Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT03729518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-11-01', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year locoregional control', 'timeFrame': '2 years', 'description': 'Number of patients with 2-year locoregional control, defined as control at the primary site and in the neck, in patients undergoing de-intensified radiation to the primary site and regional lymphatics after Transoral Robotic Surgery (TORS) and neck dissection for p16+ oropharyngeal squamous cell carcinoma (OPSCC)'}], 'secondaryOutcomes': [{'measure': 'Treatment-related toxicity', 'timeFrame': '2 years', 'description': 'Number of participants with treatment-related toxicity as gauged by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. the CTCAE v.5 utilizes a five point scale to report Adverse Events (AEs), defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure (cancer.gov)'}, {'measure': '2-year progression-free survival', 'timeFrame': '3 years', 'description': 'Number of participants with 2-year progression-free survival, defined as the length of time during and after treatment that a patient lives with the disease but it does not get worse (nih.gov)'}, {'measure': 'Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)', 'timeFrame': '1 year', 'description': 'Differences in toxicity outcomes in patients treated with IMRT versus proton therapy'}, {'measure': 'Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment', 'timeFrame': '2 years', 'description': 'Number of patients with a change in circulating HPV cells during the course of treatment, determined using a next generation sequencing (NGS) assay developed to detect HPV DNA in HPV+ oropharyngeal squamous cell carcinoma patients.'}, {'measure': 'Metastasis-free survival', 'timeFrame': '3 years', 'description': 'Number of participants with metastasis-free survival'}, {'measure': 'Patient reported quality of life outcomes', 'timeFrame': '2.5 years', 'description': 'Patient reported quality of life (QOL) outcomes using MD Anderson Symptom Inventory (MDASI) Head and Neck survey between patients treated with IMRT and IMPT. The MDASI-HN assesses the severity of symptoms in the last 24 hours using a 0-10 scale, with 0 being "not present" and 10 being "as bad as you can imagine". The interference of symptoms in the last 24 hours is assessed using a 0-10 scale, with 0 being "did not interfere" and 10 being "interfered completely". The mean of symptom severity and interference can be used to represent overall symptom distress and can be analyzed for changes over treatment and during follow-up.'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Number of patients with overall survival, as defined by the length of time from the date of diagnosis or start of treatment for a disease that patients diagnosed with the disease are still alive (cancer.gov)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oropharyngeal Cancer', 'Squamous Cell Carcinoma', 'Human Papilloma Virus']}, 'referencesModule': {'references': [{'pmid': '21079160', 'type': 'BACKGROUND', 'citation': "Weinstein GS, O'Malley BW Jr, Cohen MA, Quon H. Transoral robotic surgery for advanced oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Nov;136(11):1079-85. doi: 10.1001/archoto.2010.191."}, {'pmid': '20717944', 'type': 'BACKGROUND', 'citation': "Weinstein GS, Quon H, O'Malley BW Jr, Kim GG, Cohen MA. Selective neck dissection and deintensified postoperative radiation and chemotherapy for oropharyngeal cancer: a subset analysis of the University of Pennsylvania transoral robotic surgery trial. Laryngoscope. 2010 Sep;120(9):1749-55. doi: 10.1002/lary.21021."}, {'pmid': '20530316', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23295795', 'type': 'BACKGROUND', 'citation': "O'Sullivan B, Huang SH, Siu LL, Waldron J, Zhao H, Perez-Ordonez B, Weinreb I, Kim J, Ringash J, Bayley A, Dawson LA, Hope A, Cho J, Irish J, Gilbert R, Gullane P, Hui A, Liu FF, Chen E, Xu W. Deintensification candidate subgroups in human papillomavirus-related oropharyngeal cancer according to minimal risk of distant metastasis. J Clin Oncol. 2013 Feb 10;31(5):543-50. doi: 10.1200/JCO.2012.44.0164. Epub 2013 Jan 7."}, {'pmid': '21425382', 'type': 'BACKGROUND', 'citation': "Cohen MA, Weinstein GS, O'Malley BW Jr, Feldman M, Quon H. Transoral robotic surgery and human papillomavirus status: Oncologic results. Head Neck. 2011 Apr;33(4):573-80. doi: 10.1002/hed.21500. Epub 2010 Dec 6."