acetate versus diethylstilbestrol and medroxyprogesterone acetate. European Organization for Research on Treatment of Cancer Urological Group". Progress in Clinical and Biological Research. 303: 111–116. PMID   2528735.
  11. ↑ Pavone-Macaluso M, Ingargiola GB, de Voogt H, Viggiano G, Barasolo E, Lardennois B, et al. (1987). "Cyproterone acetate versus medroxyprogesterone acetate versus diethylstilbestrol in the treatment of prostate cancer: results from EORTC Study 30761". Progress in Clinical and Biological Research. 243A: 379–382. PMID   2958862.
  12. 1 2 de Voogt HJ, Smith PH, Pavone-Macaluso M, de Pauw M, Suciu S (February 1986). "Cardiovascular side effects of diethylstilbestrol, cyproterone acetate, medroxyprogesterone acetate and estramustine phosphate used for the treatment of advanced prostatic cancer: results from European Organization for Research on Treatment of Cancer trials 30761 and 30762". The Journal of Urology. 135 (2): 303–307. doi:10.1016/s0022-5347(17)45620-5. PMID   2935644.
  13. ↑ Smith PH, Robinson M, Richards B, Suciu S, De Pauw M, Sylvester R, Denis L (June 1984). "Estramustine phosphate in prostate cancer. EORTC experience: preliminary results of Protocol 30762". Urology. 23 (6 Suppl): 64–68. doi:10.1016/s0090-4295(84)80101-6. PMID   6375083.
  14. ↑ Robinson MR, Smith PH, Richards B, Newling DW, de Pauw M, Sylvester R (1995). "The final analysis of the EORTC Genito-Urinary Tract Cancer Co-Operative Group phase III clinical trial (protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate". European Urology. 28 (4): 273–283. doi:10.1159/000475067. PMID   8575493.
  15. ↑ Robinson MR (1988). "EORTC protocol 30805: a phase III trial comparing orchidectomy versus orchidectomy and cyproterone acetate and low dose stilboestrol in the management of metastatic carcinoma of the prostate". Progress in Clinical and Biological Research. 260: 101–110. PMID   2966402.
  16. ↑ Robinson MR (1987). "Complete androgen blockade: the EORTC experience comparing orchidectomy versus orchidectomy plus cyproterone acetate versus low-dose stilboestrol in the treatment of metastatic carcinoma of the prostate". Progress in Clinical and Biological Research. 243A: 383–390. PMID   2958863.
  17. ↑ de Voogt HJ, Klijn JG, Studer U, Schröder F, Sylvester R, De Pauw M (December 1990). "Orchidectomy versus Buserelin in combination with cyproterone acetate, for 2 weeks or continuously, in the treatment of metastatic prostatic cancer. Preliminary results of EORTC-trial 30843". The Journal of Steroid Biochemistry and Molecular Biology. 37 (6): 965–969. doi:10.1016/0960-0760(90)90451-p. PMID   2149509. S2CID   13439306.
  18. ↑ de Voogt HJ, Studer U, Schröder FH, Klijn JG, de Pauw M, Sylvester R (1998). "Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer. Final analysis of EORTC GU Group Trial 30843. European Organization for Research and Treatment of Cancer (EROTC) Genito-Urinary Tract Cancer Cooperative Group". European Urology. 33 (2): 152–158. doi:10.1159/000019547. PMID   9519356. S2CID   209144445.
  19. ↑ Carvalho AP, de Moura JL, Denis L, Newling D, Smith P, Bono A, et al. (1989). "Zoladex and flutamide vs orchidectomy: a phase III EORTC 30853 trial. EORTC Urological Group". Progress in Clinical and Biological Research. 303: 129–143. PMID   2528736.
  20. ↑ Keuppens F, Denis L, Smith P, Carvalho AP, Newling D, Bond A, et al. (September 1990). "Zoladex and flutamide versus bilateral orchiectomy. A randomized phase III EORTC 30853 study. The EORTC GU Group". Cancer. 66 (5 Suppl): 1045–1057. doi: 10.1002/cncr.1990.66.s5.1045 . PMID   2144206. S2CID   23659092.
  21. ↑ Denis LJ, Keuppens F, Smith PH, Whelan P, de Moura JL, Newling D, et al. (1998). "Maximal androgen blockade: final analysis of EORTC phase III trial 30853. EORTC Genito-Urinary Tract Cancer Cooperative Group and the EORTC Data Center". European Urology. 33 (2): 144–151. doi:10.1159/000019546. PMID   9519355. S2CID   13056714.
  22. ↑ Schröder FH, Collette L, de Reijke TM, Whelan P (January 2000). "Prostate cancer treated by anti-androgens: is sexual function preserved? EORTC Genitourinary Group. European Organization for Research and Treatment of Cancer". British Journal of Cancer. 82 (2): 283–290. doi:10.1054/bjoc.1999.0916. PMC   2363280 . PMID   10646878.
  23. ↑ Collette L, de Reijke TM, Schröder FH (August 2003). "Prostate specific antigen: a prognostic marker of survival in good prognosis metastatic prostate cancer? (EORTC 30892)". European Urology. 44 (2): 182–9, discussion 189. doi:10.1016/s0302-2838(03)00251-3. PMID   12875936.
  24. ↑ Schröder FH, Whelan P, de Reijke TM, Kurth KH, Pavone-Macaluso M, Mattelaer J, et al. (April 2004). "Metastatic prostate cancer treated by flutamide versus cyproterone acetate. Final analysis of the "European Organization for Research and Treatment of Cancer" (EORTC) Protocol 30892". European Urology. 45 (4): 457–464. doi:10.1016/j.eururo.2003.11.016. PMID   15041109.
  25. ↑ Kil PJ, Goldschmidt HM, Wieggers BJ, Kariakine OB, Studer UE, Whelan P, et al. (January 2003). "Tissue polypeptide-specific antigen (TPS) determinations before and during intermittent maximal androgen blockade in patients with metastatic prostatic carcinoma". European Urology. 43 (1): 31–38. doi:10.1016/s0302-2838(02)00499-2. PMID   12507541.
  26. ↑ de Reijke TM (1997). "Intermittent androgen deprivation in advanced prostate cancer" (PDF). Urological Research. 25 (Suppl 2): S63–S66. doi:10.1007/BF00941990. PMID   9144889. S2CID   31327672.
  27. ↑ Albrecht W, Collette L, Fava C, Kariakine OB, Whelan P, Studer UE, et al. (November 2003). "Intermittent maximal androgen blockade in patients with metastatic prostate cancer: an EORTC feasibility study". European Urology. 44 (5): 505–511. doi:10.1016/s0302-2838(03)00375-0. PMID   14572746.
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