A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck

NCT04435938 | Unknown Phase 2 DMC

• 1 other identifier: 8134
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the tumour response rate of squamous cell carcinoma of the head and neck following stereotactic body radiotherapy (SBRT) of 45Gy in 5 fractions delivered once every 3-4 days, such that treatment is completed within 15 days.

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma; Squamous Skin Carcinoma

Keywords

Head and Neck Cancer; Squamous Cell Cancer; Squamous Skin Cancer; Stereotactic Body Radiotherapy; SBRT; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Tumour response rate

  Tumour response rate defined as complete or partial response according to Tumour response rate will be defined by RECIST 1.1 criteria

  The best overall response across all time points during the study period - up to 24 months after completion of SBRT.

Secondary Outcomes (3)

• Number of participants with Acute and Late Toxicity

  Up to 24 months after completion of SBRT

• Local Control

  Determination of local recurrence will be based on based on RECIST criteria 1.1 (see section 11.3 below) and assessed on MRI or CT scan imaging at 12 weeks and any additional imaging/clinical assessments performed during the study.

• Quality of Life as measured by the FACT-HN questionnaire

  The FACT-HN Quesionnaire will be administered at Baseline, once during treatment, 6 weeks, 3, 6, 12 months post SBRT treatment. Higher scores represent better qualtiy of life.

Study Arms (1)

Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

The dose prescribed in the study will be 45Gy in 5 fractions, delivered once every 3-4 days, such that treatment is completed within 15 days. (e.g. treatment given on Monday/Thursday/Mon/Thurs/Mon) (Exceptions: treatment duration of up to 18 days will be allowed to account for cancer centre closures and unforeseen patient issues.)

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT) RADIATION

45 Gy in 5 fractions delivered once every 3-4 days

Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 60 years
• Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck region including primary skin SCC; (malignant cells with suspicious/likely SCC will be considered for study if repeat biopsy is not feasible)
• Clinical stage ≥ T2, or any T-stage with N1-N3 disease, M0 or Mx
• Measurable tumour present in the head and neck region on clinical examination and/or imaging at time of study enrollment
• All patients will be assessed by a multi-disciplinary, head and neck oncology team with no systemic therapy being recommended at the time of enrollment
• Primary surgery not recommended/performed due to any of the following:
• Unresectable disease and/or borderline resectable
• Medically inoperable / deemed high risk for post-operative morbidity/mortality by surgical team
• Patient declined surgery
• Deemed not to be a candidate for standard fractionation radiotherapy due to poor performance status and/or medical co-morbidities and/or advanced stage disease
• Eastern Co-operative Oncology Group (ECOG) Performance Status ≤ 3

You may not qualify if:

• Life expectancy ≤ 3 months
• Chemotherapy or other systemic cancer therapy within 3 months prior to HN SBRT
• Basal cell carcinoma, Merkel cell, malignant melanoma, adenocarcinoma are excluded
• HN surgery within 6 months prior to HN SBRT (excision under local anaesthesia is acceptable)
• Prior radiation treatment to the head and neck region (prior radiotherapy to the skin for non-melanoma skin cancer and deemed to have no risk of overlap with the current field are eligible)
• Synchronous or recent cancer diagnosis not including the index cancer (other cancers treated curatively with no evidence of disease for \>=3 years, or other non- melanoma skin cancers treated with no evidence of disease for \>= 6 months are eligible)
• Confirmed or known distant metastatic disease.
• Serious non-malignant disease that precludes definitive radiation treatment (e.g.
• severe cases of scleroderma, systemic lupus erythematosus, rheumatoid arthritis)
• Unable to provide written, informed consent or complete QoL questionnaires and assessments required on the study
• Unable to lie flat for 60 minutes in order to have radiation planning and treatment
• Unable to attend radiation planning and therapy, as well as follow-up care and assessments
• Unable to provide written, informed consent

Sponsors & Collaborators

• McMaster University: lead
• Juravinski Cancer Centre Foundation: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Related Publications (14)

• Eskander A, Krzyzanowska MK, Fischer HD, Liu N, Austin PC, Irish JC, Enepekides DJ, Lee J, Gutierrez E, Lockhart E, Raphael M, Singh S. Emergency department visits and unplanned hospitalizations in the treatment period for head and neck cancer patients treated with curative intent: A population-based analysis. Oral Oncol. 2018 Aug;83:107-114. doi: 10.1016/j.oraloncology.2018.06.011. Epub 2018 Jun 19.

  PMID: 30098764 BACKGROUND

• Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.

  PMID: 19446902 BACKGROUND

• Reid BC, Alberg AJ, Klassen AC, Samet JM, Rozier RG, Garcia I, Winn DM. Comorbidity and survival of elderly head and neck carcinoma patients. Cancer. 2001 Oct 15;92(8):2109-16. doi: 10.1002/1097-0142(20011015)92:83.0.co;2-m.

  PMID: 11596027 BACKGROUND

• Datema FR, Ferrier MB, van der Schroeff MP, Baatenburg de Jong RJ. Impact of comorbidity on short-term mortality and overall survival of head and neck cancer patients. Head Neck. 2010 Jun;32(6):728-36. doi: 10.1002/hed.21245.

