Trial Summary
What is the purpose of this trial?This trial tests a treatment for head and neck cancer that uses lower doses of radiation and chemotherapy, followed by surgery to remove lymph nodes. It aims to see if this approach is effective while causing fewer side effects.
Is the drug Carboplatin a promising treatment for head and neck cancer?Yes, Carboplatin, when used with radiation therapy, shows promising results for treating head and neck cancer. It can lead to complete remission in some patients and is generally well-tolerated, with fewer side effects compared to other treatments like cisplatin.5781012
What safety data exists for reduced chemoradiation using carboplatin in head and neck cancer?Several studies have evaluated the safety of using carboplatin in chemoradiation for head and neck cancer. Carboplatin is often used as an alternative to cisplatin for patients who are ineligible for cisplatin due to age or renal, cardiac, or neurogenic dysfunction. The studies indicate that carboplatin has a different toxicity profile compared to cisplatin, with mild nausea, vomiting, and myelosuppression being the most common side effects. Importantly, carboplatin does not exhibit renal or neurologic toxicity, which allows for outpatient treatment. However, moderate bone marrow suppression is noted as the main toxicity, and care should be taken when using it in combination with other myelotoxic agents. In a phase I study, a carboplatin dose of 70 mg/m2 was found to have acceptable toxicity, with severe mucositis, nausea, vomiting, and myelosuppression being the limiting factors at higher doses. Overall, carboplatin is considered a safer alternative for patients who cannot tolerate cisplatin, with further studies recommended to fully define its safety and efficacy.123911
Do I need to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial coordinators or your doctor.
What data supports the idea that Reduced Chemoradiation for Head and Neck Cancer is an effective treatment?The available research shows that using carboplatin with radiation for head and neck cancer can be effective. One study found that this combination helps control the cancer in the local area and improves survival chances. Another study highlighted that using carboplatin instead of another drug, cisplatin, can be beneficial for patients who might have more side effects with cisplatin. Overall, combining chemotherapy with radiation seems to work better than using radiation alone, as it can improve survival rates and help preserve important functions like speech.4561011
Eligibility Criteria
This trial is for adults with specific head and neck squamous cell carcinoma (excluding certain types like nasopharyngeal or oral cavity cancers) who haven't had prior chemotherapy or radiation for it. They must have a good performance status, adequate organ function, no distant metastasis, and not be pregnant.Treatment Details
The study tests a reduced intensity of radiation and chemotherapy followed by neck dissection surgery in head and neck cancer patients. It aims to see how well the cancer responds to this less aggressive treatment approach.
1Treatment groups
Experimental Treatment
Group I: Participants with Squamous Cell Carcinoma Head and Neck CancerExperimental Treatment3 Interventions
Participants will be hypoxia-negative T0-3N1-2B small cell carcinoma head and neck cancer/SCC HNC patients (HPV-OPC, HPV- UPC with nodal metastasis(es), HPC, or LXC) who are eligible for definitive CRT with de-escalated radiation concurrent with 2 cycles of SOC chemotherapy. Hypoxia status will be determined by the absence of hypoxia radiotracer uptake on 18F-FMISO PET/CT imaging
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)Commack, NY
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, NJ
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, NY
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Phase I study of concurrent carboplatin and radiotherapy in previously untreated patients with stage III and IV head and neck cancer. [2019]This study evaluated the toxicity resulting from combined therapy using carboplatin and radiotherapy in 22 patients with locally advanced (stage III and IV) head and neck cancer. Carboplatin was given after radiotherapy during the first 5 consecutive days of a 16-fraction course of radiotherapy delivered in a total of 22 days. To find the acceptable toxic dose of carboplatin, the patients were treated in groups of 3 patients each. The first group received 50 mg/m2 carboplatin and the dose was increased by 10 mg/m2 in each subsequent group. Unacceptable toxicity (severe mucositis, nausea and vomiting, and/or myelosuppression) was encountered at a carboplatin dose of 80 mg/m2. A further 10 patients were then treated at a dose of 70 mg/m2. At this dose toxicity was acceptable. Although the group of 22 patients is too small for response and survival data to be meaningful, 10 complete responses were seen and median survival is in excess of 67 weeks.
