drugset / Trial / NCT05144100
Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II/III Integrated Design Randomized Control Trial
Phase 2/3
Not yet recruiting
498 enrolled
Tata Memorial Centre
All India Institute of Medical Sciences · collabAmrita Institute of Medical Sciences & Research Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The oropharyngeal areas mainly comprises of the tonsil, base tongue (BOT), soft palate and the posterior pharyngeal wall. Traditionally, surgical resection of oropharyngeal cancers (OPC) was a standard procedure, often performed through mutilating incisions with mandibulotomies, rendering significant post-operative functional deficits. Over the past 2 decades, there has been a major shift in treatment strategy with a majority of these cancers now being treated by primary concurrent chemoradiation (CCRT) with a trend towards organ and function preservation.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2029-06-30
- Completion
- 2031-06-30
Publications
- Results Holsinger FC, Weber RS. Swing of the surgical pendulum: a return to surgery for treatment of head and neck cancer in the 21st century? Int J Radiat Oncol Biol Phys. 2007;69(2 Suppl):S129-31. doi: 10.1016/j.ijrobp.2007.05.044.
- Results WARD GE, ROBBEN JO. A composite operation for radical neck dissection and removal of cancer of the mouth. Cancer. 1951 Jan;4(1):98-109. doi: 10.1002/1097-0142(195101)4:13.0.co;2-r. No abstract available.
- Results Golusinski W, Golusinska-Kardach E. Current Role of Surgery in the Management of Oropharyngeal Cancer. Front Oncol. 2019 May 24;9:388. doi: 10.3389/fonc.2019.00388. eCollection 2019.
- Results Ang KK, Harris J, Wheeler R, Weber R, Rosenthal DI, Nguyen-Tan PF, Westra WH, Chung CH, Jordan RC, Lu C, Kim H, Axelrod R, Silverman CC, Redmond KP, Gillison ML. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med. 2010 Jul 1;363(1):24-35. doi: 10.1056/NEJMoa0912217. Epub 2010 Jun 7.
- Results Adelstein DJ, Ismaila N, Ku JA, Burtness B, Swiecicki PL, Mell L, Beitler JJ, Gross N, Jones CU, Kaufman M, Le QT, Semrad TJ, Siu LL, Ridge JA. Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer: ASCO Provisional Clinical Opinion. J Clin Oncol. 2019 Jun 20;37(18):1578-1589. doi: 10.1200/JCO.19.00441. Epub 2019 Apr 25.
- Results Kano S, Homma A, Hayashi R, Kawabata K, Yoshino K, Iwae S, Hasegawa Y, Nibu K, Kato T, Shiga K, Matsuura K, Monden N, Fujii M. Salvage surgery for recurrent oropharyngeal cancer after chemoradiotherapy. Int J Clin Oncol. 2013 Oct;18(5):817-23. doi: 10.1007/s10147-012-0449-x. Epub 2012 Jul 25.
- Results Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
- Results Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, Glisson B, Trotti A, Ridge JA, Chao C, Peters G, Lee DJ, Leaf A, Ensley J, Cooper J. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003 Nov 27;349(22):2091-8. doi: 10.1056/NEJMoa031317.
- Results Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 26.
- Results Posner MR, Hershock DM, Blajman CR, Mickiewicz E, Winquist E, Gorbounova V, Tjulandin S, Shin DM, Cullen K, Ervin TJ, Murphy BA, Raez LE, Cohen RB, Spaulding M, Tishler RB, Roth B, Viroglio Rdel C, Venkatesan V, Romanov I, Agarwala S, Harter KW, Dugan M, Cmelak A, Markoe AM, Read PW, Steinbrenner L, Colevas AD, Norris CM Jr, Haddad RI; TAX 324 Study Group. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1705-15. doi: 10.1056/NEJMoa070956.
- Results Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.
- Results Holsinger FC, Sweeney AD, Jantharapattana K, Salem A, Weber RS, Chung WY, Lewis CM, Grant DG. The emergence of endoscopic head and neck surgery. Curr Oncol Rep. 2010 May;12(3):216-22. doi: 10.1007/s11912-010-0097-0.