  PMID: 19827120 BACKGROUND

• Nguyen NT, Doerwald-Munoz L, Zhang H, Kim DH, Sagar S, Wright JR, Hodson DI. 0-7-21 hypofractionated palliative radiotherapy: an effective treatment for advanced head and neck cancers. Br J Radiol. 2015 May;88(1049):20140646. doi: 10.1259/bjr.20140646. Epub 2015 Feb 19.

  PMID: 25694259 BACKGROUND

• Corry J, Peters LJ, Costa ID, Milner AD, Fawns H, Rischin D, Porceddu S. The 'QUAD SHOT'--a phase II study of palliative radiotherapy for incurable head and neck cancer. Radiother Oncol. 2005 Nov;77(2):137-42. doi: 10.1016/j.radonc.2005.10.008. Epub 2005 Nov 2.

  PMID: 16260054 BACKGROUND

• Stevens CM, Huang SH, Fung S, Bayley AJ, Cho JB, Cummings BJ, Dawson LA, Hope AJ, Kim JJ, O'Sullivan B, Waldron JN, Ringash J. Retrospective study of palliative radiotherapy in newly diagnosed head and neck carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):958-63. doi: 10.1016/j.ijrobp.2010.06.055. Epub 2010 Oct 14.

  PMID: 20950952 BACKGROUND

• Lansbury L, Bath-Hextall F, Perkins W, Stanton W, Leonardi-Bee J. Interventions for non-metastatic squamous cell carcinoma of the skin: systematic review and pooled analysis of observational studies. BMJ. 2013 Nov 4;347:f6153. doi: 10.1136/bmj.f6153.

  PMID: 24191270 BACKGROUND

• Lubeek SF, Borgonjen RJ, van Vugt LJ, Olde Rikkert MG, van de Kerkhof PC, Gerritsen MJ. Improving the applicability of guidelines on nonmelanoma skin cancer in frail older adults: a multidisciplinary expert consensus and systematic review of current guidelines. Br J Dermatol. 2016 Nov;175(5):1003-1010. doi: 10.1111/bjd.14923. Epub 2016 Sep 13.

  PMID: 27484632 BACKGROUND

• Karam I, Yao M, Heron DE, Poon I, Koyfman SA, Yom SS, Siddiqui F, Lartigau E, Cengiz M, Yamazaki H, Hara W, Phan J, Vargo JA, Lee V, Foote RL, Harter KW, Lee NY, Sahgal A, Lo SS. Survey of current practices from the International Stereotactic Body Radiotherapy Consortium (ISBRTC) for head and neck cancers. Future Oncol. 2017 Mar;13(7):603-613. doi: 10.2217/fon-2016-0403. Epub 2016 Nov 15.

  PMID: 27842456 BACKGROUND

• Khan L, Tjong M, Raziee H, Lee J, Erler D, Chin L, Poon I. Role of stereotactic body radiotherapy for symptom control in head and neck cancer patients. Support Care Cancer. 2015 Apr;23(4):1099-103. doi: 10.1007/s00520-014-2421-y. Epub 2014 Oct 9.

  PMID: 25294656 BACKGROUND

• Vargo JA, Ferris RL, Ohr J, Clump DA, Davis KS, Duvvuri U, Kim S, Johnson JT, Bauman JE, Gibson MK, Branstetter BF, Heron DE. A prospective phase 2 trial of reirradiation with stereotactic body radiation therapy plus cetuximab in patients with previously irradiated recurrent squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):480-8. doi: 10.1016/j.ijrobp.2014.11.023. Epub 2015 Jan 30.

  PMID: 25680594 BACKGROUND

• Heron DE, Ferris RL, Karamouzis M, Andrade RS, Deeb EL, Burton S, Gooding WE, Branstetter BF, Mountz JM, Johnson JT, Argiris A, Grandis JR, Lai SY. Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1493-500. doi: 10.1016/j.ijrobp.2008.12.075. Epub 2009 May 21.

  PMID: 19464819 BACKGROUND

• Lee J, Nguyen NT, Wright J, Yeung KD, Sagar S, Kim DH, Ostapiak O, Doerwald-Munoz L, Whelan T. A phase 2 study of stereotactic body radiation therapy for squamous cell carcinoma of the head and neck (SHINE): a single arm clinical trial protocol. BMC Cancer. 2023 Apr 26;23(1):379. doi: 10.1186/s12885-023-10807-4.

  PMID: 37098494 DERIVED

Related Links

• Cancer Statistics. National Cancer Institute.

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Justin Lee, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Chambers, MA

CONTACT

905-387-9711; chamberss@hhsc.ca

Thivya Jeyachanthiran

CONTACT

905-387-9495; jeyachanth@hhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible and consenting patients will be treated with the dose prescribed in the study of 45Gy in 5 fractions, delivered once every 3-4 days, such that treatment is completed within 15 days (Exceptions: treatment duration of up to 18 days will be allowed to account for cancer centre closures and unforeseen patient issues). Using the Simon optimal two-stage design, 11 patients will be recruited in the first stage. If 6 or less patients have a response, the study will be stopped at the end of stage I, however, if 7 or more patients have a response the study will continue to stage II, in which an additional 27 patients (for a total of 38) will be recruited. At the end of stage II, if 26 or less patients have a response, then H0 will be accepted and the treatment regimen deemed not worthy of further study, however, if 27 or more patients have a response, the treatment regimen will be recommended for further study in phase III.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 17, 2020
• Study Start: September 10, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 2, 2020

Record last verified: 2020-06

Locations

CA (1)