Study Summary
This trial will test the effectiveness of a new chemotherapy regimen for uterine serous carcinoma, which is an aggressive type of endometrial cancer that is difficult to treat.
Eligible Conditions
- Uterine Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 2 years post diagnosis
2 years post diagnosis
Feasibility of above regimen in women with advanced stage USC
Incidence of Treatment-related Adverse Events
Week 26
Patient quality of life
Trial Safety
Phase-Based Safety
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
0 Treatment Group
0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years post diagnosis
Who is running the clinical trial?
Northwell HealthLead Sponsor
432 Previous Clinical Trials
466,978 Total Patients Enrolled
Karin Shih, MDPrincipal InvestigatorNorthwell Health
Eligibility Criteria
Age 18 - 99 · Female Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Goff, Barbara A., Daniel Kato, Rodney A. Schmidt, Marit Ek, Judith A. Ferry, Howard G. Muntz, Joanna M. Cain, Hisham K. Tamimi, David C. Figge, and Benjamin E. Greer. 1994. “Uterine Papillary Serous Carcinoma: Patterns of Metastatic Spread”. Gynecologic Oncology. Elsevier BV. doi:10.1006/gyno.1994.1208.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Jolly, Shruti, Carlos E. Vargas, Tushar Kumar, Sheldon A. Weiner, Donald S. Brabbins, Peter Y. Chen, William Floyd, and Alvaro A. Martinez. 2006. “The Impact of Age on Long-term Outcome in Patients with Endometrial Cancer Treated with Postoperative Radiation”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2006.01.038.
- Sutton, Gregory, Janice H. Axelrod, Brian N. Bundy, Tapan Roy, Howard Homesley, Roger B. Lee, Paola A. Gehrig, and Richard Zaino. 2006. “Adjuvant Whole Abdominal Irradiation in Clinical Stages I and II Papillary Serous or Clear Cell Carcinoma of the Endometrium: A Phase II Study of the Gynecologic Oncology Group”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2005.08.037.
- Mayr, N A, B C Wen, J A Benda, J I Sorosky, C S Davis, R W Fuller, and D H Hussey. 1995. “Postoperative Radiation Therapy in Clinical Stage I Endometrial Cancer: Corpus, Cervical, and Lower Uterine Segment Involvement--patterns of Failure.”. Radiology. Radiological Society of North America (RSNA). doi:10.1148/radiology.196.2.7617840.
- Randall, Marcus E., Virginia L. Filiaci, Hyman Muss, Nick M. Spirtos, Robert S. Mannel, Jeffrey Fowler, J. Tate Thigpen, and Jo Ann Benda. 2006. “Randomized Phase III Trial of Whole-abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2004.00.7617.
- Sherman, Mark E., and Susan S. Devesa. 2003. “Analysis of Racial Differences in Incidence, Survival, and Mortality for Malignant Tumors of the Uterine Corpus”. Cancer. Wiley. doi:10.1002/cncr.11484.
- Elliott, P., D. Green, A. Coates, M. Krieger, P. Russell, M. Coppleson, J. Solomon, and M. Tattersall. 1994. “The Efficacy of Postoperative Vaginal Irradiation in Preventing Vaginal Recurrence in Endometrial Cancer”. International Journal of Gynecologic Cancer. BMJ. doi:10.1046/j.1525-1438.1994.04020084.x.
- Major, Francis J., John A. Blessing, Steven G. Silverberg, C. Paul Morrow, William T. Creasman, John L. Currie, Edgardo Yordan, and Mark F. Brady. 1993. “Prognostic Factors in Early-stage Uterine Sarcoma: A Gynecologic Oncology Group Study”. Cancer. Wiley. doi:10.1002/cncr.2820710440.
- O'Hanlan, Katherine A., Phyllis A. Levine, Dawn Harbatkin, Cheryl Feiner, Gary L. Goldberg, Joan G. Jones, and Lorna Rodriguez-Rodriguez. 1990. “Virulence of Papillary Endometrial Carcinoma”. Gynecologic Oncology. Elsevier BV. doi:10.1016/0090-8258(90)90318-f.
