Cisplatin for Carcinoma, Squamous Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Squamous Cell+8 More
Cisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing a less intense radiation therapy with 2 cycles of standard chemotherapy to the current standard chemoradiation for people with HPV positive and hypoxia negative T1-2, N1-2c oropharyngeal squamous cell carcinoma.

Eligible Conditions
  • Carcinoma, Squamous Cell
  • Squamous cell carcinoma
  • human papillomavirus

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 years (+/- 3 months)

Year 2
Effectiveness of study treatment for participants receiving de-escalated radiation therapy radiation therapy, comparable to participants treated with the current standard of care chemoradiation by standard CT (or MRI) or tumor site and PET scan

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm B: HPV associated oropharyngeal carcinoma
1 of 2
Arm A: HPV associated oropharyngeal carcinoma
1 of 2

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 2

Arm B: HPV associated oropharyngeal carcinomaExperimental Group · 6 Interventions: Cisplatin, Carboplatin, Proton Therapy, 30 Gy over 3 weeks, 5Fluorouracil, F-FMISO PET/CT Scan · Intervention Types: Drug, Drug, Radiation, Radiation, Drug, DiagnosticTest
Arm A: HPV associated oropharyngeal carcinomaExperimental Group · 5 Interventions: Cisplatin, Carboplatin, 30 Gy over 3 weeks, 5Fluorouracil, F-FMISO PET/CT Scan · Intervention Types: Drug, Drug, Radiation, Drug, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Carboplatin
FDA approved
Proton Therapy
2009
Completed Phase 2
~280
5Fluorouracil
2020
Completed Phase 3
~690

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years (+/- 3 months)

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,821 Previous Clinical Trials
584,019 Total Patients Enrolled
20 Trials studying Carcinoma, Squamous Cell
1,069 Patients Enrolled for Carcinoma, Squamous Cell
Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
1,133 Total Patients Enrolled
1 Trials studying Carcinoma, Squamous Cell
17 Patients Enrolled for Carcinoma, Squamous Cell

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Individuals in Cohort B have been diagnosed with HPV-associated squamous cell carcinoma of the oropharynx
Subjects must have a disease that can be seen on an X-ray or by a doctor.
If you have squamous cell carcinoma of the neck of unknown primary, you may be able to have surgery to remove a lymph node for examination (or a core biopsy)
indicates good performance A person who has an ECOG performance status of 0-2 or a Karnopksy performance status of greater than or equal to 50 is considered to have good performance.
Stage 1 cancer with no signs of it spreading to other parts of the body.
- Cohort B: Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from a fine needle aspiration (FNA) or core biopsy specimen with at least 1 positive HPV result on polymerase chain reaction (PCR) assay.
to have PET/CT Patients who have squamous cell carcinoma of the neck of unknown primary are allowed to have PET/CT if they have an excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI.
CT or MRI scans of the neck may be done with or without contrast

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.