- Results McGregor IA, MacDonald DG. Mandibular osteotomy in the surgical approach to the oral cavity. Head Neck Surg. 1983 May-Jun;5(5):457-62. doi: 10.1002/hed.2890050512.
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- Results Singh AM, Bahadur S, Tandon DA, Pande RM. Anterior mandibulotomy for oral and oropharyngeal tumours. J Laryngol Otol. 1993 Apr;107(4):316-9. doi: 10.1017/s0022215100122911.
- Results Roux M, Dassonville O, Ettaiche M, Poissonnet G, Sudaka A, Bozec A. Transoral-transcervical oropharyngectomy without mandibulotomy, associated to fasciocutaneous radial forearm free-flap reconstruction, for oropharyngeal cancer: Postoperative course, oncologic and functional results, and prognostic factors. Eur Ann Otorhinolaryngol Head Neck Dis. 2017 Apr;134(2):71-76. doi: 10.1016/j.anorl.2016.11.004. Epub 2016 Nov 30.
- Results Na HY, Choi EJ, Choi EC, Kim HJ, Cha IH, Nam W. Modified mandibulotomy technique to reduce postoperative complications: 5-year results. Yonsei Med J. 2013 Sep;54(5):1248-52. doi: 10.3349/ymj.2013.54.5.1248.
- Results Sinclair CF, McColloch NL, Carroll WR, Rosenthal EL, Desmond RA, Magnuson JS. Patient-perceived and objective functional outcomes following transoral robotic surgery for early oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2011 Nov;137(11):1112-6. doi: 10.1001/archoto.2011.172.
- Results Hurtuk AM, Marcinow A, Agrawal A, Old M, Teknos TN, Ozer E. Quality-of-life outcomes in transoral robotic surgery. Otolaryngol Head Neck Surg. 2012 Jan;146(1):68-73. doi: 10.1177/0194599811421298. Epub 2011 Aug 31.
- Results Francis DO, Weymuller EA Jr, Parvathaneni U, Merati AL, Yueh B. Dysphagia, stricture, and pneumonia in head and neck cancer patients: does treatment modality matter? Ann Otol Rhinol Laryngol. 2010 Jun;119(6):391-7. doi: 10.1177/000348941011900605.
- Results Weinstein GS, O'Malley BW Jr, Desai SC, Quon H. Transoral robotic surgery: does the ends justify the means? Curr Opin Otolaryngol Head Neck Surg. 2009 Apr;17(2):126-31. doi: 10.1097/MOO.0b013e32832924f5.
- Results Nichols AC, Theurer J, Prisman E, Read N, Berthelet E, Tran E, Fung K, de Almeida JR, Bayley A, Goldstein DP, Hier M, Sultanem K, Richardson K, Mlynarek A, Krishnan S, Le H, Yoo J, MacNeil SD, Winquist E, Hammond JA, Venkatesan V, Kuruvilla S, Warner A, Mitchell S, Chen J, Corsten M, Johnson-Obaseki S, Eapen L, Odell M, Parker C, Wehrli B, Kwan K, Palma DA. Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial. Lancet Oncol. 2019 Oct;20(10):1349-1359. doi: 10.1016/S1470-2045(19)30410-3. Epub 2019 Aug 12.
- Results Eisbruch A, Lyden T, Bradford CR, Dawson LA, Haxer MJ, Miller AE, Teknos TN, Chepeha DB, Hogikyan ND, Terrell JE, Wolf GT. Objective assessment of swallowing dysfunction and aspiration after radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):23-8. doi: 10.1016/s0360-3016(02)02712-8.
- Results Hunter KU, Schipper M, Feng FY, Lyden T, Haxer M, Murdoch-Kinch CA, Cornwall B, Lee CS, Chepeha DB, Eisbruch A. Toxicities affecting quality of life after chemo-IMRT of oropharyngeal cancer: prospective study of patient-reported, observer-rated, and objective outcomes. Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):935-40. doi: 10.1016/j.ijrobp.2012.08.030. Epub 2012 Oct 3.