Carboplatin, an active drug in advanced head and neck cancer. [2013]Because of the clinical activity of carboplatin in several types of tumors, this drug was studied in a phase II trial of 25 patients with advanced head and neck cancer [stage IV (M0)] without prior treatment. Six patients (24%) achieved objective response, including two patients with complete response. Carboplatin toxicity was mild in most patients, with nausea, vomiting, and myelosuppression being the most frequent side effects. No renal or neurologic toxicity was observed. Further trials of carboplatin in advanced head and neck cancer are warranted.
Carboplatin (NSC-241-240): an active platinum analog for the treatment of squamous-cell carcinoma of the head and neck. [2017]Carboplatin (CBDCA, Bristol-Meyers, New York) is a second generation platinum analog. Preclinical and phase I clinical studies have indicated a different spectrum of toxicity compared with the parent compound. In order to study the activity of carboplatin against cancer of the head and neck, 31 patients with recurrent or metastatic disease (30 squamous-cell and one adenoid cystic carcinoma) were treated with doses of 60 to 80 mg/m2 administered daily by intravenous (IV) bolus injections for five days, repeated at every 4- to 5-week intervals. In most cases, treatment was administered on an outpatient basis. Eight patients (26%; 95% confidence interval, 12% to 45%) had complete (CR) or partial responses (PR) with a median duration of 4.5 months. Moderate bone marrow suppression was the main toxicity. Mild nausea and vomiting was unusual and no neuro- or nephrotoxicity were seen. These preliminary data suggest that carboplatin has activity against advanced squamous-cell carcinoma of the head and neck comparable with the results reported with cisplatin alone in similar patient populations. The potential advantages over the parent compound relate to the absence of nephrotoxic effects and mild gastrointestinal toxicity which allows for outpatient treatment. Because carboplatin toxicity is directly dependent on its mechanism of renal excretion, particular attention should be given for its use in patients with impaired renal function or when combined with nephrotoxic agents. Similarly, because the dose limiting toxicity with this agent is primarily hematologic, its use in combination with other myelotoxic agents should be carefully undertaken. Further studies are indicated in order to define the spectrum of activity of the new generation platinum analogs in various tumors in humans.
Combined modalities in the treatment of head and neck cancers. [2015]The higher the T and N stages at diagnosis of head and neck cancer, the lower the proportion of patients who achieve complete, durable local control and the lower the survival. These cancers and their treatments often produce considerable anatomic distortion, affecting function, nutritional status, and appearance. New treatment approaches for locally and regionally advanced head and neck cancers are thus needed to improve survival, quality of life, or both. Combined-modality approaches show promise. Induction chemotherapy and subsequent radiotherapy produce results equivalent to aggressive surgery but allow for better organ function and speech. Induction chemotherapy and radiotherapy are superior to radiotherapy alone. Concurrent chemotherapy and radiotherapy may produce additive or synergistic interactions but increase toxicities. Some studies suggest that concurrent chemotherapy and radiotherapy significantly improves survival over radiotherapy alone in regionally advanced disease. Drug selection criteria have included enhancement of radiation cytotoxicity, effect on cellular kinetics, and, possibly, single-agent antitumor activity. The platinum compounds are of interest, especially in combination with other chemotherapy agents, like 5-fluorouracil and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ). Concurrent carboplatin and radiotherapy produced a 77-week duration of survival in responders in a University of Maryland Cancer Center study. A study of concurrent carboplatin/bleomycin/radiotherapy had to be halted because of severe bleomycin-induced mucositis. The results in this small group suggest that attenuating mucositis would be desirable. In a subsequent trial, paclitaxel, which shows considerable activity against head and neck cancers, was substituted for bleomycin. Data from the seven patients accrued thus far are too immature to define response. The study continues to accrue patients.
Radiation and concurrent carboplatin administration in locally advanced head and neck cancer. A Hellenic Cooperative Oncology Group Study. [2022]To improve local control in patients with locally advanced inoperable head and neck cancer we administered carboplatin concurrently with radiation.
