RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and… (NCT05966194) | Clinical Trial Compass
RecruitingPhase 2
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
United States216 participantsStarted 2024-04-02
Plain-language summary
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity or oropharynx Note: Patients with primary cancers that are presumed to be of oropharyngeal origin may be included if they meet radiation field dosing criteria as specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are acceptable. HPV determination must be made for all patients.
✓. Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to 2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or adjuvant chemotherapy. Planned radiation treatment fields must include at least two oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each planned to receive a total of \> 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
✓. ECOG performance status ≤ 2.
✓. Participants must have adequate organ and marrow function as defined below:
✓. Adequate renal and liver function as indicated by:
✓. Human papilloma virus (HPV) status in tumor must be documented using tumor immunohistochemistry for HPV-p16 or other accepted test (such as such as in situ hybridization) for patients with cancers of the oropharynx (Rooper et al, 2016, Martens 2017). HPV status at baseline optional for oral cavity tumors.
✓. Age 18 years or older
✓. Patient must consent to the access, review, and analysis of previous medical and cancer history, including imaging data, by the sponsor or a third party nominated by the sponsor.
Exclusion criteria
What they're measuring
1
Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT)
✕. Prior radiotherapy to the head and neck region.
✕. Prior induction chemotherapy.
✕. Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
✕. Patients with simultaneous primaries
✕. Stage IV, M1 (distant metastasis)
✕. Prior or current use of approved or investigational anticancer agent other than those provided in this study.
✕. Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal (solid) diet
✕. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason or prophylactic insertion of gastrostomy tube with dependency on tube feeding at baseline.