- Results de Almeida JR, Byrd JK, Wu R, Stucken CL, Duvvuri U, Goldstein DP, Miles BA, Teng MS, Gupta V, Genden EM. A systematic review of transoral robotic surgery and radiotherapy for early oropharynx cancer: a systematic review. Laryngoscope. 2014 Sep;124(9):2096-102. doi: 10.1002/lary.24712. Epub 2014 May 27.
- Results Yeh DH, Tam S, Fung K, MacNeil SD, Yoo J, Winquist E, Palma DA, Nichols AC. Transoral robotic surgery vs. radiotherapy for management of oropharyngeal squamous cell carcinoma - A systematic review of the literature. Eur J Surg Oncol. 2015 Dec;41(12):1603-14. doi: 10.1016/j.ejso.2015.09.007. Epub 2015 Sep 26.
- Results Housset M, Baillet F, Dessard-Diana B, Martin D, Miglianico L. A retrospective study of three treatment techniques for T1-T2 base of tongue lesions: surgery plus postoperative radiation, external radiation plus interstitial implantation and external radiation alone. Int J Radiat Oncol Biol Phys. 1987 Apr;13(4):511-6. doi: 10.1016/0360-3016(87)90065-4.
- Results Sessions DG, Lenox J, Spector GJ, Chao C, Chaudry OA. Analysis of treatment results for base of tongue cancer. Laryngoscope. 2003 Jul;113(7):1252-61. doi: 10.1097/00005537-200307000-00026.
- Results Weinstein GS, O'Malley BW Jr, Magnuson JS, Carroll WR, Olsen KD, Daio L, Moore EJ, Holsinger FC. Transoral robotic surgery: a multicenter study to assess feasibility, safety, and surgical margins. Laryngoscope. 2012 Aug;122(8):1701-7. doi: 10.1002/lary.23294. Epub 2012 Jul 2.
- Results Ibrahim AS, Civantos FJ, Leibowitz JM, Thomas GR, Arnold DJ, Franzmann EJ, Nicolli EA, Lo K, Nemeth Z, Sargi ZB, Weed DT. Meta-analysis comparing outcomes of different transoral surgical modalities in management of oropharyngeal carcinoma. Head Neck. 2019 Jun;41(6):1656-1666. doi: 10.1002/hed.25647. Epub 2019 Jan 28.
- Results Kamran SC, Qureshi MM, Jalisi S, Salama A, Grillone G, Truong MT. Primary surgery versus primary radiation-based treatment for locally advanced oropharyngeal cancer. Laryngoscope. 2018 Jun;128(6):1353-1364. doi: 10.1002/lary.26903. Epub 2017 Oct 8.
- Results O'Connell D, Seikaly H, Murphy R, Fung C, Cooper T, Knox A, Scrimger R, Harris JR. Primary surgery versus chemoradiotherapy for advanced oropharyngeal cancers: a longitudinal population study. J Otolaryngol Head Neck Surg. 2013 Apr 22;42(1):31. doi: 10.1186/1916-0216-42-31. eCollection 2013.
- Results Stelmes JJ, Gregoire V, Poorten VV, Golusinski W, Szewczyk M, Jones T, Ansarin M, Broglie MA, Giger R, Klussmann JP, Evans M, Bourhis J, Leemans CR, Spriano G, Dietz A, Hunter K, Zimmermann F, Tinhofer I, Patterson JM, Quaglini S, Govaerts AS, Fortpied C, Simon C. Organ Preservation and Late Functional Outcome in Oropharyngeal Carcinoma: Rationale of EORTC 1420, the "Best of" Trial. Front Oncol. 2019 Oct 22;9:999. doi: 10.3389/fonc.2019.00999. eCollection 2019.
- Results Boscolo-Rizzo P, Stellin M, Fuson R, Marchiori C, Gava A, Da Mosto MC. Long-term quality of life after treatment for locally advanced oropharyngeal carcinoma: surgery and postoperative radiotherapy versus concurrent chemoradiation. Oral Oncol. 2009 Nov;45(11):953-7. doi: 10.1016/j.oraloncology.2009.06.005. Epub 2009 Aug 8.
