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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with any locoregional recurrences
Side effects data
From 2008 Phase 3 trial • 243 Patients • NCT0021612560%
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
54%
LEUKOCYTES (TOTAL WBC)
51%
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
48%
DYSPNEA (SHORTNESS OF BREATH)
43%
ESOPHAGITIS
38%
NAUSEA
36%
HEMOGLOBIN
35%
HAIR LOSS/ALOPECIA (SCALP OR BODY)
35%
COUGH
33%
PAIN
32%
ANOREXIA
31%
PAIN - OTHER (SPECIFY, __)
29%
PLATELETS
26%
VOMITING
26%
CONSTIPATION
24%
DIARRHEA
19%
MOOD ALTERATION
18%
NEUROPATHY: SENSORY
18%
INFECTION - OTHER (SPECIFY, __)
18%
WEIGHT LOSS
17%
DIZZINESS
15%
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
15%
PNEUMONITIS/PULMONARY INFILTRATES
15%
HEARTBURN/DYSPEPSIA
13%
INSOMNIA
13%
INFECTION - OTHER
12%
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
12%
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
11%
DEHYDRATION
11%
GASTROINTESTINAL - OTHER (SPECIFY, __)
11%
HYPOTENSION
10%
LYMPHOPENIA
10%
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY
10%
RASH/DESQUAMATION
10%
RASH: DERMATITIS ASSOCIATED WITH RADIATION
8%
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC)
8%
CARDIAC GENERAL - OTHER (SPECIFY, __)
8%
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
7%
ALKALINE PHOSPHATASE
7%
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
7%
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY)
7%
SWEATING (DIAPHORESIS)
7%
SODIUM, SERUM-LOW (HYPONATREMIA)
7%
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
6%
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
6%
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA
6%
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
6%
AUDITORY/EAR - OTHER (SPECIFY, __)
6%
SYNCOPE (FAINTING)
6%
METABOLIC/LABORATORY - OTHER (SPECIFY, __)
5%
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
5%
HICCOUGHS (HICCUPS, SINGULTUS)
5%
CREATININE
5%
PLEURAL EFFUSION (NON-MALIGNANT)
4%
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
4%
HYPERTENSION
4%
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
4%
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
4%
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)
4%
THROMBOSIS/THROMBUS/EMBOLISM
4%
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
4%
RIGORS/CHILLS
4%
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
4%
MUCOSITIS/STOMATITIS (CLINICAL EXAM)
4%
NEUROPATHY: MOTOR
2%
HYPOXIA
2%
COAGULATION - OTHER (SPECIFY, __)
2%
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
2%
HEMORRHAGE/BLEEDING - OTHER
2%
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS
2%
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
2%
PERICARDIAL EFFUSION (NON-MALIGNANT)
2%
BICARBONATE, SERUM-LOW
2%
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
2%
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
2%
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
2%
MEMORY IMPAIRMENT
1%
OCULAR/VISUAL - OTHER (SPECIFY, __)
1%
RENAL/GENITOURINARY - OTHER
1%
URINARY FREQUENCY/URGENCY
1%
HOT FLASHES/FLUSHES
1%
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
1%
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
1%
COLITIS
1%
CARDIAC ARRHYTHMIA - OTHER
1%
CONSTITUTIONAL SYMPTOMS - OTHER
1%
DYSPHAGIA (DIFFICULTY SWALLOWING)
1%
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
1%
BLOOD/BONE MARROW - OTHER
1%
URIC ACID, SERUM-HIGH (HYPERURICEMIA)
1%
INR (INTERNATIONAL NORMALIZED RATIO OF PROTHROMBIN TIME)
1%
VENTRICULAR ARRHYTHMIA
1%
LYMPHATICS - OTHER (SPECIFY, __)
1%
FISTULA, GI
1%
PRURITUS/ITCHING
1%
WATERY EYE (EPIPHORA, TEARING)
1%
SODIUM, SERUM-HIGH (HYPERNATREMIA)
1%
SEIZURE
1%
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
1%
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)
1%
HEMORRHAGE, GI
1%
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
1%
PHOTOSENSITIVITY
1%
PULMONARY FIBROSIS (RADIOGRAPHIC CHANGES)
1%
WEIGHT GAIN
1%
PAIN - OTHER
1%
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM
1%
PULMONARY/UPPER RESPIRATORY - OTHER
1%
ALKALOSIS (METABOLIC OR RESPIRATORY)
1%
CUSHINGOID APPEARANCE (E.G., MOON FACE, BUFFALO HUMP, CENTRIPETAL OBESITY, CUTANEOUS STRIAE)
1%
SYNDROMES - OTHER (SPECIFY, __)
1%
ARTHRITIS (NON-SEPTIC)
1%
BILIRUBIN (HYPERBILIRUBINEMIA)
1%
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
1%
INFECTION WITH UNKNOWN ANC
1%
INJECTION SITE REACTION/EXTRAVASATION CHANGES
1%
GASTROINTESTINAL - OTHER
1%
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)
1%
HYPOPIGMENTATION
1%
NAIL CHANGES
100%
80%
60%
40%
20%
0%
Study treatment Arm
Consolidation Docetaxel
Observation Only
Pre-Randomization
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 one week prior to 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
Cisplatin
2013
Completed Phase 3
~1940
Radiation
2003
Completed Phase 3
~1020
5-fluorouracil
2005
Completed Phase 4
~7960
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,760 Total Patients Enrolled
Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
12 Previous Clinical Trials
1,977 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment still welcoming participants?
"According to the details hosted on clinicaltrials.gov, this research project is currently open for enrollment. It was first advertised on August 4th 2022 and its information was last updated on that same day."
Answered by AI
What safety protocols should be followed when using Radiation to treat patients?
"Our organisation gave Radiation a rating of 2 because, though there is evidence supporting its safety, it has yet to be clinically proven as an effective treatment."
Answered by AI
How many Canadian locations are currently conducting this research?
"This trial has 7 active sites that span from New york to Basking Ridge, and Middletown. To minimize commute times, it is important for participants to select the closest location available."
Answered by AI
What is the present enrollment count for this trial?
"Affirmative, the clinicaltrials.gov platform has records of this trial's open enrollment which began on August 4th 2022 and was last updated that same day. This research seeks 71 participants from 7 locations."
Answered by AI
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