- Kucera, H., N. Vavra, and K. Weghaupt. 1989. “Zum wert der postoperativen bestrahlung beim endometriumkarzinom im pathohistologischen stadium I”. Geburtshilfe und frauenheilkunde. Georg Thieme Verlag KG. doi:10.1055/s-2008-1026666.
- Greven, Kathryn M., Mark Randall, James Fanning, Marianne Bahktar, Paul Duray, Albert Peters, and Walter J. Curran Jr.. 1990. “Patterns of Failure in Patients with Stage I, Grade 3 Carcinoma of the Endometrium”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/0360-3016(90)90477-2.
- Lanciano, Rachelle M., Walter J. Curran Jr., Kathryn M. Greven, James Fanning, Patrick Stafford, Marcus E. Randall, and Gerald E. Hanks. 1990. “Influence of Grade, Histologic Subtype, and Timing of Radiotherapy on Outcome Among Patients with Stage II Carcinoma of the Endometrium”. Gynecologic Oncology. Elsevier BV. doi:10.1016/0090-8258(90)90268-p.
- Morrow, C.Paul, Brian N. Bundy, Robert J. Kurman, William T. Creasman, Paul Heller, Howard D. Homesley, and James E. Graham. 1991. “Relationship Between Surgical-pathological Risk Factors and Outcome in Clinical Stage I and II Carcinoma of the Endometrium: A Gynecologic Oncology Group Study”. Gynecologic Oncology. Elsevier BV. doi:10.1016/0090-8258(91)90086-k.
- Sutton, Gregory, Janice H. Axelrod, Brian N. Bundy, Tapan Roy, Howard D. Homesley, John H. Malfetano, Borys R. Mychalczak, and Mary E. King. 2005. “Whole Abdominal Radiotherapy in the Adjuvant Treatment of Patients with Stage III and IV Endometrial Cancer: A Gynecologic Oncology Group Study”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2005.03.011.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Hendrickson, Michael, Jon Ross, Patricia Eifel, Alvaro Martinez, and Richard Kempson. 1982. “Uterine Papillary Serous Carcinoma”. The American Journal of Surgical Pathology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000478-198203000-00002.
- CalaisLaurence Vitu, Gilles, Philippe Descamps, Gilles Body, Agnes Reynaud-Bougnoux, Jacques Lansac, Philippe Bougnoux, and Olivier Le Floch. 1990. “Preoperative or Postoperative Brachytherapy for Patients with Endometrial Carcinoma Stage I and II”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/0360-3016(90)90476-z.
- Carey, Mark S., Gregory J. O'Connell, Curtis R. Johanson, Michael D. Goodyear, K.Joan Murphy, Dean M. Daya, Alex Schepansky, Ann Peloquin, and Brenda J. Lumsden. 1995. “Good Outcome Associated with a Standardized Treatment Protocol Using Selective Postoperative Radiation in Patients with Clinical Stage I Adenocarcinoma of the Endometrium”. Gynecologic Oncology. Elsevier BV. doi:10.1006/gyno.1995.1115.
- Greven, Kathryn M., Walter J. Curran Jr., Richard Whittington, James Fanning, Marcus E. Randall, James Wilder, and Albert J. Peters. 1989. “Analysis of Failure Patterns in Stage III Endometrial Carcinoma and Therapeutic Implications”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/0360-3016(89)90367-2.
- Grigsby, Perry W., Carlos A. Perez, H.Marvin Camel, M.S. Kao, and Andrew E. Galakatos. 1985. “Stage II Carcinoma of the Endometrium: Results of Therapy and Prognostic Factors”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/0360-3016(85)90272-x.
- Fleming, Gini F., Virginia L. Brunetto, David Cella, Katherine Y. Look, Gary C. Reid, Adnan R. Munkarah, Richard Kline, Robert A. Burger, Annekathryn Goodman, and R. Tucker Burks. 2004. “Phase III Trial of Doxorubicin Plus Cisplatin with or Without Paclitaxel Plus Filgrastim in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2004.07.184.
- Gupta, Divya, Marc J. Gunter, Kathleen Yang, Stephen Lee, Lisa Zuckerwise, Lee-may Chen, Gary L. Goldberg, and Gloria S. Huang. 2011. “Performance of Serum CA125 as a Prognostic Biomarker in Patients with Uterine Papillary Serous Carcinoma”. International Journal of Gynecologic Cancer. BMJ. doi:10.1097/igc.0b013e31821091b5.
