CLINICAL TRIAL

3-Dimensional Conformal Radiation Therapy for Carcinoma

Waitlist Available · 18+ · All Sexes · Cleveland, OH

This study is evaluating the side effects and best dose of methoxyamine when given together with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage IIIA-IV non-small cell lung cancer.

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About the trial for Carcinoma

Eligible Conditions
Stage III Non-Small Cell Lung Cancer AJCC v7 · Stage IIIB Non-Small Cell Lung Cancer AJCC v7 · Stage IIIB Lung Adenocarcinoma AJCC v7 · Carcinoma · Adenocarcinoma of Lung · Adenocarcinoma · Stage IIIA Lung Large Cell Carcinoma AJCC v7 · Stage III Lung Adenocarcinoma AJCC v7 · Stage IIIA Lung Adenocarcinoma AJCC v7 · Stage IV Non-Small Cell Lung Cancer AJCC v7 · Carcinoma, Large Cell · Stage IV Lung Large Cell Carcinoma AJCC v7 · Stage III Lung Large Cell Carcinoma AJCC v7 · Stage IV Lung Adenocarcinoma AJCC v7 · Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma · Stage IIIB Lung Large Cell Carcinoma AJCC v7 · Stage IIIA Non-Small Cell Lung Cancer AJCC v7

Treatment Groups

This trial involves 2 different treatments. 3-Dimensional Conformal Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cisplatin
DRUG
Methoxyamine Hydrochloride
DRUG
Pemetrexed
DRUG
3-Dimensional Conformal Radiation Therapy
RADIATION
Pemetrexed Disodium
DRUG
Intensity-Modulated Radiation Therapy
RADIATION
Methoxyamine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Pemetrexed
FDA approved
3-Dimensional Conformal Radiation Therapy
2005
Completed Phase 3
~6740
Pemetrexed
FDA approved
Intensity-Modulated Radiation Therapy
2009
Completed Phase 3
~1210
Methoxyamine
Not yet FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Eastern Cooperative Oncology Group (ECOG) performance status is a measure of how well a person is doing show original
The life expectancy of a patient is more than 12 months. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether 3-Dimensional Conformal Radiation Therapy will improve 2 primary outcomes and 4 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of 21 days.

Maximum tolerated dose (MTD) of methoxyamine in combination with pemetrexed disodium, cisplatin, and radiation therapy
21 DAYS
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. MTD is defined as the highest dose level in which 0/6 or 1/6 patients suffer dose-limiting toxicity.
Change in lab correlative expression levels (including UNG, TS, ERCC1, Ki-67 and TopoII-alpha)
BASELINE TO UP TO 6 MONTHS
The change of lab correlatives measured at baseline and post-treatment will be compared by paired T-test for interval scale measure and McNemar test for nominal measure.
Disease-free survival
UP TO 6 MONTHS
Disease-free survival is analyzed using the Kaplan-Meier method. Factors, such as age, gender, baseline histology and lab correlates including UNG, TS, ERCC1, Ki-67 and TopoII-alpha that predict survival will be identified by Cox model or extended Cox model.
Incidence of toxicity of the combination therapy
UP TO 6 MONTHS
Will be graded according to NCI CTCAE version 5.0. Toxicity data will be tabulated.
Response rate (clinical/tumor response)
UP TO 6 MONTHS
The true response rate of the combination therapy for this patient population will be estimated based on the number of responses using a binomial distribution and its confidence intervals will be estimated using Wilson's method. The factors that predict the response will be identified by logistic regression.
Progression-free survival (PFS)
AT 6 MONTHS
PFS is analyzed using the Kaplan-Meier method. Factors, such as age, gender, baseline histology and lab correlates including uracil deoxyribonucleic acid (DNA) N-glycosylase (UNG), thymidylate synthase (TS), excision repair cross-complementation group 1 (ERCC1), Ki-67 and Topoisomerase II-alpha (TopoII-alpha) that predict survival will be identified by Cox model or extended Cox model.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can carcinoma be cured?