Concurrent chemoradiation in the treatment of head and neck cancer. [2019]The concurrent use of chemotherapy with radiation in the management of head and neck cancer has been shown in several randomized studies and two recent meta-analyses to result in statistically and clinically significant gains in locoregional control and overall survival. This article highlights and summarizes the results of selected randomized studies. Concurrent single-agent chemotherapy trials, hypoxic cell sensitizer trials, and multiagent chemotherapy trials are presented. Trials employing concurrent chemoradiation in the postoperative setting, trials employing concurrent chemoradiation with an altered fractionation scheme, and promising results using concurrent chemoradiation in the previously radiated patient are presented. Current ongoing trials and future directions in concurrent chemoradiation are discussed.
Simultaneous radiochemotherapy in the treatment of inoperable, locally advanced head and neck cancers. [2013]The results of radiation therapy alone in locally advanced head and neck cancers are dismal with 5 year locoregional control rates not exceeding 15%. The addition of concomitant chemotherapy with cisplatin and more recently carboplatin has shown promising results. Twenty patients of inoperable stage III and IV oral or oropharyngeal cancers were treated with concomitant chemoradiation with carboplatin 300 mg/m2 i.v. on days 1, 21 and 42 of radiation therapy. Twelve (60%) patients had a complete remission. Thirteen patients were alive at a median follow up of 11 months. The treatment was well tolerated with only 2 patients requiring treatment interruptions for mucositis. Longer follow up would reveal any improvement in overall survival. The relative ease with which carboplatin/RT was administered suggests that other agents might be added as well.
The role of concurrent chemo-radiotherapy in patients with head and neck cancers: a review. [2012]Concurrent chemo-radiotherapy has become the standard treatment for patients with locally advanced head and neck cancers. In surgically operated patients post-operative concurrent chemo-radiotherapy is the standard of care. For organ/speech preservation and in patients who are not surgically operable the standard of care is concurrent chemo-radiotherapy. In patients with locally advanced NPC although concurrent chemo-radiotherapy was superior to RT only, the standard of care is concurrent chemo-radiotherapy followed by three courses of adjuvant combination chemotherapy. Single daily fraction irradiation is the standard of care when given concomitant with chemotherapy. Although, single agent cisplatin given on every three weeks schedule is the standard of care, this could be replaced safely and as effectively with weekly carboplatin given with RT with much less side effects and with similar efficacy.
Safety and efficacy of concurrent carboplatin plus radiotherapy for locally advanced head and neck cancer patients ineligible for treatment with cisplatin. [2018]Cisplatin-based chemoradiotherapy is the standard treatment for patients with locally advanced squamous cell carcinoma of the head and neck. However, patients with advanced age, renal, cardiac or neurogenic dysfunction seem ineligible for cisplatin treatment. We evaluated the safety and efficacy of concurrent carboplatin plus radiotherapy in patients ineligible for cisplatin usage.
Definitive chemoradiotherapy for squamous head and neck cancer: cisplatin versus carboplatin? A meta-analysis. [2017]Concomitant chemoradiotherapy (with cisplatin or carboplatin) is an option of definitive treatment for squamous head and neck cancer. We aimed to perform a meta-analysis comparing those two platinum agents.
Definitive chemoradiotherapy with carboplatin for squamous cell carcinoma of the head and neck. [2019]Definitive concurrent chemoradiotherapy (CRT) is considered the standard of care for organ preservation and is the only potentially curative therapy for surgically unresectable patients with stage III to IVb locally advanced squamous cell carcinoma of the head and neck. In patients with high risks for adverse events utilizing cisplatin, carboplatin has been empirically substituted. The objective of this study was to estimate the locoregional control rate, progression-free survival, overall survival, and adverse events in locally advanced squamous cell carcinoma of the head and neck patients treated with CRT utilizing carboplatin.
Cisplatin Every 3 Weeks Versus Weekly With Definitive Concurrent Radiotherapy for Squamous Cell Carcinoma of the Head and Neck. [2020]Concurrent chemoradiotherapy is an established component of the nonoperative management of locally advanced head and neck squamous cell carcinoma (HNSCC), but the standard dose of 100 mg/m2 cisplatin every 3 weeks is associated with clinically significant toxicity. Interest in a more tolerable regimen has led to the widespread use of weekly lower dose cisplatin, but few randomized trials have compared these approaches.