- Kato, Daniel T., Judith A. Ferry, Annekathryn Goodman, Jana Sullinger, Robert E. Scully, Barbara A. Goff, Arlan F. Fuller, Jr., and Laurel W. Rice. 1995. “Uterine Papillary Serous Carcinoma (UPSC): A Clinicopathologic Study of 30 Cases”. Gynecologic Oncology. Elsevier BV. doi:10.1006/gyno.1995.9957.
- Randall, Marcus E., James Wilder, Kathryn Greven, and Milton Raben. 1990. “Role of Intracavitary Cuff Boost After Adjuvant External Irradiation in Early Endometrial Carcinoma”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/0360-3016(90)90133-5.
- MOORE, KATHLEEN N., and AMANDA NICKLES FADER. 2011. “Uterine Papillary Serous Carcinoma”. Clinical Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/grf.0b013e318218c755.
- Smith, Ron S, Daniel S Kapp, Qing Chen, and Nelson N.H Teng. 2000. “Treatment of High-risk Uterine Cancer with Whole Abdominopelvic Radiation Therapy”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/s0360-3016(00)00724-0.
- Ball, Harrison G., John A. Blessing, Samuel S. Lentz, and David G. Mutch. 1996. “A Phase II Trial of Paclitaxel in Patients with Advanced or Recurrent Adenocarcinoma of the Endometrium: A Gynecologic Oncology Group Study”. Gynecologic Oncology. Elsevier BV. doi:10.1006/gyno.1996.0227.
- Thigpen, J. Tate, Mark F. Brady, Howard D. Homesley, John Malfetano, Brent DuBeshter, Robert A. Burger, and Shu Liao. 2004. “Phase III Trial of Doxorubicin with or Without Cisplatin in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2004.02.088.
- Fleming, Gini F., Virginia L. Brunetto, David Cella, Katherine Y. Look, Gary C. Reid, Adnan R. Munkarah, Richard Kline, Robert A. Burger, Annekathryn Goodman, and R. Tucker Burks. 2004. “Phase III Trial of Doxorubicin Plus Cisplatin with or Without Paclitaxel Plus Filgrastim in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2004.07.184.
- Mayr, N A, B C Wen, J A Benda, J I Sorosky, C S Davis, R W Fuller, and D H Hussey. 1995. “Postoperative Radiation Therapy in Clinical Stage I Endometrial Cancer: Corpus, Cervical, and Lower Uterine Segment Involvement--patterns of Failure.”. Radiology. Radiological Society of North America (RSNA). doi:10.1148/radiology.196.2.7617840.
- Mayr NA, Wen BC, Benda JA, Sorosky JI, Davis CS, Fuller RW, Hussey DH. Postoperative radiation therapy in clinical stage I endometrial cancer: corpus, cervical, and lower uterine segment involvement--patterns of failure. Radiology. 1995 Aug;196(2):323-8. doi: 10.1148/radiology.196.2.7617840.
- Morrow CP, Bundy BN, Kurman RJ, Creasman WT, Heller P, Homesley HD, Graham JE. Relationship between surgical-pathological risk factors and outcome in clinical stage I and II carcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1991 Jan;40(1):55-65. doi: 10.1016/0090-8258(91)90086-k.
- Major FJ, Blessing JA, Silverberg SG, Morrow CP, Creasman WT, Currie JL, Yordan E, Brady MF. Prognostic factors in early-stage uterine sarcoma. A Gynecologic Oncology Group study. Cancer. 1993 Feb 15;71(4 Suppl):1702-9. doi: 10.1002/cncr.2820710440.
- Greven KM, Lanciano RM, Corn B, Case D, Randall ME. Pathologic stage III endometrial carcinoma. Prognostic factors and patterns of recurrence. Cancer. 1993 Jun 1;71(11):3697-702. doi: 10.1002/1097-0142(19930601)71:113.0.co;2-u.
- Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. doi: 10.1200/JCO.2004.07.184.
