Radiation Therapy for Carcinoma, Squamous Cell

Phase-Based Estimates
1
Effectiveness
2
Safety
University of Michigan Rogel Cancer Center, Ann Arbor, MI
Carcinoma, Squamous Cell+1 More
Radiation Therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Squamous Cell

Study Summary

This study is evaluating whether the addition of nivolumab can improve 2 year progression free survival (PFS) as compared to standard of care of fractionated radiation therapy (RT) and carboplatin/paclitaxel in subjects with

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Eligible Conditions

  • Carcinoma, Squamous Cell
  • Oropharynx Squamous Cell Carcinoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Radiation Therapy will improve 1 primary outcome and 5 secondary outcomes in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of Up to 2 years after completion of study treatment.

Week 12
Correlation of mid-treatment FDG-PET scans with post-treatment PET-CT.
Year 2
Incidence of late toxicity
Overall survival (OS)
Progression-free survival (PFS)
Proportion of patients who progressed in any location
Month 6
Incidence of acute toxicity

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Nivolumab, Carboplatin/Paclitaxel, RadiotherapyTherapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after completion of study treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks after completion of study treatment for reporting.

Closest Location

University of Michigan Rogel Cancer Center - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Due to the potential for serious adverse reactions in breastfed infants from carboplatin/paclitaxel and nivolumab, women are advised not to breast-feed during treatment with carboplatin/paclitaxel or nivolumab
Histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization
Clinical stage: stage III AJCC 8th edition staging (cT4 or cN3) OR "matted lymph nodes" (defined as 3 LNs abutting one another with loss of intervening fat plane that is replaced with evidence of extracapsular spread)
History/physical examination, including documentation of weight within 2 weeks prior to registration;
FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration; Zubrod Performance Status 0-1 within 2 weeks prior to registration;
Age ≥ 18;
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3; Platelets ≥ 75,000 cells/mm3; Hemoglobin ≥ 9.0 g/dL AST/ALT <3 x ULN
Total Bilirubin <1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level < 3 x ULN)
Serum creatinine within normal institutional limits or a creatinine clearance ≥ 45 mL/min within 2 weeks prior to registration;
Women of childbearing potential must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and for five months after the last treatment. A woman of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone (FSH) level > 40 mIU/mL to confirm menopause. Men receiving nivolumab who are sexually active with WOCBP must agree to use effective contraception throughout their participation in the treatment phase of the study and for seven months after the last treatment.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can carcinoma, squamous cell be cured?

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Although the cause of squamous cell carcinoma is known, the mechanism for its genesis remains uncertain. However, even with early diagnosis by medical imaging, medical treatment is not curative, and, therefore, the disease must be monitored more frequently and indefinitely.

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How many people get carcinoma, squamous cell a year in the United States?

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around 90,000 cases of carcinoma, squamous cell are diagnosed in the United States each year. The American Cancer Society states that the disease is one of the most common cancers in the United States and that between 60,000 to 80,000 men die from it yearly in the United States.

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What causes carcinoma, squamous cell?

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Habit of smoking certainly plays a role in the development of Squamous cell carcinoma. However, the overall role of other environmental and genetic factors are still undefined.\n

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What are common treatments for carcinoma, squamous cell?

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The treatment options can be grouped in a number of ways. The treatment of carcinoma, squamous cell can be grouped into two kinds: conservative and radical. The conservative treatment includes radiotherapy, surgery, and palliative treatments. The radical treatment includes surgery, radiotherapy or chemotherapy in some cases. The adjuvant radiotherapy for early stage carcinoma, squamous cell will also be discussed.

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What is carcinoma, squamous cell?

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Squamous epithelial cells are cells at the top of the respiratory mucosa and produce the liquid, secretory mucus that forms a very important part of airway defense. Squamous cell carcinoma is commonly a slow-growing, locally advanced cancer characterized by signs and symptoms from distant spread before diagnosis. Squamous cell carcinoma of the head and neck frequently metastasizes to these tissues. SCC is the most aggressive form of head and neck cancer. Most squamous cell carcinomas occur in Caucasians over 20 years of age. SCC is more likely to form in younger age groups than other types of lung cancers. It is more common in males.

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What are the signs of carcinoma, squamous cell?

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The main cause of cancer in our population is smoking, so there is an association between exposure to tobacco and carcinoma, especially for nonsmokers. There is an increase in the number of cancers associated with increasing age and the number of sexual partners in both groups. There was no significant difference between male and female cancer rates; however, the incidence of breast cancer was marginally higher in females.

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Does carcinoma, squamous cell run in families?

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Families with multiple affected members are more likely to have both an affected parent and a clinically affected sibling. Carcinoma, squamous cell run in families.

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Has radiation therapy proven to be more effective than a placebo?

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Radiation Therapy has proven to be significantly more effective than a placebo in patients with early stage squamous cell carcinoma of the glottic larynx and oropharynx. These patients should be offered radiation therapy in treatment plans.

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How serious can carcinoma, squamous cell be?

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Carcinoma, squamous cell is more hazardous to life, and when patients have to go through treatments, the pain and suffering are tremendous. However, the prognosis is not the worst of them all--in fact, it is the opposite. It is true that if diagnosed earlier, the patient can have a more positive prognosis. However, many factors are involved in cancer, and because there are no exact statistics for the number of patients with esophageal cancer that die each year, you should be aware that although the percentage may decrease, the actual magnitude of the problem increases.

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What is the survival rate for carcinoma, squamous cell?

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A patient with carcinoma and squamous cell of the head and neck has an overall average survival of 14-16months and a 5-year survival of 16%. A patient with squamous cell carcinoma of the lung has an overall average survival of 18-19months with a 5-year survival of 19%. There is a significant effect of cigarette smoking, T-staging, and squamous cell of the lung with survival.

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What is the latest research for carcinoma, squamous cell?

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According to the new guideline from The NCCN Collaborative Consensus Statement for the Clinical Practice of Neuro-Oncology (NCOMS-2018), [metastatic carcinoma was treated with surgery or targeted therapies] in Japan.[https://www.cnccns-2018.com/content/home] The [metastatic carcinoma was treated with surgery or targeted therapies] in Japan was highly effective for [postoperative] survival and [progression-free survival] when compared to [treatment with targeted therapies] for metastatic carcinoma.

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Does radiation therapy improve quality of life for those with carcinoma, squamous cell?

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Radiation in combination with chemotherapy may improve overall survival and progression-free survival of patients with carcinoma, squamous cell. Patients may benefit from these treatments primarily in terms of symptom reduction.

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