Reduced-Dose Radiation Therapy for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
Disqualifiers: Prior head and neck cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This research study is studying lowering the standard dose of radiation and chemotherapy after surgery, to minimize the side effects and improve the quality of life.
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 De_Intensified Postoperative Radiation Therapy for head and neck cancer?
Research suggests that reducing treatment intensity in selected patients with head and neck cancer may improve overall survival without increasing side effects. Additionally, combining chemotherapy with radiation therapy has shown improved survival in patients with advanced head and neck cancer.
12345Is reduced-dose radiation therapy for head and neck cancer safe?
Research on deintensified radiation therapy for head and neck cancer, such as the AVOID trial, has focused on safety and effectiveness, indicating it is generally safe for humans. However, specific side effects and tolerance can vary, and it's important to discuss individual risks with a healthcare provider.
56789How is De-Intensified Postoperative Radiation Therapy different from other treatments for head and neck cancer?
De-Intensified Postoperative Radiation Therapy is unique because it reduces the radiation dose to minimize side effects on the swallowing apparatus and salivary glands, which can improve quality of life for patients compared to standard high-dose radiation treatments.
510111213Eligibility Criteria
This trial is for adults who've had surgery for HPV-related squamous cell carcinoma of the throat, with a history of light or no smoking (≤20 pack-years), good performance status, and no prior head and neck cancer or radiation. They must have normal organ function and no serious illnesses that could affect study participation.Inclusion Criteria
Ability to understand and the willingness to sign a written informed consent document.
My cancer is a type of throat cancer that's p16 positive.
absolute neutrophil count ≥1,000/mcL
+20 more
Exclusion Criteria
I am not pregnant or breastfeeding if I want to join this study.
I do not have any serious illnesses that would stop me from following the study's requirements.
I have had radiation therapy on my head or neck before.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive reduced-dose radiation or observation based on risk level
6-8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Quality of Life Assessment
Assessment of physical, social/family, emotional, and functional wellbeing
2 years
Participant Groups
The study tests whether a lower dose of postoperative radiation therapy can reduce side effects while still being effective against HPV-associated oropharyngeal squamous cell carcinoma. It aims to improve quality of life after treatment.
3Treatment groups
Experimental Treatment
Group I: Low RiskExperimental Treatment1 Intervention
Observation without adjuvant therapy
* Pathologic T0-2, N0-1
* Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck
* Single positive lymph node up to 3cm
* No extranodal extension
* Clear margins
* Undetectable postoperative circulating tumor HPV DNA
Group II: Intermediate RiskExperimental Treatment1 Intervention
Reduced-dose radiation (46Gy)
* Pathologic T0-2N0-2 and any one of the following features:
* 2 or more positive lymph nodes
* single node \>3cm
* \<15 lymph nodes retrieved on neck dissection for each side of the neck
* Positive lymph nodes in level IB, IV, or V
-≤1mm extranodal extension
* Positive lymph node(s) contralateral to the primary tumor
* Close margins
* Detectable postoperative circulating tumor HPV DNA
Group III: High RiskExperimental Treatment1 Intervention
Postoperative radiation (60Gy) without chemotherapy
* Pathologic T0-4N0-2 and any one of the following features:
-\>1mm extranodal extension
* Microscopic positive margins
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
References
Split course hyperfractionated accelerated radio-chemotherapy (SCHARC) for patients with advanced head and neck cancer: influence of protocol deviations and hemoglobin on overall survival, a retrospective analysis. [2019]The advantage of hyperfractionated accelerated radiation therapy for advanced head and neck cancer has been reported. Furthermore, randomized trials and meta-analyses have confirmed the survival benefit of additional chemotherapy to radiotherapy. We retrospectively analyzed the efficiency and toxicity of the Regensburg standard therapy protocol "SCHARC" and the overall survival of our patients.
Postoperative radiotherapy for head and neck squamous cell carcinomas: feasibility of a biphasic accelerated treatment schedule. [2019]It has been suggested that postoperative tumor cell proliferation may influence the outcome of advanced head and neck squamous cell carcinomas treated by surgery and postoperative radiotherapy. This Phase I pilot study was undertaken to determine the feasibility of a biphasic accelerated radiotherapy regimen with early and late concomitant boost delivery for postoperative treatment of patients with advanced head and neck cancers.
Optimising the therapeutic ratio in head and neck cancer. [2022]The intensity of contemporary treatment for locally advanced head and neck cancer is at the upper limit of human tolerance of acute toxicities. While impressive gains in locoregional control have been achieved, improvements in overall survival have been more modest. We hypothesise that unrecognised sequelae of highly toxic contemporary treatments substantially contribute to patient mortality. This possibility provides motivation to investigate reducing treatment intensity in selected patients with locally advanced head and neck cancer. With the demonstration of a good prognosis among subgroups of patients with head and neck cancer, major improvements in the technical delivery of radiotherapy, and further research into relevant factors in survivorship, we may be able to improve overall survival of patients with locally advanced disease without further increasing, and possibly reducing, treatment intensity.
[IMRT and head and neck tumors: does differential fractionation have a role?]. [2018]For head and neck cancer, intensity-modulated radiation therapy (IMRT) provides benefits in terms of coverage of the target tumour volume and reduction of the dose to organs at risk. Altered fractionation called SMART (simultaneous modulated accelerated radiation therapy) or SIB (simultaneous integrated boost), equivalent to the "concomitant boost" of conventional techniques, provides additional theoretical gain in the therapeutic index and simplifies the practical implementation of the treatment. The impact on tumour control and acute and late toxicities is encouraging but needs to be confirmed by prospective clinical studies with sufficient follow-up. A lot of different protocols have been tested without really bringing out a "gold standard". However, the current results tend to suggest a SIB/SMART-IMRT moderately accelerated without combined chemotherapy for limited stages (I and II), and SIB-IMRT slightly accelerated with induction and/or concomitant chemotherapy for more advanced stages (III and IV).
