Reduced Intensity Chemo for Oropharyngeal Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: NYU Langone Health
Disqualifiers: Diabetes, Pregnancy, AIDS, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This will be a phase II single-arm clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment for oropharyngeal cancer?
Research shows that using cisplatin (a chemotherapy drug) with radiation therapy can be effective for treating advanced oropharyngeal cancer, and de-escalating (reducing) the dose and volume of treatment can lead to better functional outcomes for patients with HPV-positive oropharyngeal cancer.12345
Is reduced intensity chemo for oropharyngeal cancer safe for humans?
Research shows that using cisplatin (a type of chemotherapy) with radiation is generally safe for treating head and neck cancers, including oropharyngeal cancer. Common side effects include blood-related issues and gastrointestinal problems, but serious kidney, ear, or nerve damage was not observed. Reduced-dose chemoradiation may also lower the risk of severe side effects compared to standard doses.16789
How does the treatment of reduced intensity chemo with cisplatin and radiation differ from other treatments for oropharyngeal cancer?
This treatment uses a reduced intensity approach by combining cisplatin (a chemotherapy drug) with standard radiation, potentially offering a balance between effectiveness and reduced side effects compared to high-dose regimens. It aims to maintain efficacy while minimizing toxicity, which is particularly beneficial for patients with other health issues.19101112
Research Team
Kenneth S. Hu
Principal Investigator
NYU Langone Health
Eligibility Criteria
This trial is for adults with HPV-positive oropharyngeal cancer confirmed by p16 staining and detectable HPV DNA in the blood. They should have a specific stage of cancer (T1-T2, N1-N2b or T3, N1-N2b), no more than 10 pack-years of smoking history, good performance status, adequate organ function, and no prior allergic reaction to cisplatin. Pregnant women and those with certain health conditions like unstable heart disease or severe infections are excluded.Inclusion Criteria
My cancer is a type of throat cancer called squamous cell carcinoma.
Detectable circulating plasma HPV DNA at baseline
Specific imaging requirements within 8 weeks of registration
See 9 more
Exclusion Criteria
Pregnancy
Exclusion Criteria for MRI including specific conditions
I have a neck cancer with an unknown starting point, even if it's p16 positive.
See 9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive standard radiation therapy and cisplatinum, with treatment de-escalation based on mid-treatment tumor response
6-8 weeks
Follow-up
Participants are monitored for safety, effectiveness, and late toxicity after treatment
2 years
Treatment Details
Interventions
- Cisplatinum (Alkylating agents)
- Dose-Deescalated Treatment (Radiation)
- Standard Radiation Treatment (Radiation)
Trial OverviewThe study tests if lowering the dose of chemoradiation treatment based on how well tumors respond mid-treatment can be effective. It's a phase II trial focusing on patients' progression-free survival over two years using standard radiation combined with Cisplatinum chemotherapy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: HPV-Positive Oropharyngeal Carcinoma (OPSCC)Experimental Treatment3 Interventions
Standard radiation therapy + cisplatinum
Cisplatinum is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Platinol for:
- Testicular cancer
- Ovarian cancer
- Lung cancer
- Bladder cancer
- Cervical cancer
🇺🇸 Approved in United States as Platinol for:
- Metastatic testicular tumors
- Metastatic ovarian tumors
- Advanced bladder cancer
🇨🇦 Approved in Canada as Cisplatin for:
- Metastatic testicular cancer
- Advanced ovarian cancer
- Bladder cancer
🇯🇵 Approved in Japan as CDDP for:
- Testicular cancer
- Ovarian cancer
- Lung cancer
- Bladder cancer
- Cervical cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New York University School of MedicineNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
Trials
1431
Patients Recruited
838,000+
References
Comparing outcomes of concurrent chemotherapy regimens in patients 65 years old or older with locally advanced oropharyngeal carcinoma. [2023]The comparative efficacy of cisplatin (CDDP), carboplatin, and cetuximab (CTX) delivered concurrently with radiation for locally advanced oropharyngeal squamous cell carcinoma continues to be evaluated.
Concomitant chemoradiation versus radical radiotherapy in advanced squamous cell carcinoma of oropharynx and nasopharynx using weekly cisplatin: a phase II randomized trial. [2022]To know the effectiveness and tolerance of weekly cisplatin added to radiotherapy (RT) in advanced carcinoma of oropharynx and nasopharynx.
Radiotherapy with concomitant weekly docetaxel for Stages III/IV oropharynx carcinoma. Results of the 98-02 GORTEC Phase II trial. [2019]We designed a prospective Phase II clinical trial to evaluate the addition of weekly chemotherapy using Docetaxel during standard radiation therapy in patients with Stages III and IV oropharynx carcinoma.
Dose and Volume De-Escalation for Human Papillomavirus-Positive Oropharyngeal Cancer is Associated with Favorable Posttreatment Functional Outcomes. [2021]To report functional outcomes for patients with human papillomavirus-positive oropharyngeal cancer treated on a phase 2 protocol of risk- and induction chemotherapy response-adapted dose and volume de-escalated radiation therapy (RT)/chemoradiation (CRT).
Efficacy of targeted chemoradiation and planned selective neck dissection to control bulky nodal disease in advanced head and neck cancer. [2019]To determine the efficacy of targeted chemoradiation with the radiation plus platinum (RADPLAT) protocol and planned selective neck dissection in patients with N2 to N3 nodal disease associated with upper aerodigestive tract carcinoma.
