Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemora… (NCT03515538) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers
United States53 participantsStarted 2018-07-12
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 duration or length 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 in arms 1, 2 and 3 will also receive RRx-001 on different schedules.
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 and oropharynx Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criterion #3 below are eligible for the trial
✓. Treatment planned to include standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) with concomitant radiation delivered as a continuous course of IMRT with single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) 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 has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test for patients with cancers of the oropharynx, base of tongue, or unknown primary.
✓. 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
Duration of Severe Oral Mucositis (SOM)
Timeframe: From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment
✕. Tumor of the lips, nasopharynx, hypopharynx, larynx, or salivary glands
✕. Patients with simultaneous primaries or bilateral tumors
✕. Metastatic disease (M1) Stage IV
✕. Malignant tumors other than HNC within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator
✕. Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at study entry
✕. Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal diet
✕. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason