Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer

Summary

This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes.

Timeline

Start

2020-07-15

Primary completion

2025-01-31

Completion

2025-01-31

Outcome

Outcome not reported

Stopped (Enrollment): “The study is discontinued because of recruitment failure, and for strategic reason (competitive trials with immunotherapy)”

Publications

• Background Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH; ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006 Dec;100(3):255-62. doi: 10.1007/s10549-006-9254-4. Epub 2006 May 17.
• Background Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.
• Background Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6.
• Background Leblanc E, Narducci F, Frumovitz M, Lesoin A, Castelain B, Baranzelli MC, Taieb S, Fournier C, Querleu D. Therapeutic value of pretherapeutic extraperitoneal laparoscopic staging of locally advanced cervical carcinoma. Gynecol Oncol. 2007 May;105(2):304-11. doi: 10.1016/j.ygyno.2006.12.012. Epub 2007 Jan 29.
• Background Grigsby PW. The prognostic value of PET and PET/CT in cervical cancer. Cancer Imaging. 2008 Jul 24;8(1):146-55. doi: 10.1102/1470-7330.2008.0022.
• Background Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.
• Background Ahmed RS, Kim RY, Duan J, Meleth S, De Los Santos JF, Fiveash JB. IMRT dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):505-12. doi: 10.1016/j.ijrobp.2004.03.035.
• Background Rotman M, Pajak TF, Choi K, Clery M, Marcial V, Grigsby PW, Cooper J, John M. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA. 1995 Aug 2;274(5):387-93.
• Background Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004 Mar 1;22(5):872-80. doi: 10.1200/JCO.2004.07.197.
• Background Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
• Background Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7. doi: 10.1016/s0360-3016(01)01723-0.
• Background Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1354-60. doi: 10.1016/s0360-3016(03)00325-0.
• Background Cihoric N, Tapia C, Kruger K, Aebersold DM, Klaeser B, Lossl K. IMRT with (1)(8)FDG-PET\CT based simultaneous integrated boost for treatment of nodal positive cervical cancer. Radiat Oncol. 2014 Mar 25;9:83. doi: 10.1186/1748-717X-9-83.
• Background Vargo JA, Kim H, Choi S, Sukumvanich P, Olawaiye AB, Kelley JL, Edwards RP, Comerci JT, Beriwal S. Extended field intensity modulated radiation therapy with concomitant boost for lymph node-positive cervical cancer: analysis of regional control and recurrence patterns in the positron emission tomography/computed tomography era. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1091-8. doi: 10.1016/j.ijrobp.2014.08.013. Epub 2014 Oct 8.
• Background Perry LJ, Mathews C, Nugent E, Farrell R, Zorn K, Moore K. Outcomes of cervical cancer and positive para-aortic lymph nodes in the modern era of chemoradiation. Int J Gynecol Cancer. 2014 Mar;24(3):564-9. doi: 10.1097/IGC.0000000000000093.
• Background Gouy S, Morice P, Narducci F, Uzan C, Martinez A, Rey A, Bentivegna E, Pautier P, Deandreis D, Querleu D, Haie-Meder C, Leblanc E. Prospective multicenter study evaluating the survival of patients with locally advanced cervical cancer undergoing laparoscopic para-aortic lymphadenectomy before chemoradiotherapy in the era of positron emission tomography imaging. J Clin Oncol. 2013 Aug 20;31(24):3026-33. doi: 10.1200/JCO.2012.47.3520. Epub 2013 Jul 15.
• Background Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.
• Background Mabuchi S, Morishige K, Fujita M, Tsutsui T, Sakata M, Enomoto T, Kimura T. The activity of carboplatin and paclitaxel for recurrent cervical cancer after definitive radiotherapy. Gynecol Oncol. 2009 May;113(2):200-4. doi: 10.1016/j.ygyno.2009.02.008. Epub 2009 Mar 6.