}, {'pmid': '22588642', 'type': 'BACKGROUND', 'citation': "Quon H, Cohen MA, Montone KT, Ziober AF, Wang LP, Weinstein GS, O'Malley BW Jr. Transoral robotic surgery and adjuvant therapy for oropharyngeal carcinomas and the influence of p16 INK4a on treatment outcomes. Laryngoscope. 2013 Mar;123(3):635-40. doi: 10.1002/lary.22172. Epub 2013 Feb 1."}, {'pmid': '20946673', 'type': 'BACKGROUND', 'citation': 'Ingle CJ, Yip K, Caskie V, Dyson C, Ford A, Scrase CD. Intensity modulated radiotherapy (IMRT) in the management of locally advanced oropharyngeal squamous cell carcinomata (SCC): disease control and functional outcome using the therapy outcome measure (TOM) score--report from a single U.K. institution. Head Neck Oncol. 2010 Oct 14;2:28. doi: 10.1186/1758-3284-2-28.'}, {'pmid': '24928257', 'type': 'BACKGROUND', 'citation': "Lukens JN, Lin A, Gamerman V, Mitra N, Grover S, McMenamin EM, Weinstein GS, O'Malley BW Jr, Cohen RB, Orisamolu A, Ahn PH, Quon H. Late consequential surgical bed soft tissue necrosis in advanced oropharyngeal squamous cell carcinomas treated with transoral robotic surgery and postoperative radiation therapy. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):981-988. doi: 10.1016/j.ijrobp.2014.04.024. Epub 2014 Jun 10."}, {'pmid': '22801885', 'type': 'BACKGROUND', 'citation': "Weinstein GS, Quon H, Newman HJ, Chalian JA, Malloy K, Lin A, Desai A, Livolsi VA, Montone KT, Cohen KR, O'Malley BW. Transoral robotic surgery alone for oropharyngeal cancer: an analysis of local control. Arch Otolaryngol Head Neck Surg. 2012 Jul;138(7):628-34. doi: 10.1001/archoto.2012.1166."}, {'pmid': '28094210', 'type': 'BACKGROUND', 'citation': "Ojerholm E, Lukens JN, Ahn PH, Geiger G, Swisher-McClure S, Newman J, Chalian A, Weinstein G, O'Malley BW Jr, Cohen R, Lin A. Benefits of omitting primary site radiation therapy after transoral robotic surgery: Only time will tell. Pract Radiat Oncol. 2017 May-Jun;7(3):e157-e158. doi: 10.1016/j.prro.2016.10.019. Epub 2016 Nov 4. No abstract available."}, {'pmid': '28056518', 'type': 'BACKGROUND', 'citation': 'Gamez ME, Halyard MY, Hinni ML, Hayden RE, Nagel TH, Vargas CE, Wong WW, Curtis KK, Zarka MA, Ma D, Patel SH. Mucosal Sparing Radiation Therapy in Resected Oropharyngeal Cancer. Ann Otol Rhinol Laryngol. 2017 Mar;126(3):185-191. doi: 10.1177/0003489416681580. Epub 2017 Jan 5.'}, {'pmid': '29722676', 'type': 'BACKGROUND', 'citation': 'Erratum to: Routman DM, Funk RK, Tangsriwong K, et al. Relapse rates with surgery alone in human papillomavirus-related intermediate- and high-risk group oropharynx squamous cell cancer: A multi-institutional review. Int J Radiat Oncol Biol Phys 2017;99:938-946. Int J Radiat Oncol Biol Phys. 2018 Apr 1;100(5):1304. doi: 10.1016/j.ijrobp.2017.12.286. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'ClinicalTrials.gov. Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS).'}, {'pmid': '28434660', 'type': 'BACKGROUND', 'citation': 'Chen AM, Felix C, Wang PC, Hsu S, Basehart V, Garst J, Beron P, Wong D, Rosove MH, Rao S, Melanson H, Kim E, Palmer D, Qi L, Kelly K, Steinberg ML, Kupelian PA, Daly ME. Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study. Lancet Oncol. 2017 Jun;18(6):803-811. doi: 10.1016/S1470-2045(17)30246-2. Epub 2017 Apr 20.'}, {'pmid': '28258895', 'type': 'BACKGROUND', 'citation': "Huang SH, Waldron J, Bratman SV, Su J, Kim J, Bayley A, Cho J, Giuliani M, Hope A, Ringash J, Hansen A, de Almeida JR, Goldstein D, Perez-Ordonez B, Weinreb I, Tong L, Xu W, O'Sullivan B. Re-evaluation of Ipsilateral Radiation for T1-T2N0-N2b Tonsil Carcinoma at the Princess Margaret Hospital in the Human Papillomavirus Era, 25 Years Later. Int J Radiat Oncol Biol Phys. 2017 May 1;98(1):159-169. doi: 10.1016/j.ijrobp.2017.01.018. Epub 2017 Jan 9."}, {'pmid': '22250010', 'type': 'BACKGROUND', 'citation': 'Expert Panel on Radiation Oncology--Head & Neck Cancer:; Yeung AR, Garg MK, Lawson J, McDonald MW, Quon H, Ridge JA, Saba N, Salama JK, Smith RV, Yom SS, Beitler JJ; American College of Radiology. ACR Appropriateness Criteria(R) ipsilateral radiation for squamous cell carcinoma of the tonsil. Head Neck. 2012 May;34(5):613-6. doi: 10.1002/hed.21993. Epub 2012 Jan 17.'