Treatment for Digestive System Neoplasms

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Texas MD Anderson Cancer Center, Houston, TX
Digestive System Neoplasms+3 More
Eligibility
18+
All Sexes
Eligible conditions
Digestive System Neoplasms

Study Summary

This study is evaluating whether chemotherapy may help treat appendiceal cancer.

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Eligible Conditions

  • Digestive System Neoplasms
  • Adenocarcinoma
  • Gastrointestinal Neoplasms
  • Pseudomyxoma Peritonei

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Digestive System Neoplasms. Measurement will happen over the course of 6 months.

6 months
Tumor Growth Rate

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Chemotherapy Group

This trial requires 30 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment 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.

Chemotherapy Group
Behavioral
Patients receive chemotherapy for 6 months, then observed for 6 months. The exact type of fluoropyrimidine-based chemotherapy is not mandated and final treatment decisions will be left to the medical oncologist who is administering the chemotherapy. All chemotherapy adjustments will be done by the treating medical oncologist according to standard of care.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

University of Texas MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histological evidence of a metastatic well differentiated or moderately differentiated mucinous appendiceal epithelial neoplasm (AEN).
Radiographic images demonstrating the presence of mucinous peritoneal carcinomatosis (PMP).
Patients must not be considered a candidate for a complete surgical cytoreductive surgery. This determination will be made through either discussion at MD Anderson peritoneal surface malignancy multidisciplinary review or consultation with MD Anderson peritoneal surgeon.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Age >/= 18 years old.
Patients must be able to understand and provide answers to the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/OV-28 QOL questionnaires in order to participate in the trial.
Women must not be pregnant or lactating. Women of childbearing potential must have a negative Beta-HCG serum pregnancy test and agree to refrain from breast-feeding, as specified in the informed consent given the unknown risk of teratogenicity of agents in the study. Patients of childbearing potential agree to use an effective form of contraception during chemotherapy and for 90 days following the last chemotherapy treatment.
Patients must agree to participate and be able to understand and provide informed consent to participate in the trial.
Adequate bone marrow function as evidenced by: Hemoglobin >/= 9.0 g/dl; Platelet >/= 75,000 cells/mm^3; Absolute neutrophil count >/= 1000/mm^3.

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 digestive system neoplasms be cured?

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T2T3 T4 and metastatic neoplasms have a poor prognosis. Some patients do not respond to treatment; surgical resection should be considered for patients with a life expectancy above 3-4 years.

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What are the latest developments in treatment for therapeutic use?

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Despite increasing acceptance of neoadjuvant chemotherapy as a standard treatment for oesophageal cancer, there are increasing indications that it is most effective in early disease.

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What is digestive system neoplasms?

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Digestive system neoplasms are a very large and diverse group of neoplasms in which most have a poor prognosis or no treatment available. The most common types of digestive system neoplasms are carcinoma in situ and squamocarcinoma. We can summarize the common features of neoplasms of the gastrointestinal system. Digestive system cancers have very diverse natural history and they are usually not curable. Digestive tract neoplasms are frequently a reflection of normal variations of embryogenesis of these tissues and are most often due to infection of origin or neoplasia in the normal structure.

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What causes digestive system neoplasms?

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Different kinds of digestive system cancer are very differently related with their causes. Most of the other types of cancers in the digestive system are not very precisely related to their precise causes. The causes of some digestive tract cancers and other benign tumor syndromes are related. In most cases, we might not be able to determine the precise causes of the development of malignant neoplasms and some benign tumors. The causes of digestive system cancers cannot be determined on the basis of their specific causes. For most of them, we need to investigate their causes in an integrated manner based on the general causes of cancer, particularly based on the specific causes of other kinds of cancers in the same region.

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What are the signs of digestive system neoplasms?

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Dyspepsia, weight loss and anemia denote digestive tract malignancy. Malignant tumors of the digestive system have a characteristic CT and ultrasound picture. CT is the best and only modality for diagnosis in a majority of cases. CT plays a part in staging and assessing the extent of the tumor, the possible involvement of adjacent organs and the prognosis.

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How many people get digestive system neoplasms a year in the United States?

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Gastrointestinal neoplasms accounted for 3.4% of all cancer-related deaths and 13% of cancer-related deaths among males. These data highlight the continuing challenge in designing and conducting studies to identify appropriate gastrointestinal oncologic surveillance strategies for patients with these often hard-to-detect neoplasms.

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What are common treatments for digestive system neoplasms?

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There are many different treatments for digestive system cancers. Most commonly, patients receive multiple treatment strategies that include surgery, chemotherapy, and palliative therapy; some patients receive treatments to reduce risk of complications or regain mobility due to digestive system diseases. The decision regarding treatment options for patients with gastrointestinal cancer is complicated by comorbidities and the unique characteristics of the disease process in question. Gastrointestinal specialists are highly sought after for the management of patients with digestive system disease.

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Is treatment typically used in combination with any other treatments?

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Treatment usually combined with other treatments is used rarely. The most common use of treatment combination is in combination with surgery. The other treatments have their own use in about 5% of patients. The use of treatment combination does not appear affected by any of the patient characteristics.

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How quickly does digestive system neoplasms spread?

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The majority of new cases of gastric non-Hodgkin lymphoma and of oesophageal non-Hodgkin lymphoma were detected during a period when patients survived longer. Recent findings showed that digestive system neoplasms are a distinct disease from other malignancies, and the survival of patients is shorter. When new cases of digestive system neoplasms are diagnosed, we should make an effort to find them in time so that treatment is as early as possible. For this, we should develop effective techniques in diagnosis and treatment of oesophageal lymphoma and non-Hodgkin lymphoma, and we encourage multi-centres to set up registries of patients.

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Does treatment improve quality of life for those with digestive system neoplasms?

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For patients with gastrointestinal neoplasms, routine QOL measures improve our ability to identify patients most likely to have poor outcomes and who may benefit from a specific type of treatment.

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What is treatment?

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There are various approaches in the treatment of esophageal cancer in our clinic. The most common is esophagectomy with an additional adjuvant chemotherapy or radiotherapy. However, for certain patients with esophageal cancer, we will often perform chemotherapy alone first, because then, if there is improvement we will combine chemoradiotherapy afterward. There is a high risk of relapse even if the initial chemotherapy is efficacious. In patients who can return to the [home with] their spouse or family for daily care, we will use a daily stoma.

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Is treatment safe for people?

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The risk of a person needing surgery after endoscopic intervention, and also the rate of postoperative complications, were higher in our cohort of patients with a diagnosis of carcinoid tumor compared with a diagnosis of a benign lesion. Patients with a diagnosis of carcinoid tumor were more likely to need a pancreaticoduodenectomy in combination with endoscopic treatment.

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