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Radiation

Radiation, Cisplatin, and Surgery for Throat Cancer (MINT-2 Trial)

Saint Louis, MO

Phase 2

Waitlist Available

Led By Douglas Adkins, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

ECOG PS 0-2

At least 18 years of age

Must not have

Clinical T1N0M0 or T2N0M0 disease

Prior radiation therapy for HNSCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 5 years and 10 weeks)

Awards & highlights

No Placebo-Only Group

Summary

"This trial is studying different treatment options for patients with oropharynx squamous cell carcinoma (OPSCC) caused by the human papillomavirus (HPV). The goal is to reduce

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Who is the study for?

This trial is for individuals with a type of throat cancer called HPV-related oropharynx squamous cell carcinoma. Participants must have undergone surgery to remove the tumor and neck nodes. They are then assigned to different treatment groups based on their pathology reports, except those with the highest or lowest risk who will be advised on standard care.Check my eligibility

What is being tested?

The study tests reduced-intensity treatments after surgery in patients with HPV-related throat cancer to see if they can lower side effects while keeping cancer from coming back. Patients receive varying doses of radiation and some get chemotherapy (Cisplatin), depending on their risk level determined by pathology results.See study design

What are the potential side effects?

Potential side effects include typical reactions to radiation therapy such as skin irritation, fatigue, dry mouth, difficulty swallowing, and nausea. Cisplatin may cause kidney problems, hearing loss, nerve damage, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

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My kidney function, white blood cell, and platelet counts are within the required ranges.

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My cancer is HPV-related, in the early stages, but not the earliest.

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I am scheduled for surgery to remove my tumor through my mouth.

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I am scheduled for a specific type of neck surgery.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is in an early stage and has not spread to lymph nodes or other parts of my body.

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I have had radiation therapy for head and neck cancer.

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I am scheduled for surgery to rebuild the area where my cancer was removed using tissue from another part of my body.

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My liver disease is severe, classified as Child-Pugh B or C.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 5 years and 10 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 5 years and 10 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 5 years and 10 weeks) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Mean change in serum creatinine during radiation therapy

Overall survival (OS)

Percent weight loss

+1 more

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 2C: Radiation therapy + CisplatinExperimental Treatment3 Interventions

* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.

Group II: Arm 2B: Radiation therapyExperimental Treatment2 Interventions

* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3780 cGY in 21 fractions of 180 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3360 cGy in 21 fractions of 160 cGy each.

Group III: Arm 2A: Radiation therapyExperimental Treatment2 Interventions

* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.

Group IV: Arm 1: Radiation therapy + CisplatinExperimental Treatment3 Interventions

* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3040

Surgery

2000

Completed Phase 3

~2490