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Platinum-based Chemotherapy

Reduced Dose Radiotherapy for Oropharyngeal Cancer

Phase 3

Waitlist Available

Led By Marshall Posner, M.D.

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Participants must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, unknown primary, or nasopharynx that is HPV positive as determined by PCR and p16 positive as determined by IHC. Tissue from the primary site must be available for biomarker studies. PCR and IHC must be performed in the central laboratory (Zhang, MSSM)

Stage 3 or 4 disease without evidence of distant metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 years

Awards & highlights

Study Summary

This trial is comparing a reduced amount of radiation to the standard amount given in cancer treatment to see if it is just as effective. They are testing to see if the reduced amount will have the same effect on the patient's cancer and if it will help them live just as long.

Who is the study for?

Adults over 18 with HPV-positive oropharyngeal cancer, who haven't had previous cancer treatments and are in good physical condition. They must not be pregnant, have no other current cancers (with some exceptions), and can't have a history of significant alcohol or drug abuse within the last six months.Check my eligibility

What is being tested?

The trial is testing if a lower dose of radiation combined with Carboplatin is as effective as the standard higher dose for treating HPV-related throat cancer. Patients will be compared based on local-regional control and progression-free survival after three years.See study design

What are the potential side effects?

Potential side effects include those common to radiation therapy such as skin irritation, fatigue, dry mouth, difficulty swallowing, and changes in taste. Carboplatin may cause nausea, low blood counts leading to infection risk, kidney issues, hearing problems or nerve damage.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is HPV positive and confirmed by specific tests.

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My condition is advanced but hasn't spread far.

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I have at least one tumor that can be measured.

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I am fully active or can carry out light work.

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I am older than 18 years.

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I have not had surgery, radiation, or chemotherapy for my cancer, except for a biopsy or tonsillectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 and 5 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

Number of Participants With Progression Free Survival (PFS)

Secondary outcome measures

Biomarkers Predictive of Failure

Change in European Organization for Research and Treatment of Cancer Questionnaire for Head and Neck (EORTC HN)

Change in MD Anderson Dysphagia Inventory (MDADI) From Baseline

+6 more

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100

60%

ALOPECIA

51%

NAUSEA

45%

ARTHRALGIA

44%

ANAEMIA

38%

FATIGUE

35%

HYPERTENSION

35%

CONSTIPATION

35%

DIARRHOEA

30%

NEUTROPENIA

28%

PERIPHERAL SENSORY NEUROPATHY

28%

ABDOMINAL PAIN

28%

NEUTROPHIL COUNT DECREASED

24%

NEUROPATHY PERIPHERAL

24%

RASH

23%

HEADACHE

23%

VOMITING

22%

WHITE BLOOD CELL COUNT DECREASED

22%

MYALGIA

21%

PROTEINURIA

21%

EPISTAXIS

21%

PLATELET COUNT DECREASED

21%

THROMBOCYTOPENIA

19%

DECREASED APPETITE

18%

HYPOTHYROIDISM

17%

URINARY TRACT INFECTION

16%

COUGH

16%

PYREXIA

15%

STOMATITIS

14%

HYPOMAGNESAEMIA

14%

ASPARTATE AMINOTRANSFERASE INCREASED

14%

BACK PAIN

14%

INSOMNIA

14%

ALANINE AMINOTRANSFERASE INCREASED

14%

DYSPNOEA

14%

PRURITUS

13%

WEIGHT DECREASED

13%

PAIN IN EXTREMITY

12%

DIZZINESS

12%

INFUSION RELATED REACTION

12%

ASTHENIA

11%

LEUKOPENIA

11%

HYPOKALAEMIA

10%

UPPER RESPIRATORY TRACT INFECTION

DYSGEUSIA

ABDOMINAL PAIN UPPER

FEBRILE NEUTROPENIA

HYPOAESTHESIA

WEIGHT INCREASED

HYPERTHYROIDISM

BONE PAIN

LYMPHOCYTE COUNT DECREASED

DYSPHONIA

MUCOSAL INFLAMMATION

MUSCULAR WEAKNESS

HYPONATRAEMIA

PARAESTHESIA

OROPHARYNGEAL PAIN

DYSPEPSIA

RASH MACULO-PAPULAR

HYPERGLYCAEMIA

BLOOD ALKALINE PHOSPHATASE INCREASED

OEDEMA PERIPHERAL

NASOPHARYNGITIS

ABDOMINAL DISTENSION

ANXIETY

PAIN

DEPRESSION

DRY MOUTH

MALAISE

NASAL CONGESTION

VISION BLURRED

DRY SKIN

URTICARIA

HOT FLUSH

NECK PAIN

GASTROOESOPHAGEAL REFLUX DISEASE

ILEUS

PNEUMONIA

PULMONARY EMBOLISM

COLITIS

SMALL INTESTINAL OBSTRUCTION

PERITONITIS

LIVER INJURY

INTESTINAL OBSTRUCTION

UROSEPSIS

DEHYDRATION

TRANSIENT ISCHAEMIC ATTACK

PNEUMONITIS

ABDOMINAL ABSCESS

INFECTED LYMPHOCELE

PYELONEPHRITIS

100%

80%

60%

40%

20%

Study treatment Arm

Placebo With Paclitaxel, Carboplatin and Bevacizumab

Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reduced Dose RadiationExperimental Treatment2 Interventions

Patients randomized to receive a reduced (5600 cGy) dose radiotherapy with weekly Carboplatin

Group II: Standard Dose RadiationActive Control2 Interventions

Patients randomized to receive a standard (7000 cGy) dose radiotherapy with carboplatin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

858 Previous Clinical Trials

524,263 Total Patients Enrolled

The Biodesign InstituteUNKNOWN

Arizona State UniversityOTHER

283 Previous Clinical Trials

109,491 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01706939 — Phase 3

Squamous Cell Carcinoma Research Study Groups: Reduced Dose Radiation, Standard Dose Radiation

Squamous Cell Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01706939 — Phase 3

Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01706939 — 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 most common conditions that Carboplatin is used to remedy?

"Carboplatin is primarily used to treat lymphoma and non-hodgkin, but it can also be effective for advanced sarcoma, initial treatment, and hodgkin disease."

Answered by AI

Are we still looking for more volunteers for this research project?

"This cancer research trial is not currently recruiting patients. The listing was originally posted on September 1st, 2012 and was updated on August 11th, 2022. For other trials, there are 146 cancer of the oropharynx studies and 726 Carboplatin trials that are actively recruiting patients."

Answered by AI