- Thigpen JT, Brady MF, Homesley HD, Malfetano J, DuBeshter B, Burger RA, Liao S. Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a gynecologic oncology group study. J Clin Oncol. 2004 Oct 1;22(19):3902-8. doi: 10.1200/JCO.2004.02.088.
- Hendrickson M, Ross J, Eifel P, Martinez A, Kempson R. Uterine papillary serous carcinoma: a highly malignant form of endometrial adenocarcinoma. Am J Surg Pathol. 1982 Mar;6(2):93-108. doi: 10.1097/00000478-198203000-00002.
- Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Jan 1;24(1):36-44. doi: 10.1200/JCO.2004.00.7617. Epub 2005 Dec 5.
- Sutton G, Axelrod JH, Bundy BN, Roy T, Homesley HD, Malfetano JH, Mychalczak BR, King ME. Whole abdominal radiotherapy in the adjuvant treatment of patients with stage III and IV endometrial cancer: a gynecologic oncology group study. Gynecol Oncol. 2005 Jun;97(3):755-63. doi: 10.1016/j.ygyno.2005.03.011.
- Sutton G, Axelrod JH, Bundy BN, Roy T, Homesley H, Lee RB, Gehrig PA, Zaino R. Adjuvant whole abdominal irradiation in clinical stages I and II papillary serous or clear cell carcinoma of the endometrium: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Feb;100(2):349-54. doi: 10.1016/j.ygyno.2005.08.037. Epub 2005 Oct 5.
- Carey MS, O'Connell GJ, Johanson CR, Goodyear MD, Murphy KJ, Daya DM, Schepansky A, Peloquin A, Lumsden BJ. Good outcome associated with a standardized treatment protocol using selective postoperative radiation in patients with clinical stage I adenocarcinoma of the endometrium. Gynecol Oncol. 1995 May;57(2):138-44. doi: 10.1006/gyno.1995.1115.
- Greven KM, Randall M, Fanning J, Bahktar M, Duray P, Peters A, Curran WJ Jr. Patterns of failure in patients with stage I, grade 3 carcinoma of the endometrium. Int J Radiat Oncol Biol Phys. 1990 Sep;19(3):529-34. doi: 10.1016/0360-3016(90)90477-2.
- Ball HG, Blessing JA, Lentz SS, Mutch DG. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996 Aug;62(2):278-81. doi: 10.1006/gyno.1996.0227.
- Moore KN, Fader AN. Uterine papillary serous carcinoma. Clin Obstet Gynecol. 2011 Jun;54(2):278-91. doi: 10.1097/GRF.0b013e318218c755.
- Grigsby PW, Perez CA, Camel HM, Kao MS, Galakatos AE. Stage II carcinoma of the endometrium: results of therapy and prognostic factors. Int J Radiat Oncol Biol Phys. 1985 Nov;11(11):1915-23. doi: 10.1016/0360-3016(85)90272-x.
- Sherman ME, Devesa SS. Analysis of racial differences in incidence, survival, and mortality for malignant tumors of the uterine corpus. Cancer. 2003 Jul 1;98(1):176-86. doi: 10.1002/cncr.11484.
- Greven KM, Curran WJ Jr, Whittington R, Fanning J, Randall ME, Wilder J, Peters AJ. Analysis of failure patterns in stage III endometrial carcinoma and therapeutic implications. Int J Radiat Oncol Biol Phys. 1989 Jul;17(1):35-9. doi: 10.1016/0360-3016(89)90367-2.
- Calais G, Vitu L, Descamps P, Body G, Reynaud-Bougnoux A, Lansac J, Bougnoux P, Le Floch O. Preoperative or postoperative brachytherapy for patients with endometrial carcinoma stage I and II. Int J Radiat Oncol Biol Phys. 1990 Sep;19(3):523-7. doi: 10.1016/0360-3016(90)90476-z.
- Lanciano RM, Curran WJ Jr, Greven KM, Fanning J, Stafford P, Randall ME, Hanks GE. Influence of grade, histologic subtype, and timing of radiotherapy on outcome among patients with stage II carcinoma of the endometrium. Gynecol Oncol. 1990 Dec;39(3):368-73. doi: 10.1016/0090-8258(90)90268-p.
