What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC), particularly involving Cisplatin combined with radiation therapy, are associated with several side effects. Cisplatin can cause nephrotoxicity, ototoxicity, neurotoxicity, and gastrointestinal issues like nausea and vomiting. When used with radiation therapy, additional side effects include mucositis, dysphagia, and increased infection risk due to immunosuppression. Severe skin reactions and hypomagnesemia are also noted. These side effects can significantly impact the patient's quality of life and may require supportive care.

What prior FDA approvals exist?

Cisplatin, a platinum-based chemotherapy drug, has been FDA-approved for the treatment of Squamous Cell Carcinoma (SCC) due to its mechanism of causing DNA damage and generating reactive oxygen species (ROS). Other related FDA-approved treatments include combination therapies such as cisplatin with fluorouracil (FU) and docetaxel, which have been used in various SCC treatment regimens. Additionally, cetuximab, an EGFR inhibitor, has been approved for use in combination with platinum-based chemotherapy for recurrent or metastatic SCC of the head and neck.

What other types of research exist?

Promising novel alternatives to cisplatin for squamous cell carcinoma patients include immune checkpoint inhibitors such as pembrolizumab and atezolizumab. Pembrolizumab, in combination with chemotherapy, has shown improved overall survival and progression-free survival in patients with advanced squamous non-small cell lung cancer (NSCLC), which is a similar type of cancer. Additionally, small molecule tyrosine kinase inhibitors like afatinib and gefitinib have been tested, although they have not yet demonstrated a significant increase in overall survival. These alternatives offer different mechanisms of action compared to cisplatin, potentially reducing the associated toxicities.

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Alkylating agents

Cisplatin + Radiation for Head and Neck Cancer

Phase 2

Recruiting

Led By Susanne Arnold, MD

Research Sponsored by Susanne Arnold

Eligibility Criteria Checklist

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

Must have

Patients with a history of prior head and neck malignancy must be able to tolerate full dose radiation and chemotherapy

No prior chemotherapy for the current locally advanced SCCHN is allowed

Must not have

HIV-positive patients with uncontrolled HIV

Patients who had recent chemotherapy or radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial involves treating patients with advanced head and neck cancer using a combination of radiation and the chemotherapy drug cisplatin. The goal is to see how effective this treatment is and how it affects patients. Different dosing schedules of cisplatin during radiation are being explored for efficacy and toxicity.

Who is the study for?

Adults with certain types of head and neck cancer (SCCHN) who haven't had chemotherapy for their current advanced cancer can join. They must be able to tolerate full treatment, have no distant metastases, and agree to use effective birth control. Those with significant hearing loss or other recent cancers (except specific cases in remission), uncontrolled illnesses, or pregnant/nursing women cannot participate.

What is being tested?

The trial is testing the effectiveness of standard radiation therapy combined with cisplatin given either weekly or every three weeks on SCCHN. It also examines how the drug's toxicity relates to oxidative stress markers produced during treatment.

What are the potential side effects?

Cisplatin may cause side effects like kidney damage, hearing loss, nausea and vomiting, blood cell count changes increasing infection risk, nerve damage leading to numbness or tingling sensations. Radiation therapy might result in skin irritation at the treated site, fatigue, dry mouth or throat discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I had head or neck cancer before and can handle the full dose of radiation and chemotherapy.

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I have not received chemotherapy for my advanced head or neck cancer.

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I am 18 years old or older.

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My cancer has not spread to distant parts of my body.

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I have been diagnosed with squamous cell carcinoma in my head or neck.

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I can take care of myself and am up and about more than half of my waking hours.

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My organ and bone marrow functions are normal.

Exclusion Criteria

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

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I am HIV-positive with uncontrolled HIV.

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I recently underwent chemotherapy or radiotherapy.

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I have not had certain types of cancer before.

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I do not have any uncontrolled illnesses.

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I have severe hearing loss.

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My cancer has spread from its original location.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse event rate

Secondary study objectives

Local control rates

Survival

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Weekly Cisplatin + XRTExperimental Treatment2 Interventions

Weekly Cisplatin + XRT

Group II: Every 3 Weeks Cisplatin + XRTExperimental Treatment2 Interventions

Every 3 Weeks Cisplatin + XRT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

XRT

1997

N/A

~40

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cisplatin, a common treatment for Squamous Cell Carcinoma (SCC), exerts its effects by causing DNA damage and generating reactive oxygen species (ROS). The DNA damage inhibits cancer cell replication, while ROS further damages cellular components, leading to cell death. This dual mechanism is crucial for effectively targeting and killing SCC cells, thereby improving treatment outcomes for patients.

Alleviation of cytotoxic therapy-induced normal tissue damage.Comparison of Carboplatin With 5-Fluorouracil vs. Cisplatin as Concomitant Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma.Emerging therapeutic options for platinum-sensitive ovarian cancer patients.