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Adjuvant Therapy for HPV-Positive Oropharyngeal Cancer (PATHOS Trial)

Q: What are the risks of postoperative radiation therapy?

There is evidence from Phase 3 clinical trials that postoperative radiotherapy is safe and effective, so it received a score of 3.

Q: Why is postoperative radiotherapy commonly prescribed?

Postoperative radiotherapy is a common treatment for advanced <a href="https://www.withpower.com/clinical-trials/ovarian-cancer">ovarian cancer</a>. It may also be used to treat other forms of cancer like <a href="https://www.withpower.com/clinical-trials/testicular-cancer">testicular cancer</a> that has not responded to initial treatments.

Q: Is there precedent for this course of post-operative treatment?

714 clinical trials for postoperative radiotherapy are currently active, with 284 in Phase 3. Most trials for postoperative radiotherapy are located in Shanghai, but there are 43119 locations running trials for this intervention.

Phase 3

Recruiting

Led By Terrence Jones, MBBS,MD

Research Sponsored by Lisette Nixon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed or suspected squamous cell carcinoma of the oropharynx

UICC/AJCC TNM 7th edition stage T1-T3, N0-N2b (or UICC TNM 8th edition stage T1-T3, N0-N1) disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly during rt and at end of treatment; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks), 6 months (+/- 4 weeks), 12 months (+/- 4 weeks), and 24 months (+/- 8 weeks) post treatment.

Awards & highlights

PATHOS Trial Summary

This trial is testing whether reducing the intensity of treatment for HPV-positive OPSCC patients who have had surgery to remove the tumor improves swallowing function without reducing overall survival rates.

Who is the study for?

The PATHOS trial is for adults over 18 with HPV-positive oropharyngeal cancer, who are fit for surgery and postoperative radiotherapy. It's not for those with HPV-negative tumors, distant metastatic disease, a recent history of other cancers (except certain skin/cervix cancers), pregnant/breastfeeding women not using contraception, or anyone with pre-existing conditions affecting swallowing.Check my eligibility

What is being tested?

This study tests if reducing the intensity of adjuvant treatments like Cisplatin and radiotherapy after transoral resection improves swallowing function in patients with HPV-positive oropharyngeal cancer without compromising overall survival.See study design

What are the potential side effects?

Potential side effects from Cisplatin and postoperative radiotherapy may include nausea, vomiting, kidney damage, hearing loss, mouth sores, difficulty swallowing (dysphagia), dry mouth (xerostomia), and fatigue.

PATHOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My throat cancer is suspected or confirmed to be squamous cell.

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My cancer is at an early to mid-stage, not spread widely.

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My treatment plan includes surgery through the mouth and neck surgery, as decided by my healthcare team.

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I am 18 years old or older.

PATHOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 4 weeks (+/- 2 weeks) post-surgery, prior to start of any adjuvant treatment; 4 weeks (+/- 2 weeks) post treatment; 6 months (+/- 4 weeks) post treatment; 12 months (+/- 4 weeks) post treatment; 24 months (+/- 8 weeks) post treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MDADI/Overall survival co-primary endpoint

Secondary outcome measures

Acute and late toxicity using CTACE version 4.03

Disease Free Survival

Distant Metastases

+3 more

PATHOS Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: C2: Postoperative radiotherapy 60 Gray without chemotherapyExperimental Treatment1 Intervention

Arm C2: Postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks without chemotherapy (Test Arm C2). Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease

Group II: B2: Postoperative radiotherapy 50 GrayExperimental Treatment1 Intervention

Arm B2: Postoperative radiotherapy (PORT) at a dose 50 Gray in 25 fractions over 5 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.

Group III: A: No adjuvant treatmentActive Control1 Intervention

Group A Patients with tumours which exhibit no adverse histological features. Patients in this group will not receive any adjuvant treatment as per standard of care.

Group IV: B1: Postoperative radiotherapy 60 GrayActive Control1 Intervention

Arm B1: postoperative radiotherapy (PORT) at a dose of 60 Gray (Gy) in 30 fractions over 6 weeks. Group B: Patients with: T3 tumours (or T1-T2 tumours with additional risk factors), TNM 7th edition pN2a (metastasis in single ipsilateral node 31-60 mm diameter) or pN2b (metastasis in multiple ipsilateral nodes <61 mm diameter) disease, tumours with evidence of perineural and/or vascular invasion, and/or a histologically normal tissue margin around the primary tumour of 1-5mm and, in the case of TLM, marginal biopsies free of tumour.

Group V: C1: Postoperative radiotherapy 60 Gray with CisplatinActive Control2 Interventions

Arm C1: postoperative radiotherapy at a dose of 60 Gray in 30 fractions over 6 weeks with concurrent Cisplatin chemotherapy (POCRT). Cisplatin may be given 3 weekly (100mg/m2 week 1 and week 4 of radiotherapy) or weekly (40mg/m2 weekly during radiotherapy), according to local practice. Group C: Patients with tumours of any T or any N stage, which exhibit the following high risk pathological features will be included: A histologically normal tissue margin around the primary tumour of <1mm and, in the case of TLM, marginal biopsies free of tumour and /or extracapsular spread (ECS) of nodal disease

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lisette NixonLead Sponsor

7 Previous Clinical Trials

2,474 Total Patients Enrolled

UNICANCEROTHER

221 Previous Clinical Trials

281,786 Total Patients Enrolled

AdventHealthOTHER

106 Previous Clinical Trials

28,437 Total Patients Enrolled

Media Library

Oropharyngeal Cancer Research Study Groups: A: No adjuvant treatment, B1: Postoperative radiotherapy 60 Gray, B2: Postoperative radiotherapy 50 Gray, C1: Postoperative radiotherapy 60 Gray with Cisplatin, C2: Postoperative radiotherapy 60 Gray without chemotherapy

Oropharyngeal Cancer Clinical Trial 2023: Postoperative radiotherapy Highlights & Side Effects. Trial Name: NCT02215265 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks of postoperative radiation therapy?

"There is evidence from Phase 3 clinical trials that postoperative radiotherapy is safe and effective, so it received a score of 3."

Answered by AI

Why is postoperative radiotherapy commonly prescribed?

"Postoperative radiotherapy is a common treatment for advanced ovarian cancer. It may also be used to treat other forms of cancer like testicular cancer that has not responded to initial treatments."

Answered by AI

Is there precedent for this course of post-operative treatment?

"714 clinical trials for postoperative radiotherapy are currently active, with 284 in Phase 3. Most trials for postoperative radiotherapy are located in Shanghai, but there are 43119 locations running trials for this intervention."

Answered by AI

Recent research and studies

BMC CancerJournal

PATHOS: A Phase II/III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV) Positive Oropharyngeal Cancer

Owadally, Waheeda, Chris Hurt, Hayley Timmins, Emma Parsons, Sarah Townsend, Joanne Patterson, Katherine Hutcheson, et al.. 2015. “PATHOS: A Phase II/III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV) Positive Oropharyngeal Cancer”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-015-1598-x.

clinicaltrials.govStudy

Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)

Lisette Nixon 2015. "Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02215265.

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