Analysis of Risk Factors for High-dose Cisplatin-induced Renal Impairment in Head and Neck Cancer Patients. [2022]Concurrent chemoradiotherapy with high-dose cisplatin (CDDP-RT) is the standard therapy for advanced head and neck cancer; however, due to CDDP-induced renal impairment, dose reduction or discontinuation is frequently required. Therefore, the identification of risk factors for renal impairment is of importance to improve the efficacy and safety of CDDP-RT.
Standard of care vs reduced-dose chemoradiation after induction chemotherapy in HPV+ oropharyngeal carcinoma patients: The Quarterback trial. [2020]Human Papillomavirus oropharyngeal carcinoma (HPVOPC) has better progression free (PFS) and overall survival (OS) than non-HPVOPC. Standard-dose chemoradiotherapy (sdCRT) results in significant acute toxicity and late morbidity. We hypothesized that after induction chemotherapy (IC), reduced dose chemoradiation (rdCRT) would result in equivalent PFS and OS compared to sdCRT plus IC in HPVOPC and would reduce toxicity.
Simultaneous cis-platinum and radiotherapy in inoperable or locally advanced squamous cell carcinoma of the head and neck. [2018]A synergism between cis-platinum (CDDP) and radiotherapy (RT) has been demonstrated both in culture systems and in clinical studies. On the above basis, we planned, in patients with locally advanced or unresectable squamous cell carcinoma of the head and neck, a concomitant treatment with CDDP 80 mg/m2 i.v. every 3 weeks for three doses (days 1, 21 and 42) and RT in the primary and in the neck nodes bilaterally, for a total dose of 60-70 Gy. Thirty-five untreated patients with poor prognosis unresectable stage II and stages III-IV disease were entered in the study and 32 were evaluable. Complete response (CR) rate was 75% (24/32) with 95% confidence limits from 60 to 90% (+/- 15%): 8 cases (25%) achieved a partial response, for an overall response rate of 100%. A significantly higher CR rate and a longer survival rate was observed in patients with good performance status (PS = 90-100) and stages II-III. The overall estimated 2-year survival is 46%; 59% for patients who obtained a CR versus 0% for those who achieved only a partial response. Overall the treatment was well tolerated and gastrointestinal and hematologic toxicities were the most common side effects. In conclusion, the combination of CDDP plus RT is a very effective and safe treatment and we recommend such an approach in head and neck squamous cell carcinoma, particularly in those patients with good PS and with unresectable stage II or stage III disease.
Radiotherapy with concomitant continuous cisplatin infusion for unresectable tumors of the upper aerodigestive tract: results of a phase I study. [2019]A phase I-II study was initiated in February 1991 of concomitant radiation and cisplatin (CDDP) in the treatment of unresectable head and neck squamous cell carcinomas (n = 12). The first patient was treated palliatively for a cervical recurrence of laryngeal cancer. The 11 other patients had locally advanced (stage IV) previously untreated carcinomas of the oropharynx (n = 9), hypopharynx (n = 1), or cervical node with unknown primary site (n = 1). Standard external radiation was carried out up to a total dose of 60 Gy/6 weeks (7 MeV electron beam) for the first patient and 72 Gy/8 weeks (Co60 beam) for the other 11 patients. CDDP was infused continuously during the entire radiation treatment, 5 days/week. The starting dose was 4 mg/m2/day and was escalated by increments of 1 mg/m2/day; dose-limiting toxicity was observed at 7 mg/m2/day. Neutropenia (grade 4, one patient; grade 3, three patients) and thrombocytopenia (grade 3, one patient; grade 2, one patient) were the limiting factors. Therefore, the recommended dose of CDDP is 6 mg/m2/day. All patients but one completed the scheduled radiation. For the entire group, mucositis was not more severe than that observed with radiotherapy alone. There was no nephro-, oto-, or neurotoxicity. A complete response was obtained in eight (66%) patients. Of these, four were free of disease 12-34 months after completion of treatment and one had a total glossectomy for a tongue necrosis. For the whole series, the mean overall survival was 16 months posttreatment. Pharmacokinetic analysis indicated the total cisplatin accumulation at the end of treatment to be 743-1551 ng/ml. Accumulation of ultrafilterable platin was noted in only one patient (137 ng/ml at the end of treatment).
Patterns of relapse following definitive treatment of head and neck squamous cell cancer by intensity modulated radiotherapy and weekly cisplatin. [2019]Eighty-three patients with oropharyngeal, hypopharyngeal or laryngeal cancer were treated with concomitant cisplatin 40 mg/m(2) once a week during the radiotherapy and IMRT up to a total dose of 70 Gy. The 2-year rate of local control, overall survival and disease specific survival were 84%, 82% and 89%, respectively. The corresponding 5-year Kaplan-Meier estimates were 79%, 69% and 76%.
Adjuvant chemoradiation therapy with high-dose versus weekly cisplatin for resected, locally-advanced HPV/p16-positive and negative head and neck squamous cell carcinoma. [2022]Standard treatment for patients with poor-risk, resected head and neck squamous cell carcinoma (HNSCC) is adjuvant radiation therapy combined with high-dose cisplatin. Many patients are treated with weekly cisplatin; it is not known whether weekly and high-dose cisplatin are equivalent. This study compares the outcomes of patients with locally-advanced HPV-negative HNSCC and HPV/p16-positive oropharynx HNSCC treated with adjuvant chemoradiation therapy with either high-dose or weekly cisplatin.
Deployment of cisplatin in Veterans with oropharyngeal cancer: toxicity and impact on oncologic outcomes. [2023]Cisplatin forms the backbone of systemic chemotherapy treatment for oropharyngeal squamous cell carcinoma (OPSCC). The ideal cisplatin dosing regimen remains yet to be fully defined for achieving optimal efficacy and toxicity profiles in patients with comorbidity.