}, {'pmid': '23386545', 'type': 'BACKGROUND', 'citation': 'Liu C, Corry J, Peters L. Letter to the editor regarding ACR Appropriateness Criteria for ipsilateral radiation for squamous cell carcinoma of the tonsil. Head Neck. 2013 Mar;35(3):464. doi: 10.1002/hed.23207. Epub 2013 Feb 5. No abstract available.'}, {'pmid': '23729387', 'type': 'BACKGROUND', 'citation': 'Liu C, Dutu G, Peters LJ, Rischin D, Corry J. 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Epub 2016 Sep 24.'}, {'pmid': '25320012', 'type': 'BACKGROUND', 'citation': 'Parikh F, Duluc D, Imai N, Clark A, Misiukiewicz K, Bonomi M, Gupta V, Patsias A, Parides M, Demicco EG, Zhang DY, Kim-Schulze S, Kao J, Gnjatic S, Oh S, Posner MR, Sikora AG. Chemoradiotherapy-induced upregulation of PD-1 antagonizes immunity to HPV-related oropharyngeal cancer. Cancer Res. 2014 Dec 15;74(24):7205-16. doi: 10.1158/0008-5472.CAN-14-1913. Epub 2014 Oct 15.'}, {'pmid': '28397821', 'type': 'BACKGROUND', 'citation': "Huang AC, Postow MA, Orlowski RJ, Mick R, Bengsch B, Manne S, Xu W, Harmon S, Giles JR, Wenz B, Adamow M, Kuk D, Panageas KS, Carrera C, Wong P, Quagliarello F, Wubbenhorst B, D'Andrea K, Pauken KE, Herati RS, Staupe RP, Schenkel JM, McGettigan S, Kothari S, George SM, Vonderheide RH, Amaravadi RK, Karakousis GC, Schuchter LM, Xu X, Nathanson KL, Wolchok JD, Gangadhar TC, Wherry EJ. T-cell invigoration to tumour burden ratio associated with anti-PD-1 response. Nature. 2017 May 4;545(7652):60-65. doi: 10.1038/nature22079. Epub 2017 Apr 10."}, {'pmid': '28446615', 'type': 'BACKGROUND', 'citation': 'Kamphorst AO, Pillai RN, Yang S, Nasti TH, Akondy RS, Wieland A, Sica GL, Yu K, Koenig L, Patel NT, Behera M, Wu H, McCausland M, Chen Z, Zhang C, Khuri FR, Owonikoko TK, Ahmed R, Ramalingam SS. Proliferation of PD-1+ CD8 T cells in peripheral blood after PD-1-targeted therapy in lung cancer patients. Proc Natl Acad Sci U S A. 2017 May 9;114(19):4993-4998. doi: 10.1073/pnas.1705327114. Epub 2017 Apr 26.'}, {'pmid': '8637047', 'type': 'BACKGROUND', 'citation': 'Tejeda HA, Green SB, Trimble EL, Ford L, High JL, Ungerleider RS, Friedman MA, Brawley OW. Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst. 1996 Jun 19;88(12):812-6. doi: 10.1093/jnci/88.12.812.'}, {'pmid': '15510014', 'type': 'BACKGROUND', 'citation': 'Sikora AG, Toniolo P, DeLacure MD. The changing demographics of head and neck squamous cell carcinoma in the United States. Laryngoscope. 2004 Nov;114(11):1915-23. doi: 10.1097/01.mlg.0000147920.66486.bc.'}, {'type': 'BACKGROUND', 'citation': 'Society AC. Cancer Facts and Figures 2011. 2011.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.', 'detailedDescription': 'This is a single arm Phase II study of adjuvant radiation for locally-advanced p16+ oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N2b, M0 disease (per AJCC 7th ed) with \\<5 positive lymph nodes, will be eligible. Patients will have undergone TORS primary site resection and ipsilateral neck dissection. Patients will undergo radiation dose reduction and target volume reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>= 18 years old\n* Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry\n* Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 7th Ed)\n* Pathologic N0, N1, N2a, or N2b disease (per AJCC 7th Ed), with \\< 5 positive lymph nodes\n* ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Prior radiation therapy to the head and neck\n* Presence of T4 disease\n* Presence of N2c or N3 neck disease (per AJCC 7th Ed)\n* \\>= 5 lymph nodes\n* Presence of distant metastatic disease'}, 'identificationModule': {'nctId': 'NCT03729518', 'briefTitle': 'TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'UPCC 15318'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.', 'interventionNames': ['Radiation: Radiation Therapy (IMRT or IMPT)']}], 'interventions': [{'name': 'Radiation Therapy (IMRT or IMPT)', 'type': 'RADIATION', 'description': '* Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In those patients requiring treatment of the primary site, reduced dose (50 Gy) will be delivered.\n* Receipt of concurrent chemotherapy per current guidelines. Chemotherapy may be omitted in patients with focal or microscopic ENE (defined as ≤ 1 mm ENE), at the discretion of the treating Medical Oncologist.\n* Blood samples will be obtained at time of enrollment, and at two time points during RT, to quantify circulating HPV DNA and perform immune profiling.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}