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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival Rate at 2 Years

Hemorrhage

Secondary study objectives

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 study objectives

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%

Cough

10%

Hypomagnesemia

10%

Urinary tract pain

10%

Urinary urgency

10%

Urinary tract infection

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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