- Results Clark JM, Holmes EM, O'Connell DA, Harris J, Seikaly H, Biron VL. Long-term survival and swallowing outcomes in advanced stage oropharyngeal squamous cell carcinomas. Papillomavirus Res. 2019 Jun;7:1-10. doi: 10.1016/j.pvr.2018.09.002. Epub 2018 Sep 26.
- Results Cano ER, Lai SY, Caylakli F, Johnson JT, Ferris RL, Carrau RL, Snyderman CH, Gooding WE, Simenthal AA Jr, Myers EN. Management of squamous cell carcinoma of the base of tongue with chemoradiation and brachytherapy. Head Neck. 2009 Nov;31(11):1431-8. doi: 10.1002/hed.21111.
- Results Agarwal JP, Mallick I, Bhutani R, Ghosh-Laskar S, Gupta T, Budrukkar A, Murthy V, Sengar M, Dinshaw KA. Prognostic factors in oropharyngeal cancer--analysis of 627 cases receiving definitive radiotherapy. Acta Oncol. 2009;48(7):1026-33. doi: 10.1080/02841860902845839.
- Results Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Results Behera P, Patro BK. Population Based Cancer Registry of India - the Challenges and Opportunities. Asian Pac J Cancer Prev. 2018 Oct 26;19(10):2885-2889. doi: 10.22034/APJCP.2018.19.10.2885.
- Results Robbins KT, Clayman G, Levine PA, Medina J, Sessions R, Shaha A, Som P, Wolf GT; American Head and Neck Society; American Academy of Otolaryngology--Head and Neck Surgery. Neck dissection classification update: revisions proposed by the American Head and Neck Society and the American Academy of Otolaryngology-Head and Neck Surgery. Arch Otolaryngol Head Neck Surg. 2002 Jul;128(7):751-8. doi: 10.1001/archotol.128.7.751. No abstract available.
- Results Koyfman SA, Ismaila N, Crook D, D'Cruz A, Rodriguez CP, Sher DJ, Silbermins D, Sturgis EM, Tsue TT, Weiss J, Yom SS, Holsinger FC. Management of the Neck in Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: ASCO Clinical Practice Guideline. J Clin Oncol. 2019 Jul 10;37(20):1753-1774. doi: 10.1200/JCO.18.01921. Epub 2019 Feb 27.
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- Results Amin MB, Edge S, Greene F, Byrd DR, Brookland RK, Washington MK, et al., editors. AJCC Cancer Staging Manual [Internet]. 8th ed. Springer International Publishing; 2017 [cited 2020 Feb 24].
- Results Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001 Jul;127(7):870-6.
- Results Bjordal K, de Graeff A, Fayers PM, Hammerlid E, van Pottelsberghe C, Curran D, Ahlner-Elmqvist M, Maher EJ, Meyza JW, Bredart A, Soderholm AL, Arraras JJ, Feine JS, Abendstein H, Morton RP, Pignon T, Huguenin P, Bottomly A, Kaasa S. A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group. Eur J Cancer. 2000 Sep;36(14):1796-807. doi: 10.1016/s0959-8049(00)00186-6.
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- Results Martin-Harris B, Brodsky MB, Michel Y, Castell DO, Schleicher M, Sandidge J, Maxwell R, Blair J. MBS measurement tool for swallow impairment--MBSImp: establishing a standard. Dysphagia. 2008 Dec;23(4):392-405. doi: 10.1007/s00455-008-9185-9. Epub 2008 Oct 15.
- Results Noronha V, Patil VM, Joshi A, Mahimkar M, Patel U, Pandey MK, Chandrasekharan A, Dsouza H, Bhattacharjee A, Mahajan A, Sabale N, Agarwal JP, Ghosh-Laskar S, Budrukkar A, D'Cruz AK, Chaturvedi P, Pai PS, Chaukar D, Nair S, Thiagarajan S, Banavali S, Prabhash K. Nimotuzumab-cisplatin-radiation versus cisplatin-radiation in HPV negative oropharyngeal cancer. Oncotarget. 2020 Jan 28;11(4):399-408. doi: 10.18632/oncotarget.27443. eCollection 2020 Jan 28.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |