Treatment for Paranasal Sinuses

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Paranasal Sinuses+3 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)

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Eligible Conditions

  • Paranasal Sinuses
  • Squamous Cell Carcinoma (SCC)
  • the Nasal Cavity

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 3 secondary outcomes in patients with Paranasal Sinuses. Measurement will happen over the course of through study completion, an average of 1 year.

Year 1
To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC
To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC
To improve the following efficacy endpoints relative to historical results with chemotherapy alone
To increase overall response rate (ORR)

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

0 Treatment Group

This trial requires 35 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Paranasal Sinuses or one of the other 3 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male/female participants who are at least 18 years of age on the day of signing informed consent with newly diagnosed, previously untreated, histologically and/or cytologically confirmed diagnosis of Stage II-IVb PNS SCC will be enrolled in this study.
A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period.
Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Have measurable disease based on RECIST 1.1.
Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Have adequate organ function as defined in the following table (Table 1). Blood must be collected within 14 days prior to the start of study treatment.

Patient Q&A Section

Does carcinoma, squamous cell run in families?

"This family history of hereditary nonmelanoma skin cancers does not appear to result from either autosomal dominant inheritance or incomplete penetrance. However, further studies are needed to confirm these results." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, squamous cell?

"Clinical trials for carcinoma, squamous cell, are worthwhile for several reasons. First, clinical trials are often better than no treatment at all when they compare survival rates to traditional treatments; second, clinical trials provide important information regarding the effectiveness of different types of treatments; third, clinical trials also allow doctors to help patients make decisions regarding treatment options; and fourth, clinical trials can be very useful in educating patients about the nature of their disease and the benefits and risks of various treatments. To find active lung cancer clinical trials in your area, visit the Power website (www.withpower.com) to search by condition, treatment, or location." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, squamous cell?

"The 5-year survival rate for carcinoma, squamous cell was 36.4%. Survival rates were similar between women and men, but outcomes seem to be worse among those 65 years old or older." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"There has been no clinical trial conducted on the treatment of cervical cancer. There was one randomized study for patients with head and neck cancer, which showed that cisplatin plus cetuximab had better outcomes than cisplatin alone (P = 0.001). However, the results were not conclusive because the study was not blinded in its conclusions. The conclusion about the superiority of either regimen cannot be drawn until another study is conducted. For example, this study included only 35 patients in the cisplatin plus cetuximab arm, while there were 103 patients in the cisplatin arm. Therefore, the difference between the two groups could not be statistically significant." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"There are no randomized controlled trials to support the use of adjuvant therapy with radiotherapy alone or chemoradiotherapy + chemotherapy alone in resected oesophageal cancer. Any treatment should be considered as part of the multimodality approach." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, squamous cell?

"Carcinoma has almost all of the signs of squamous cell. The only way to determine if it is carcinoma (rather than squamous cell) is to biopsy. If that is negative for carcinoma, then the lesion must be determined as an invasion of squamous epithelium or microcytic anaplasia. Microcytic anaplasia has the appearance of dyskeratosis and may be confused with squamous cell carcinoma on histologic examination; thus, this benign entity requires careful observation before its differential diagnosis with SCC can be definitively established. Endoscopy and cytopathology are key for the diagnosis of SCC." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The most common side effects of chemotherapy are nausea (60%), vomiting (50%), fatigue (46%), and hair loss (45%). Side effects were most frequent in the first few cycles but diminished after two or more treatment cycles. Only 9% of patients discontinued treatment due to side effects. Patients who developed severe hypersensitivity reactions during the first three cycles had an increased risk of developing neutropenia compared with patients who did not develop hypersensitivity reactions." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma, squamous cell?

"The discovery of new anticancer agents has not been as prolific as previously thought. In fact, only two new anticancer agents have been approved since the 1990s. Many new anticancer agents are either in clinical development or at various stages of preclinical testing. The most commonly used anticancer agents are those that target the mitotic apparatus. These include vinca alkaloids, taxanes, epothilones, hsp90 inhibitors, proteasome inhibitors, PARP inhibitors, topoisomerase II inhibitors and DNA damage repair inhibitors." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, squamous cell spread?

"There is substantial variation in the time interval between the appearance of dysplasia and invasive cancer. The average time interval was 22 months, but this ranged from 4 weeks to more than 13 years. We were unable to attribute this variability to patient characteristics, treatment, or pathology." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, squamous cell?

"In most textbooks, carcinoma, squamous cell is defined as a malignant neoplasm of squamous epithelium (i.e. squamous cell tumors). However, we argue that this definition should be reconsidered. We propose that carcinoma, squamous cell ought to include tumors of non-epithelial origin, e.g., adenocarcinomas of the lung. The term'squamous cell carcinoma', therefore, would refer to a subset of tumors arising from squamous epithelium. Given that adenocarcinomas of the lung are the most common form of lung cancer worldwide, it seems reasonable to suggest that carcinoma, squamous cell could encompass most lung cancers occurring in smokers." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma, squamous cell be?

"Carcinoma, squamous cell may present as a life-threatening disease if left untreated, especially if the lesion involves the airways or nearby structures. For this reason, prompt diagnosis and treatment of cervical cancer is imperative." - Anonymous Online Contributor

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