121 Participants Needed

Reduced Radiation + Chemotherapy for Throat Cancer

Recruiting at 7 trial locations
HS
NL
Overseen ByNancy Lee, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

What data supports the effectiveness of the drug combination of reduced radiation, 5-fluorouracil, and platinum-based chemotherapy for throat cancer?

Research shows that combining chemotherapy drugs like cisplatin and 5-fluorouracil with radiation can improve survival rates in advanced head and neck cancers compared to radiation alone. Carboplatin, a similar drug to cisplatin, is noted for having less toxicity, making it a potentially effective alternative in combination treatments.12345

Is the combination of reduced radiation and chemotherapy safe for throat cancer treatment?

The combination of carboplatin and 5-fluorouracil (5-FU) is generally considered to have a more favorable safety profile compared to cisplatin and 5-FU, with less severe side effects like nausea, vomiting, and kidney issues. While some side effects like low blood cell counts and mild kidney problems can occur, they are usually manageable and reversible.16789

How is the reduced radiation and chemotherapy treatment for throat cancer different from other treatments?

This treatment combines reduced radiation with chemotherapy drugs like 5-fluorouracil, carboplatin, and cisplatin, aiming to lower toxicity while maintaining effectiveness. Carboplatin is used instead of cisplatin in some cases due to its less severe side effects, and the combination with radiation is designed to enhance the treatment's cancer-fighting ability.15101112

What is the purpose of this trial?

The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).

Research Team

Nancy Y. Lee, MD, FASTRO - MSK ...

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My throat cancer is caused by HPV.
Study-specific informed consent prior to study entry
I cannot tolerate certain chemotherapy drugs and will receive specific alternatives.
See 9 more

Exclusion Criteria

I have received chemotherapy for my current cancer.
Severe, active co-morbidity as defined
I have liver problems causing jaundice or blood clotting issues.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy of carboplatin, paclitaxel with or without cetuximab for 6 weeks

6 weeks

Radiation and Concurrent Chemotherapy

Participants receive reduced radiation therapy concurrent with chemotherapy drugs such as cisplatin, carboplatin, and 5-fluorouracil (5-FU), paclitaxel, or Abraxane

Duration not specified

Follow-up

Participants are monitored for locoregional control and recurrence for 2 years

2 years

Treatment Details

Interventions

  • 5-fluorouracil
  • Carboplatin
  • Cisplatin
  • Radiation
Trial Overview 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.
Participant Groups
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)

5-fluorouracil is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Esophageal cancer
  • Anal cancer
🇪🇺
Approved in European Union as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Esophageal cancer
  • Anal cancer
🇨🇦
Approved in Canada as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Esophageal cancer
  • Anal cancer
🇯🇵
Approved in Japan as 5-FU for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Esophageal cancer
  • Anal cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

In a phase II trial involving 32 patients with recurrent or metastatic head and neck squamous cell carcinoma, the combination of carboplatin and raltitrexed demonstrated moderate efficacy, with a 22% partial response rate and a median survival duration of 9.8 months.
The treatment was generally safe, with manageable toxicity; however, 25% of patients experienced severe neutropenia, and one patient dropped out due to persistent hepatic toxicity, indicating the need for monitoring during treatment.
Carboplatin in combination with raltitrexed in recurrent and metastatic head and neck squamous cell carcinoma: A multicentre phase II study of the Gruppo Oncologico Dell'Italia Meridionale (G.O.I.M.).Galetta, D., Giotta, F., Rosati, G., et al.[2014]
In a study of 51 patients with HPV-related oropharyngeal squamous cell carcinoma, one course of TPF chemotherapy resulted in a high partial response rate of 73%, indicating its potential effectiveness in predicting outcomes for subsequent chemoradiotherapy.
The study found that 85% of patients who underwent chemoradiotherapy achieved a complete response, with a 2-year survival rate of 92%, suggesting that TPF can help guide treatment decisions between chemoradiotherapy and surgery.
Predicting the efficacy of chemoradiotherapy for locally advanced human papilloma virus-related oropharyngeal squamous cell carcinoma using one course of TPF chemotherapy.Kondo, T., Tsukahara, K., Okamoto, I., et al.[2021]
Higher T and N stages in head and neck cancer are associated with lower rates of complete local control and survival, highlighting the need for improved treatment strategies.
Combined-modality treatments, such as induction chemotherapy followed by radiotherapy, show promise in enhancing survival and preserving organ function compared to aggressive surgery or radiotherapy alone.
Combined modalities in the treatment of head and neck cancers.Aisner, J., Hiponia, D., Conley, B., et al.[2015]

References

Carboplatin in combination with raltitrexed in recurrent and metastatic head and neck squamous cell carcinoma: A multicentre phase II study of the Gruppo Oncologico Dell'Italia Meridionale (G.O.I.M.). [2014]
Predicting the efficacy of chemoradiotherapy for locally advanced human papilloma virus-related oropharyngeal squamous cell carcinoma using one course of TPF chemotherapy. [2021]
Combined modalities in the treatment of head and neck cancers. [2015]
Randomized trial of neoadjuvant cisplatin and fluorouracil versus carboplatin and fluorouracil in patients with stage IV-M0 head and neck cancer. [2017]
[Docetaxel and squamous cell carcinoma of the head and neck]. [2018]
Carboplatin. The better platinum in head and neck cancer? [2019]
Chemotherapy following surgery for head and neck cancer. A Radiation Therapy Oncology Group Study. [2019]
Phase II trial of carboplatin and tegafur (Ftorafur) as induction therapy in squamous-cell carcinoma of the head and neck. [2019]
[Results of a phase II study with the new cytostatic drug carboplatin in combination with 5-fluorouracil in the primary treatment of advanced squamous cell cancers of the head and neck]. [2013]
Alteration of chemotherapy (cisplatin and 5-FU) and radiotherapy in the management of advanced or recurrent head and neck cancer: a phase II study. [2013]
Survival outcomes in patients with oropharyngeal cancer treated with carboplatin/paclitaxel and concurrent radiotherapy. [2018]
Comparison of carboplatin-paclitaxel to docetaxel-cisplatin-5-flurouracil induction chemotherapy followed by concurrent chemoradiation for locally advanced head and neck cancer. [2021]
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