• Background Tinker AV, Bhagat K, Swenerton KD, Hoskins PJ. Carboplatin and paclitaxel for advanced and recurrent cervical carcinoma: the British Columbia Cancer Agency experience. Gynecol Oncol. 2005 Jul;98(1):54-8. doi: 10.1016/j.ygyno.2005.03.037.
• Background Mabuchi S, Morishige K, Enomoto T, Kimura T. Carboplatin and paclitaxel as an initial treatment in patients with stage IVb cervical cancer: a report of 7 cases and a review of the literature. J Gynecol Oncol. 2010 Jun;21(2):93-6. doi: 10.3802/jgo.2010.21.2.93. Epub 2010 Jun 30.
• Background Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials. Eur J Cancer. 2003 Nov;39(17):2470-86. doi: 10.1016/s0959-8049(03)00425-8.
• Background McCormack M, Kadalayil L, Hackshaw A, Hall-Craggs MA, Symonds RP, Warwick V, Simonds H, Fernando I, Hammond M, James L, Feeney A, Ledermann JA. A phase II study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer. Br J Cancer. 2013 Jun 25;108(12):2464-9. doi: 10.1038/bjc.2013.230. Epub 2013 May 21.
• Background Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008 Apr 17;358(16):1663-71. doi: 10.1056/NEJMoa0707056.
• Background ELLIS RE. The distribution of active bone marrow in the adult. Phys Med Biol. 1961 Jan;5:255-8. doi: 10.1088/0031-9155/5/3/302. No abstract available.
• Background Vande Berg BC, Malghem J, Lecouvet FE, Maldague B. Magnetic resonance imaging of the normal bone marrow. Skeletal Radiol. 1998 Sep;27(9):471-83. doi: 10.1007/s002560050423.
• Background Platta CS, Bayliss A, McHaffie D, Tome WA, Straub MR, Bradley KA. A dosimetric analysis of tomotherapy based intensity modulated radiation therapy with and without bone marrow sparing in gynecologic malignancies. Technol Cancer Res Treat. 2013 Feb;12(1):19-29. doi: 10.7785/tcrt.2012.500300. Epub 2012 Sep 10.
• Background Mell LK, Kochanski JD, Roeske JC, Haslam JJ, Mehta N, Yamada SD, Hurteau JA, Collins YC, Lengyel E, Mundt AJ. Dosimetric predictors of acute hematologic toxicity in cervical cancer patients treated with concurrent cisplatin and intensity-modulated pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Dec 1;66(5):1356-65. doi: 10.1016/j.ijrobp.2006.03.018. Epub 2006 Jun 6.
• Background Chang Y, Yang ZY, Li GL, Li Q, Yang Q, Fan JQ, Zhao YC, Song YQ, Wu G. Correlations Between Radiation Dose in Bone Marrow and Hematological Toxicity in Patients With Cervical Cancer: A Comparison of 3DCRT, IMRT, and RapidARC. Int J Gynecol Cancer. 2016 May;26(4):770-6. doi: 10.1097/IGC.0000000000000660.
• Background Yang TJ, Oh JH, Apte A, Son CH, Deasy JO, Goodman KA. Clinical and dosimetric predictors of acute hematologic toxicity in rectal cancer patients undergoing chemoradiotherapy. Radiother Oncol. 2014 Oct;113(1):29-34. doi: 10.1016/j.radonc.2014.09.002. Epub 2014 Oct 7.
• Background Lujan AE, Mundt AJ, Yamada SD, Rotmensch J, Roeske JC. Intensity-modulated radiotherapy as a means of reducing dose to bone marrow in gynecologic patients receiving whole pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):516-21. doi: 10.1016/s0360-3016(03)00521-2.
• Background Lim K, Small W Jr, Portelance L, Creutzberg C, Jurgenliemk-Schulz IM, Mundt A, Mell LK, Mayr N, Viswanathan A, Jhingran A, Erickson B, De los Santos J, Gaffney D, Yashar C, Beriwal S, Wolfson A, Taylor A, Bosch W, El Naqa I, Fyles A; Gyn IMRT Consortium. Consensus guidelines for delineation of clinical target volume for intensity-modulated pelvic radiotherapy for the definitive treatment of cervix cancer. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):348-55. doi: 10.1016/j.ijrobp.2009.10.075. Epub 2010 May 14.
• Background A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

Drugs

Indications