Adjuvant therapy in patients with resected poor-risk head and neck cancer. [2013]In patients with locally or regionally advanced head and neck carcinomas, postoperative radiotherapy has historically been the adjuvant therapy applied for patients with prognostically worrisome pathologic features. Any improvement in therapeutic index achieved by adding cytotoxic agents to postoperative radiotherapy remained controversial. However, two recent randomized trials, conducted in parallel in Europe and the United States, produced level I evidence regarding improved efficacy in this setting for the concurrent administration of chemotherapy and radiotherapy. High-dose cisplatin and irradiation can now be considered the standard therapeutic approach for resected poor-risk disease. The presence of positive margins and/or nodal extracapsular spread in the surgical specimens are the subgroups that appear to benefit in the most significant way from the addition of chemotherapy to radiation. Many questions regarding the optimization of adjuvant treatments still remain unanswered, especially with respect to improvement of patient compliance, integration of novel drugs targeting both locoregional and systemic control, and modulation of treatment intensity according to risk levels.
A Phase 2 Trial of Alternative Volumes of Oropharyngeal Irradiation for De-intensification (AVOID): Omission of the Resected Primary Tumor Bed After Transoral Robotic Surgery for Human Papilloma Virus-Related Squamous Cell Carcinoma of the Oropharynx. [2020]This trial tested the safety and efficacy of a novel, deintensified radiation therapy (RT) approach after initial surgical resection for patients with human papilloma virus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC).
Concomitant boost chemoradiotherapy in locally advanced head and neck cancer: treatment tolerance and acute side effects. [2015]In the present study, we evaluated treatment tolerance and side effects of 6 days a week accelerated radiation therapy using concomitant boost methods with chemotherapy in locally advanced head and neck cancer.
Phase II trial of a simultaneous radiochemotherapy with cisplatinum and paclitaxel in combination with hyperfractionated-accelerated radiotherapy in locally advanced head and neck tumors. [2022]Simultaneous radiochemotherapy (RCT) is the treatment of choice for locally advanced head and neck cancers. In order to evaluate the toxicity and the survival rates, we investigated the use of a very aggressive combination protocol that included cisplatinum and paclitaxel combined with hyperfractionated-accelerated radiotherapy. The final results of the phase II study are listed below.
A phase II study of concomitant boost radiation plus concurrent weekly cisplatin for locally advanced unresectable head and neck carcinomas. [2013]This phase II study evaluated the efficacy and toxicity of weekly cisplatin along with concomitant boost accelerated radiation regimen in patients with locally advanced unresectable head and neck carcinoma.
Dose Reduction to the Swallowing Apparatus and the Salivary Glands by De-Intensification of Postoperative Radiotherapy in Patients with Head and Neck Cancer: First (Treatment Planning) Results of the Prospective Multicenter DIREKHT Trial. [2020]Evaluating radiotherapy treatment plans of the prospective DIREKHT trial (ClinicalTrials.gov, NCT02528955) investigating de-intensification of radiotherapy in patients with head and neck cancer.
DAHANCA 28: A phase I/II feasibility study of hyperfractionated, accelerated radiotherapy with concomitant cisplatin and nimorazole (HART-CN) for patients with locally advanced, HPV/p16-negative squamous cell carcinoma of the oropharynx, hypopharynx, larynx and oral cavity. [2021]A phase I-II study to evaluate the feasibility and efficacy of intensified, primary radiotherapy (RT) for Locally Advanced Head and Neck Squamous Cell Carcinoma (LAHNSCC) employing dose escalation by hyperfractionation, acceleration of treatment time, concomitant chemotherapy and hypoxic modification.
Adjuvant postoperative external beam radiotherapy in head and neck cancer. [2019]The optimum postoperative dose for local or regional disease control was retrospectively assessed in 70 patients with head and neck cancer given adjuvant external beam radiotherapy. Actuarial 2-year survival rates with no evidence of disease (NED) according to stage were 75%, 59%, and 72% for stages II, III, and IV, respectively. Primary tumor/regional failure and distant metastasis adversely affected prognosis. Patients had an actuarial 2-year NED of 80% when the dose to the primary tumor/upper neck was greater than or equal to 60 Gy but was 53% when the dose was less than 60 Gy. Two-year NED was 85% in those patients given greater than 50 Gy to the lower neck and 62% when less than or equal to 50 Gy was used. Based on these results, a total dose of at least 60 Gy to the primary tumor bed and upper neck and greater than 50 Gy to the lower neck whenever adjuvant postoperative irradiation is administered for subclinical disease is recommended.
[Adjuvant treatment of head and neck cancers: advances and challenges]. [2011]Following the release, in 2004, of the results from 2 multicentric, phase III studies, the adjuvant treatment of locally advanced head-and-neck cancers nowadays belongs to Level I of Evidence-Based Medicine, with the advent of concomitant, high-dose chemoradiation. The concurrent delivery of radiotherapy (60 to 66 Gy using a conventional fractionation) and high-dose, bolus cisplatin (100 mg/m2, days 1, 22 and 43) is considered, in post-operative setting, as the standard approach in patients with locally advanced disease. Future adjuvant treatments should anchor to the development of high-precision irradiation techniques, as well as concomitant delivery of radiotherapy with more efficacious cytotoxic drugs and/or targeted therapies.