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Alkylating agents

Reduced-Intensity Chemoradiotherapy for Oropharyngeal Cancer

Phase 2

Waitlist Available

Led By Colette Shen, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx

Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 weeks prior to crt, 6-8 weeks after crt, 6 months after crt (mbs); within 2 weeks prior to crt, 10-16 weeks after crt, follow-up visits every 2 months after crt for 2 years, then every 6 months for 3 years, then yearly (eat-10), up to 10 years.

Awards & highlights

Study Summary

This trial is testing a lower-intensity radiation and chemotherapy regimen to treat HPV-associated head and neck cancers. The goal is to see if it is as effective as the current standard of care while causing fewer side effects.

Who is the study for?

Adults with low-risk HPV-related oropharyngeal squamous cell carcinoma, who are generally healthy and have a light smoking history. They must have good organ function, limited alcohol consumption, and be able to follow the study plan. Pregnant women and those with severe health issues like heart disease or uncontrolled infections cannot participate.Check my eligibility

What is being tested?

The trial is testing if lower-intensity radiation for one less week combined with reduced chemotherapy doses can effectively treat HPV-related head and neck cancers compared to the standard longer treatment. It aims to see if this approach maintains high cure rates while reducing side effects.See study design

What are the potential side effects?

Potential side effects include reactions related to lower doses of chemotherapy such as nausea, fatigue, kidney issues, blood count changes; and from radiation therapy like skin irritation in the treated area, dry mouth or difficulty swallowing.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is in the oropharynx and hasn't spread far.

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My cancer is squamous cell and tests positive for HPV or p16.

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I am fully active or can carry out light work.

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My recent blood tests show enough platelets and hemoglobin.

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My kidney and liver tests are within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 weeks prior to crt, weekly during crt, 10-16 weeks after crt, follow-up visits every 2 months after crt for 2 years, then every 6 months for 3 years, then yearly, up to 10 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 weeks prior to crt, weekly during crt, 10-16 weeks after crt, follow-up visits every 2 months after crt for 2 years, then every 6 months for 3 years, then yearly, up to 10 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 weeks prior to crt, weekly during crt, 10-16 weeks after crt, follow-up visits every 2 months after crt for 2 years, then every 6 months for 3 years, then yearly, up to 10 years. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

2 Year Progression Free Survival After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Secondary outcome measures

Human papillomavirus

2 Year Local Control (LC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

2 Year Local-regional Control (LRC) Rate After De-intensified Chemoradiotherapy (CRT) in Human Papilloma Virus (HPV)-Positive and/or p16 Positive Low-risk Oropharyngeal Squamous Cell Carcinoma (OPSCC)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: De-escalated Radiation and ChemotherapyExperimental Treatment3 Interventions

Patients will receive Intensity Modulated Radiotherapy Treatments (IMRT), 60 Gy at 2 Gy/fx. The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 total doses. Chemotherapy will not be given to patients with T0-2 N0-1 disease, ≤ 10 pack years smoking history. Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity Modulated Radiotherapy (IMRT)

2011

Completed Phase 2

~110

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,217 Total Patients Enrolled

Colette Shen, MDPrincipal InvestigatorUniversity of North Carolina at Chapel Hill, Department of Radiation Oncology

1 Previous Clinical Trials

98 Total Patients Enrolled

Bhishamjit Chera, MDPrincipal InvestigatorUniversity of North Carolina at Chapel Hill, Department of Radiation Oncology

4 Previous Clinical Trials

128 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02281955 — Phase 2

Oropharyngeal Cancer Research Study Groups: De-escalated Radiation and Chemotherapy

Oropharyngeal Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02281955 — Phase 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02281955 — Phase 2

Frequently Asked Questions

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

Has the FDA endorsed Assessment for surgical assessment?

"Based on our assessment, the safety rating for Assessment for surgical evaluation is a 2 as it is currently undergoing Phase 2 trials. While there are some studies vouching for its security, no research has yet demonstrated its efficacy."

Answered by AI

Are there any slots available for participation in this study?

"At present, this clinical trial is not recruiting new patients. It was initially posted on August 1st 2014 and last modified December 15th 2021; however, there are still 5823 other trials in search of participants."

Answered by AI

What medical issues can be helped by Assessment for surgical evaluation?

"Advanced ovarian cancer is often treated with Assessment for surgical evaluation, which can also be beneficial in cases of advanced testicular cancer resistant to typical treatments and advance directives."

Answered by AI

What have been the previous outcomes of investigations into Assessment for surgical evaluation?

"Presently, 688 clinical trials are exploring Assessment for surgical evaluation. 274 of these investigations have reached Phase 3 and the majority of them occur in Shanghai. However, there are 43211 various locations worldwide conducting research on this intervention."

Answered by AI

In what regions of the United States have facilities started administering this medical research?

"Currently, this clinical study is operational at 5 different sites: High Point, Raleigh and Gainesville among them. To reduce commute time, it's recommend that participants select the closest medical facility to their home."

Answered by AI

What is the current cap on participants for this trial?

"This research effort has since concluded its recruitment phase. It was initially posted on August 1st, 2014 and the listing's most recent revision occured December 15th 2021. For those seeking alternative studies, 5135 trials are currently enrolling individuals with head neoplasms while 688 have opened enrollment for Assessment of Surgical Evaluation."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase II Trial of De-intensified Chemoradiotherapy for Human Papillomavirus–associated Oropharyngeal Squamous Cell Carcinoma

Chera, Bhishamjit S., Robert J. Amdur, Rebecca Green, Colette Shen, Gaorav Gupta, Xianming Tan, Mary Knowles, et al.. 2019. “Phase II Trial of De-intensified Chemoradiotherapy for Human Papillomavirus–associated Oropharyngeal Squamous Cell Carcinoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.01007.

Journal of Clinical OncologyJournal

Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in Hpv-associated Oropharyngeal Cancer

Chera, Bhishamjit S., Sunil Kumar, Colette Shen, Robert Amdur, Roi Dagan, Rebecca Green, Emily Goldman, et al.. 2020. “Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in Hpv-associated Oropharyngeal Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.02444.

clinicaltrials.govStudy

De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study

2014. "De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02281955.

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