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Anti-metabolites
Reduced Radiation + Chemotherapy for Throat Cancer
Phase 2
Recruiting
Led By Nancy Lee, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether lower doses of radiation, in combination with chemotherapy, may help reduce side effects in people with HPV-positive throat cancer.
Who is the study for?
This trial is for adults with HPV-positive throat cancer who have measurable disease, confirmed diagnosis, and adequate organ function. They must not have had prior head and neck radiation or chemotherapy for the current cancer, no other simultaneous primary cancers, and no severe active co-morbidities.
What is being tested?
The study tests if lower doses of radiation combined with standard chemotherapy (cisplatin, carboplatin, 5-fluorouracil) can reduce side effects in treating HPV-positive throat cancer. It includes imaging like PET/CT scans to assess treatment effectiveness.
What are the potential side effects?
Potential side effects include reactions to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk; kidney or liver function changes; and typical radiation therapy side effects like skin irritation and difficulty swallowing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with any locoregional recurrences
Side effects data
From 2022 Phase 2 trial • 26 Patients • NCT0304380781%
fatigue
38%
hot flashes
38%
neuropathy
19%
alopecia;
19%
dysgeusia
15%
hiccups
15%
nausea
15%
skin alterations
12%
diarrhea
12%
gastritis
12%
edema (lower extremity)
12%
rash
12%
constipation
8%
anxiety
8%
xerosis
4%
elevated ALT
4%
hematochezia
4%
cough
4%
elevated AST
4%
xerostomia
4%
general body aches
4%
pruritis
4%
nail discoloration
4%
fever
4%
anemia
4%
epistaxis
4%
infusion related reaction
4%
neutropenia
4%
neutropenic fever
4%
gastrointestinal reflux
4%
pain (bilateral legs)
4%
mucositis
4%
pain (joint);
4%
anorexia
4%
nail ridging
4%
weight gain
4%
hematuria
4%
urinary tract obstruction
4%
oral candidiasis
4%
insomnia
4%
depression
4%
dyspnea
4%
arthritis
4%
pain (pelvis)
4%
memory impairment
4%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemohormonal and Definitive Therapy After Prostatectomy
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: Cohort DExperimental Treatment5 Interventions
Participants diagnosed with hypoxia negative human papilloma virus (HPV) associated oropharyngeal carcinoma (OPC). Cohort D will just have T1- T2N0 participants. Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel). Will follow the guidelines for Cohort A and Cohort B for chemotherapy options.
Group II: Cohort CExperimental Treatment5 Interventions
Participants diagnosed with hypoxia negative human papilloma virus (HPV) associated oropharyngeal carcinoma (OPC). For participants in Cohort C where induction chemotherapy is used, additional pre-treatment 18F-FMISO PET and post induction pre radiation FMISO PET Scans will be obtained. These patients will start with induction chemotherapy of carboplatin, paclitaxel with or without cetuximab for 6 weeks and follow the same precision chemoradiation algorithm as Cohort A. A window of +/- 2 days is acceptable during the induction phase Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel). For patients who cannot tolerate paclitaxel, Abraxane and the dose will be at 100mg/m\^2.
Group III: Cohort BExperimental Treatment5 Interventions
Participants diagnosed with hypoxia negative human papilloma virus (HPV) associated oropharyngeal carcinoma (OPC). Participants in Cohort B will receive 1 cycle of carboplatin and Paclitaxol the same week of the start of radiation. Paclitaxel can be substituted with Abraxane (Albumin-bound Paclitaxel). Paclitaxel can be substituted with Abraxane and the dose will be 50mg/m\^2. For Cohort B, patients over 70yrs will be able to enroll regardless of Cisplatin or carboplatin/5-fluorouracil (FU) eligibility.
Group IV: Cohort AExperimental Treatment5 Interventions
Participants diagnosed with hypoxia negative human papilloma virus (HPV) associated oropharyngeal carcinoma (OPC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 2
~780
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120
5-fluorouracil
2005
Completed Phase 4
~8440
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,973 Previous Clinical Trials
597,617 Total Patients Enrolled
Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
16 Previous Clinical Trials
2,384 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received chemotherapy for my current cancer.My throat cancer is caused by HPV.I cannot tolerate certain chemotherapy drugs and will receive specific alternatives.I have liver problems causing jaundice or blood clotting issues.I am 18 or older. If over 70, I understand I can only join Cohort B.I have had radiation therapy for head or neck cancer.My cancer can be seen or measured on scans.My throat cancer has not spread to distant parts of my body, confirmed by a PET/CT scan.I have had a biopsy to remove or examine a piece of my tumor.My liver is working well, as tested within the last 30 days.My kidney function is normal as tested within the last 30 days.I have more than one primary cancer, not in the oropharynx.I've been cancer-free for 3 years, except for non-dangerous skin cancers.I can take care of myself but may not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort A
- Group 3: Cohort C
- Group 4: Cohort D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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