CLINICAL TRIAL

Radiation therapy for Adenocarcinoma

Metastatic
Stage I
Recruiting · 18+ · All Sexes · Aurora, CO

This study is evaluating whether a short course of radiation therapy followed by chemotherapy may help treat rectal cancer.

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma of the Lower Rectum · Rectal Neoplasms · Adenocarcinoma

Treatment Groups

This trial involves 2 different treatments. 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 not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Radiation therapy
RADIATION
FOLFOX regimen
DRUG
Blood for ctDNA
PROCEDURE
Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) questionnaire
OTHER
Rectal biopsy samples
PROCEDURE
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
Radiation therapy
2013
Completed Phase 3
~2760
FOLFOX regimen
2009
Completed Phase 3
~2440

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:
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.
Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-2a, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI
Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy
Clinically detectable (MR, endoscopy, or DRE) tumor present
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
At least 18 years of age
Absolute neutrophil count (ANC) > 1,500 cells/mm3
Hemoglobin> 8 g/dl
Platelets >100,000 cells/mm3
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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: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
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 Radiation therapy will improve 1 primary outcome and 5 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Completion of treatment (estimated to be 22 weeks).

Clinical complete response rate
COMPLETION OF TREATMENT (ESTIMATED TO BE 22 WEEKS)
-Criteria for clinical complete response: No residual gross tumor at procto/sigmoidoscopy;, or only erythematous scar or ulcer No palpable tumor on DRE No radiographic evidence of tumor on MRI No suspicious mesorectal lymph nodes on MRI Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
COMPLETION OF TREATMENT (ESTIMATED TO BE 22 WEEKS)
Incidence of grade 3 or higher toxicity during treatment
COMPLETION OF TREATMENT (ESTIMATED TO BE 22 WEEKS)
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
COMPLETION OF TREATMENT (ESTIMATED TO BE 22 WEEKS)
Quality of anorectal function as measured by the FACT-C questionnaire
1 YEAR (BETWEEN 10-14 MONTHS POST TREATMENT START DATE)
Questionnaire with 5 sections (physical well-being, social/family well being, emotional well-being, functional well-being, and additional concerns) Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life the person has
1 YEAR (BETWEEN 10-14 MONTHS POST TREATMENT START DATE)
Incidence of post chemoradiotherapy grade 3 or higher toxicity
1 YEAR
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
1 YEAR
Organ preservation rate
2 YEARS
2 YEARS
Progression-free survival (PFS)
2 YEARS
Criteria for progressive disease *Increase in the size of primary tumor by RECIST criteria New metastatic disease
2 YEARS

Patient Q & A Section

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

What are common treatments for adenocarcinoma?

Common treatments include surgery, radiotherapy, chemotherapy, and radiation therapy. Surgical intervention is often followed by additional treatment, e.g., hormone therapy, lymph node irradiation, or CT. Chemotherapy is often used or complemented by hormonal therapy, radiotherapy, and surgery. Radiation therapy can be used alone or in addition to other treatments. Radiation therapy combined with surgery can delay local recurrence but is not generally indicated in lymph node-negative adenocarcinoma. The effects of CT in lung cancer are unclear. Radiotherapy in lung cancer is generally not recommended. Overall 5-year survival has not improved in the United States.

Anonymous Patient Answer

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

About 5.3 million new cases of adenocarcinoma are expected to be diagnosed in the US each year, making it the most common form of lung cancer. Adenocarcinoma typically occurs early among African Americans and men, and later among women.\n

Anonymous Patient Answer

What causes adenocarcinoma?

The pathogenesis of adenocarcinoma is not fully understood; for example, tumor viruses have been shown to influence the development of pancreatic cancer. Adenocarcinoma may be a multi-genic disorder where many genes are involved not only in genetic susceptibility but also in tumor formation. The pathogenesis also seems to be influenced by environmental factors of which the dietary intake is the main one.

Anonymous Patient Answer

Can adenocarcinoma be cured?

Adenocarcinoma should be staged by a combination of MRI, CT, PET, and endoscopic evaluation. Appropriate therapy can often be achieved in the setting of meticulous followup.

Anonymous Patient Answer

What are the signs of adenocarcinoma?

Most common signs of adenocarcinoma are a cough lasting>3 months, a fever with a rapid increase, erythema nodosum or lesions on the skin (e.g. swollen neck lymph nodes). Rarely, the disease involves the lung parenchyma and may therefore cause a dyspnoea which is a typical sign of adenocarcinoma.

Anonymous Patient Answer

What is adenocarcinoma?

Adenocarcinoma is the type of cancer most often to make up lung cancers. An adenocarcinoma is formed from cells made up primarily of glands that have grown together, and their interiors are covered with a thin layer of liquid, mucus, which, when the tumor is present, makes it readily identifiable when the tumor is grown. This is a cancer of the lungs, where the cells form a thin mucus covering (mucus is created by goblet cells). Adenocarcinoma is formed by the cells growing together and forming sheets which can eventually form a tumor. This cancer must also have spread to other areas of the lung, particularly the lymphatic system.

Anonymous Patient Answer

How quickly does adenocarcinoma spread?

The mean distance of local spread is about 13 mm, which is comparable with the reported mean distances of 12 and 18 mm of local spread of adenocarcinoma of the lung and the ocular adenocarcinoma. The prognosis of patients with early-stage disease does not seem to be poorer than that of patients with distant-spread disease.

Anonymous Patient Answer

What is the primary cause of adenocarcinoma?

In the absence of an obvious predisposing risk factor, the etiologic role of H pylori in adenocarcinoma of the colon remains elusive. This review demonstrates the necessity for large prospective, controlled, prospective cohort studies. Such studies will help to establish the association of H pylori with adenocarcinoma, and evaluate immunological response to H pylori.

Anonymous Patient Answer

What are the chances of developing adenocarcinoma?

The risk of developing adenocarcinoma after long-standing, benign polyps may depend in part on the individual genotypes of the genes coding for MLL2 and MSH2. The use of the Bethesda guidelines could refine the management of patients with a family history of adenocarcinoma, especially those with an MSH2 or MLL2 mutation.

Anonymous Patient Answer

Who should consider clinical trials for adenocarcinoma?

Age-adjusted cancer-specific mortality was higher for AA than whites in the AASMC cohort and was higher for AA when adjusted for socioeconomic status in the OSCCW cohort. This suggests that age-adjusted cancer-specific mortality may be a inappropriate outcome for clinical trials in AA.

Anonymous Patient Answer

What does radiation therapy usually treat?

This review describes the common areas and common effects of radiation therapy for cancers of the breast, salivary glands, prostate, colon, and lung. Understanding these effects will help people remember the signs and symptoms of breast cancer, oral cancer, and other maladies, and will support the clinician when counseling patients about radiation therapy. All radiation oncologists should be aware of the changes in normal tissues that occur after radiation therapy. It is essential that patients understand their likelihood of benefits and treatment-specific side effects.

Anonymous Patient Answer

Does adenocarcinoma run in families?

The families with HNPCC-associated carcinomas present a greater frequency of cases of siblings with endometrioid adenocarcinomas. This suggests that these two types of carcinoma may have common risk factors.

Anonymous Patient Answer
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