This trial is evaluating whether radiation therapy will improve 5 primary outcomes and 17 secondary outcomes in patients with Hodgkin Disease. Measurement will happen over the course of From enrollment to end of therapy (approximately 8 months).
This trial requires 77 total participants across 2 different 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 in Phase 2 and have already been tested with other people.
Most people presenting with generalized pain to the lymph nodes do not need to have an FNA. There may be other signs that need to be addressed, such as a palpable lymph node and associated signs of lymphadenopathy.
The cause(s) of Hodgkin disease are not fully understood even though advances in cancer research and treatment have drastically decreased the mortality rate of this disease. Factors that have been associated with an increased risk include smoking tobacco, being female, exposed to pesticides & radioactive substances, excessive alcohol intake, and immunologic abnormalities. Hodgkin disease causes the body to produce antibodies and it is these antibodies that are the basis of antibody-based immunotherapy treatment. The exact mechanism by which the body reacts to Hodgkin disease is unknown. However, the risk is greater in individuals who have certain genetic predispositions. One such genetic predisposition is a monomorphic (single-celled) chromosomal abnormality called mixed chimerism.
The majority of patients with untreated HD could be cured. The patients' overall response was similar in both studies. Treatment may have been more effective in the second study, possibly due to the more aggressive treatment of HD in this study, which might have resulted in fewer late effects. Clinical trials show that patients tend to benefit from aggressive treatment.
In spite of the fact that radiotherapy is the first choice treatment for Hodgkin Disease, it often fails to eradicate the disease. Chemotherapy and other chemotherapy-based therapies are used in case of complete remission after radiotherapy.
About 5,800 people will be diagnosed with HL in the United States this year. The overall five-year incidence for all forms of HL is about 1.44 per 100,000 person-years. The incidence by race, sex and age was: 0.46 for Caucasians, 0.77 for blacks, 1.01 for Hispanics and 2.24 for elderly men. The overall five-year mortality was 5.1%. The incidence and mortality were significantly higher for people 45 years of age and older. These estimates for HL are very similar to the estimates for non-Hodgkin lymphoma, because HLs and non-Hodgkin lymphomas are closely related.
Hodgkin disease is a type of lymphoma that typically manifests in men under the age of 30 and can cause various types of symptoms such as fever, night sweats, and pain in all joints and skin. It typically occurs in the nodal lymph nodes as lymph nodes filled with cancerous cells, but can appear in the bloodstream as a type of blood cancer where it is called a primary lymphocytosis.
Hodgkin disease is a cause of fatal acute lymphoblastic leukaemia and is considered to be a rare cause of non-Hodgkin lymphoma. The outcome of chronic lymphocytic leukaemia depends on the stage of Hodgkin disease; however acute lymphoblastic leukaemia occurring during the acute phase of Hodgkin disease has been associated with death. The prognosis is good in patients who are treated with high dose therapy and consolidation with autologous stem cell transplantation for all stages. In patients who are progressing on standard treatments, the chance of cure is extremely low. Hence, in the absence of curative drugs, the disease carries a poor prognosis.
Radiotherapy given during the earlier part of treatment was not related to any significant improvement in self-reported QOL or overall health among those treated with ATG, except for reductions in side effects. Patients treated with ATG reported fewer severe and more moderate dermatologic/ cutaneous adverse effects compared with those not treated with ATG.
Radiation chemotherapy and radiotherapy are commonly used therapies for Hodgkin disease. These therapies can be efficacious for patients with disease at stage I and II-III. This disease is typically cured without compromising functional outcome or delaying the eventual need for surgery. Radiation therapy for patients with advanced disease is not as effective nor as well tolerated as for patients with early disease.
This exploratory study suggests that siblings with Hodgkin disease may share a heightened risk for the disease and have more extensive involvement of the hematogenous tract in their disease, although the data suggest that the heightened risk is not genetic. Further investigations would be interesting to gain a better understanding of the mechanisms of disease development in sporadic vs nonfamilial cases.
Radiation therapy improves overall and freedom from progression OS and PFS compared with a placebo treatment. Treatment is also better than a standard systemic therapy or observation alone. Given these results, all patients with stage III Hodgkin's disease should be offered treatment with radiation. A combination with chemotherapy is effective, but the optimal combination remains to be established.
Radiation therapy has been evaluated in several clinical trials. However studies have varied significantly in terms of radiation dosage, number of treatments, duration of therapy and end points of interest. More studies exploring the best treatment of radiation for Hodgkin disease must be conducted.