← Back to Search

Transoral Surgery + Radiation Therapy + Chemotherapy for Oropharyngeal Cancer

Phase 2

Waitlist Available

Led By Robert Ferris

Research Sponsored by Eastern Cooperative Oncology Group

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed 4-6 weeks after surgery

Awards & highlights

Study Summary

This trial is testing different doses of radiation therapy given with chemotherapy after transoral surgery for HPV positive stage III-IVA oropharyngeal cancer.

Who is the study for?

This trial is for adults with HPV-positive stage III-IVA oropharyngeal cancer. Participants must have resectable disease, good performance status (ECOG 0 or 1), and proper organ function. They should not have had prior radiation above the clavicles, be pregnant, or have uncontrolled conditions like diabetes. Contraception is advised for those who can bear children.Check my eligibility

What is being tested?

The study tests how well transoral surgery followed by low-dose or standard-dose radiation therapy works when treating HPV-related throat cancer. It also examines if adding chemotherapy with drugs like cisplatin or carboplatin improves outcomes after surgery.See study design

What are the potential side effects?

Possible side effects include soreness from surgery, skin irritation from radiation, and typical chemotherapy effects such as nausea, fatigue, hair loss, increased infection risk due to lowered blood cell counts, and potential harm to kidneys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed 4-6 weeks after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed 4-6 weeks after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 4-6 weeks after surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free Survival Rate at 2 Years

Hemorrhage

Secondary outcome measures

Distribution of Histologic Risk Status

Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score

Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)

+1 more

Other outcome measures

Association Between Radiation Resistance Markers and Progression-free Survival

Association Between TP53 Mutation and Progression-free Survival

Usefulness of Biomarkers in Predicting Progression-free Survival

Side effects data

From 2022 Phase 3 trial • 289 Patients • NCT01672892

77%

Diarrhea

73%

Fatigue

39%

Nausea

37%

Abdominal pain

30%

Urinary frequency

21%

Anemia

21%

Constipation

21%

Anorexia

18%

Urinary incontinence

18%

Pelvic pain

17%

White blood cell decreased

16%

Edema limbs

16%

Pain

13%

Dyspnea

13%

Vomiting

13%

Headache

12%

Paresthesia

11%

Lymphocyte count decreased

10%

Bloating

10%

Hypomagnesemia

10%

Urinary tract pain

10%

Urinary urgency

10%

Urinary tract infection

10%

Cough

10%

Hot flashes

10%

Insomnia

Platelet count decreased

Rectal pain

Gastrointestinal disorders - Other

Proctitis

Hyperglycemia

Hyponatremia

Anxiety

Renal and urinary disorders - Other

Weight loss

Depression

Cystitis noninfective

Alopecia

Tinnitus

Blurred vision

Neutrophil count decreased

Hypokalemia

Back pain

Generalized muscle weakness

Peripheral sensory neuropathy

Vaginal discharge

Vaginal hemorrhage

Pruritus

Hypertension

Dermatitis radiation

Dyspepsia

Hypoalbuminemia

Rectal hemorrhage

Vaginal stricture

Arthralgia

Skin and subcutaneous tissue disorders - Other

Device related infection

Vaginal pain

100%

80%

60%

40%

20%

Study treatment Arm

Intensity-Modulated Radiation Therapy

Standard Radiation Therapy

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm S (Surgery) then Arm D (High risk, IMRT, chemotherapy)Experimental Treatment4 Interventions

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.

Group II: Arm S (Surgery) then Arm C (Intermediate risk, standard-dose IMRT)Experimental Treatment2 Interventions

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.

Group III: Arm S (Surgery) then Arm B (Intermediate risk, low-dose IMRT)Experimental Treatment2 Interventions

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.

Group IV: Arm S (Surgery) then Arm A (Low risk, observation)Experimental Treatment1 Intervention

Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

intensity-modulated radiation therapy

2008

Completed Phase 3

~1490

cisplatin

1997

Completed Phase 3

~3290

carboplatin

2010

Completed Phase 3

~4790

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor

268 Previous Clinical Trials

150,311 Total Patients Enrolled

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,403 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,634 Total Patients Enrolled

Media Library

Transoral surgery Clinical Trial Eligibility Overview. Trial Name: NCT01898494 — Phase 2

Human Papillomavirus Research Study Groups: Arm S (Surgery) then Arm A (Low risk, observation), Arm S (Surgery) then Arm B (Intermediate risk, low-dose IMRT), Arm S (Surgery) then Arm C (Intermediate risk, standard-dose IMRT), Arm S (Surgery) then Arm D (High risk, IMRT, chemotherapy)

Human Papillomavirus Clinical Trial 2023: Transoral surgery Highlights & Side Effects. Trial Name: NCT01898494 — Phase 2

Transoral surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT01898494 — 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 sanctioned intensity-modulated radiation therapy?

"After careful consideration, our team at Power assigned a risk rating of 2 to intensity-modulated radiation therapy as this falls under Phase 2 clinical trials. This suggests that there is some data available supporting its safety but no evidence yet confirming efficacy."

Answered by AI

How many participants are engaged in this research endeavor?

"Unfortunately, recruitment for this study has closed. It was initially posted on July 9th 2013 and most recently updated on September 29th 2022. If you are searching for similar trials, 2719 clinical studies are currently recruiting participants with human papillomavirus infections while 1135 intensity-modulated radiation therapy trials actively admit patients."

Answered by AI

What conditions are commonly treated with intensity-modulated radiation therapy?

"Intensity-modulated radiation therapy is known to be a successful treatment for malignant melanoma and other diseases such as neoplasm metastasis, advanced directives, and non-Hodgkin's lymphoma."

Answered by AI

What is the geographical scope of this research endeavor?

"UCLA/Jonsson Comprehensive Cancer Center in Los Angeles, Stanford Cancer Institute in Palo Alto, Florida and the University of Miami Miller School of Medicine-Sylvester Cancer Center are just a few of the 59 medical centres participating in this trial."

Answered by AI

What is the overarching goal of this clinical experiment?

"This clinical trial will assess Progression-free Survival Rate over a period of 18 months as its primary outcome. Secondary outcomes to be monitored include Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and neck cancer (FACT-HN), Distribution of Histologic Risk Status, and Swallowing Function After Surgery Assessed Using MD Anderson Dysphagia Inventory (MDADI)."

Answered by AI

Are there any current opportunities for participation in this research endeavor?

"As advertised on clinicaltrials.gov, this medical trial is no longer accepting applications. The study was initially posted in 2013 and last updated in September 2022; however, there are an abundance of similar trials that are still actively searching for participants at the moment."

Answered by AI

What past experiments have focused on intensity-modulated radiation therapy?

"Presently, 1135 separate studies for intensity-modulated radiation therapy are being conducted. Of these trials, 379 reside in the third phase of development. Most of the clinical sites administering this treatment can be found in Shanghai; however there are 64980 total locations around the world running related experiments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer

2014. "Transoral Surgery Followed By Low-Dose or Standard-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With HPV Positive Stage III-IVA Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01898494.

All > Basal Cell Carcinoma > Hpv