- Kato DT, Ferry JA, Goodman A, Sullinger J, Scully RE, Goff BA, Fuller AF Jr, Rice LW. Uterine papillary serous carcinoma (UPSC): a clinicopathologic study of 30 cases. Gynecol Oncol. 1995 Dec;59(3):384-9. doi: 10.1006/gyno.1995.9957.
- Smith RS, Kapp DS, Chen Q, Teng NN. Treatment of high-risk uterine cancer with whole abdominopelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2000 Oct 1;48(3):767-78. doi: 10.1016/s0360-3016(00)00724-0.
- Mackillop WJ, Pringle JF. Stage III endometrial carcinoma. A review of 90 cases. Cancer. 1985 Nov 15;56(10):2519-23. doi: 10.1002/1097-0142(19851115)56:103.0.co;2-m.
- Elliott P, Green D, Coates A, Krieger M, Russell P, Coppleson M, Solomon J, Tattersall M. The efficacy of postoperative vaginal irradiation in preventing vaginal recurrence in endometrial cancer. Int J Gynecol Cancer. 1994 Mar;4(2):84-93. doi: 10.1046/j.1525-1438.1994.04020084.x.
- Goff BA, Kato D, Schmidt RA, Ek M, Ferry JA, Muntz HG, Cain JM, Tamimi HK, Figge DC, Greer BE. Uterine papillary serous carcinoma: patterns of metastatic spread. Gynecol Oncol. 1994 Sep;54(3):264-8. doi: 10.1006/gyno.1994.1208.
- Randall ME, Wilder J, Greven K, Raben M. Role of intracavitary cuff boost after adjuvant external irradiation in early endometrial carcinoma. Int J Radiat Oncol Biol Phys. 1990 Jul;19(1):49-54. doi: 10.1016/0360-3016(90)90133-5.
- O'Hanlan KA, Levine PA, Harbatkin D, Feiner C, Goldberg GL, Jones JG, Rodriguez-Rodriguez L. Virulence of papillary endometrial carcinoma. Gynecol Oncol. 1990 Apr;37(1):112-9. doi: 10.1016/0090-8258(90)90318-f.
- Abeler VM, Vergote IB, Kjorstad KE, Trope CG. Clear cell carcinoma of the endometrium. Prognosis and metastatic pattern. Cancer. 1996 Oct 15;78(8):1740-7. doi: 10.1002/(sici)1097-0142(19961015)78:83.0.co;2-y.
- Karin Shih 2020. "Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04030000.
Frequently Asked Questions
Does this research project allow elderly individuals to participate?
"In order to be included in this clinical trial, patients must be aged 18 to 99. Out of the 3735 total trials, 151 are for people under 18 and 3735 are for patients over 65." - Anonymous Online Contributor
Unverified Answer
Are we able to sign people up for this trial at the moment?
"The information available on clinicaltrials.gov does specify that this trial is open and recruiting patients. This particular trial was first posted on May 20th, 2020 with the most recent update being November 16th, 2021. So far, only 17 individuals have been enrolled at a single site." - Anonymous Online Contributor
Unverified Answer
Could you tell me how many people are involved in this clinical trial?
"Yes, the clinicaltrial.gov website verifies that this trial is still actively searching for participants. The posting date was May 20th 2020 with the most recent update on November 16th 2021. They are hoping to enroll 17 subjects from a single location." - Anonymous Online Contributor
Unverified Answer
Is this treatment backed by other scientific research?
"There are currently 1229 trials studying this treatment with 343 of them being in Phase 3. The majority of these clinical studies are based in Shanghai, but there are 67003 locations running trials for this treatment." - Anonymous Online Contributor
Unverified Answer
Are there any medical prerequisites for this clinical study?
"Carcinoma patients between the ages of 18 and 99 are encouraged to apply for this clinical trial. In addition to carcinoma, eligible patients must also have definitive USC diagnosis determined by a previous procedure. At the discretion of the surgeon, complete surgical staging should include: total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, omental biopsy and lymph node evaluation., ECOG performance status of ≤ 2., Residual disease at completion of surgery of ≤ 1cm by surgeon report., Age > 18 years.." - Anonymous Online Contributor
Unverified Answer