Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Stomatitis

Mucositis

Mouth Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin

Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration

Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration

No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7).

RRx-001

Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients

Cisplatin for injection

Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study

Radiation Therapy

Bryan Oronsky, MD, PhD

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.

The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there is only one approved therapy to treat or prevent it.

Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

A Phase 2a Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Duration in days of severe oral mucositis (SOM). Defined as oral mucositis grade 3 or 4 on the WHO Mucositis Grading Scale which comprises 5 grades: 0 = none, 1=oral soreness, erythema, 2=oral erythema, ulcers, solid diet tolerated, 3=oral ulcers, liquid diet only, and 5=oral alimentation impossible. Sever Oral Mucositis duration is obtained by totaling the number of days a given patient experiences oral mucositis grade 3 or 4 during the randomized treatment period. Higher Sever Oral Mucositis duration numbers are indicative of worst outcomes. The total Sever Oral Mucositis duration for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.

Time to onset of Sever Oral Mucositis defined as time (in days) from randomization to the first observed Sever Oral Mucositis. Longer Sever Oral Mucositis onset times are indicative of a better outcome. The time to onset of Sever Oral Mucositis for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.

Incidence of Sever Oral Mucositis defined as the proportion of patients experiencing Sever Oral Mucositis during the randomized treatment period. Sever Oral Mucositis incidence range is 0 to 100%, and higher percentages are indicative of worse outcomes.

Duration (in days) of ulcerative oral mucositis defined as the proportion of patients experiencing oral mucositis during the randomized treatment period. Defined as oral mucositis grade 0 or 1 on the WHO Mucositis Grading Scale (described above). Longer duration of ulcerative oral mucositis is indicative of a worse outcome. The total ulcerative oral mucositis duration for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.

Incidence of ulcerative oral mucositis defined as the proportion of patients experiencing ulcerative oral mucositis during the randomized treatment period. Ulcerative oral mucositis is defined as oral mucositis grade 0 or 1 on the WHO Mucositis Grading Scale (described above) and ranges from 0 to 100% with higher percentages being indicative of worse outcomes.

Patient-reported mouth and throat soreness score obtained from Question #2 from the Oral Mucositis Daily Questionnaire (OMDQ) filled out by the patient. OMDQ Question #2 asked "During the last 24 hours, how much mouth and throat soreness did you have?". OMDQ Question # 2 uses the following five-point categorical scale to quantity mouth and throat soreness: 0=no soreness, 1=a little soreness, 2=moderate soreness, 3=quite a lot of soreness and 4=extreme soreness. Higher mouth and throat soreness values are indicative of worse outcomes. The range of the month and throat values is 0, 1, 2, 3, 4.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers	NCT03515538	Oral Mucositis	RRx-001 Cisplatin for i... Radiation Thera...	18 Years -	EpicentRx, Inc.
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers	NCT03515538	Oral Mucositis	RRx-001 Cisplatin for i... Radiation Thera...	18 Years -	EpicentRx, Inc.
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers	NCT03515538	Oral Mucositis	RRx-001 Cisplatin for i... Radiation Thera...	18 Years -	EpicentRx, Inc.

Spots Global Cancer Trial Database for sores

Every month we try and update this database with for sores cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sores

Every month we try and update this database with for sores cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sores cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.