Cancers can be stopped without remission in nearly 70% of patients. Therefore, this trial may provide some encouragement for people to seek early detection and treatment of cancer. Those tumors in which remission occurs frequently are: a) superficial tumor (tumor on the skin - non-melanoma) - most superficial tumors (tumors ≤2 cm); b) superficial tumor (tumor >2 cm) - non-aggressive (low grade non-melanoma), non-aggressive (medium grade non-melanoma); c) deep nodal tumor (tumors in major lymph nodes) - non-aggressive tumors (low grade non-melanoma).

Anonymous Patient Answer

How many people get carcinoma a year in the United States?

Approximately 2,100 people in the United States are diagnosed with carcinoma each year. The average age at diagnosis was 61.7 years, but this number varied by diagnostic site. Breast carcinoma and prostate carcinoma are disproportionately diagnosed in women younger than 40 years of age. These statistics were not similar for men and women.

Anonymous Patient Answer

What are the signs of carcinoma?

The signs of carcinoma include a history of oral cancer, skin cancer, or gynaecologic carcinoma, and signs of primary cancer such as weight loss, abdominal distention or, enlargement of lymph nodes. Other signs of secondary carcinoma includes a history of head and neck cancer, liver disease, or colorectal cancer. Many patients will present to secondary units prior to referral.

Anonymous Patient Answer

What are common treatments for carcinoma?

Chemoradiation may eradicate cancer but is not universally effective. Radical debulking surgery will often not be feasible due to disease spread in the abdomno pelvis. Chemotherapy may reduce tumour burden and improve outcomes for a certain period but is not a definitive option. Survival for metastatic disease is poor once it develops. As the only definitive treatment, radiotherapy has a role to play in the treatment of carcinoma. Radiotherapy is often used in conjunction with surgery, chemotherapy and/or chemoradiation. Lifestyle measures can be taken to reduce the risk of developing cancer later.

Anonymous Patient Answer

What causes carcinoma?

It is now evident that a number of factors trigger or increase the risk of developing carcinoma, either by direct action of the factors or by promoting carcinogenic processes or by facilitating the development of pre-existing cancer. It has been shown that cigarette smoking raises the risk of developing lung cancer, but the other main risk factors also vary by race and gender. Among women who have never smoked, estrogen can also be implicated in carcinogenesis, while overweight/obesity is thought to be the factor most strongly associated with the development of breast cancer.

Anonymous Patient Answer

What is carcinoma?

Carcinoma is a neoplasm in the form of cancer, which includes skin, colon, stomach, liver, lung, ovarian and bladder cancer, but not hematopoietic, leukemias, or lymphomas.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma?

While most patients with carcinoma are not candidates for clinical trials, they can benefit from these trials by increasing their quality of life, and helping them choose the most appropriate treatment. Therefore, clinical trials are an option for all patients who choose non-surgical or palliative treatments. Patients should always discuss with their oncologists if the experimental drug could help them live longer.

Anonymous Patient Answer

What are the chances of developing carcinoma?

Although carcinoma rates of the cervix and of the vagina do not significantly differ to those in the general population, the lifetime risk of developing any vulvar or vaginal cancer (0.36 and 0.34 per 1000 person-years, respectively) is more than double that of developing any cervix carcinoma (0.14 per 1000 person-years). These risks are similar for the two most prevalent vulvar and vaginal cancers.

Anonymous Patient Answer

What are the common side effects of 3-dimensional conformal radiation therapy?

Most side effects were mild, although five of the 17 side effects resulted in permanent changes or were permanent grade 3 changes in the CTCS. The side effects most frequently identified in this study included fatigue, vomiting, and diarrhea.

Anonymous Patient Answer

Does carcinoma run in families?

Data from a recent study suggests that, in addition to the familial aggregation of many cancers, the familial aggregation of non-melanoma skin malignancies is significant. Thus, non-melanoma skin cancers may be an important part of the genetic spectrum of this most common cancer.

Anonymous Patient Answer

What does 3-dimensional conformal radiation therapy usually treat?

We conclude that the conformal radiation therapy regimen used in this study will hopefully lead to significant improvements in the local control of localized and regional disease compared with the traditional 2D technique.

Anonymous Patient Answer
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