Clinical trial: Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas (NCT00881595)

Eligibility criteria:
Inclusion Criteria:

          -  Patients must have histologic and radiographic proof of localized high-risk soft
             tissue sarcoma (STS) required prior to registration.

          -  For the purpose of this study, high risk STS is defined by at least two of the
             following risk factors:

               -  Tumor ≥ 5 cm in maximal diameter on MRI or CT

               -  Histology grade 3 or 4 (AJCC, 7th edition)

               -  Tumor deep to the investing fascia

               -  Locally recurrent sarcoma with no prior radiation therapy to the primary site

               -  Age >55 years old

          -  Tumor must be considered potentially resectable as defined by cross sectional imaging.

          -  At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
             Patients must have ≤ grade 1 acute toxicities of any prior treatment with anti-cancer
             modalities (returned to baseline status as noted before most recent treatment).
             Patients with persisting, stable chronic toxicities from prior treatment ≤ grade 1 are
             eligible.

          -  Age ≥18 years at time of consent.

          -  Physician documented life expectancy of greater than 3 months.

          -  Patients must have normal organ and marrow function within 4 weeks prior to study
             treatment as defined below:

               -  hemoglobin ≥ 9 g/dL

               -  leukocytes ≥3,000/microliter (mcL)

               -  absolute neutrophil count ≥1,500/mcL

               -  platelets ≥100,000/mcL

               -  total bilirubin ≤ institutional upper limit of normal

               -  aspartate aminotransferase (AST/SGOT) and alanine aminotransferase(ALT/SGPT) <
                  2.5 x institutional upper limit of normal

               -  creatinine within 1.5 x upper limit of normal(ULN)

          -  Women of child-bearing potential 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 and for 12 months after treatment. Patients must have a
             negative serum pregnancy test within 14 days prior to beginning treatment on this
             trial. Sexually active men must also use appropriate contraception method and should
             not father a child while receiving therapy during this study.

          -  Ability to understand and the willingness to sign a written Institutional Review
             Board(IRB) stamped, study specific informed consent document prior to any research
             related procedures or study treatment.

        Exclusion Criteria:

          -  Receiving any investigational agents.

          -  Treatment with cytotoxic agents and/or treatment with biologic agents within the 4
             weeks prior to beginning treatment on this study.

          -  Evidence of metastatic disease.

          -  Previous radiotherapy to the affected site.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris,
             uncontrolled cardiac arrhythmia, and/or psychiatric illness/social situations that
             would limit compliance with study requirements.

          -  Pregnant women are excluded from this study because the investigational agents may
             have the potential for teratogenic or abortifacient effects. Because there is an
             unknown but potential risk for adverse events in nursing infants secondary to
             treatment of the mother with these agents, breastfeeding should be discontinued if the
             mother is treated.

          -  HIV-positive patients are ineligible because these patients are at increased risk of
             lethal infections when treated with marrow-suppressive therapy and the potential
             pharmacokinetic interaction between antiretroviral therapy and the investigational
             agents.

          -  All herbal and/or alternative medications should be discontinued while on study, these
             include but are not limited to: Hydrastis canadensis (goldenseal), Uncaria tomentosa
             (cat's claw) or Echinacea angustifolia.

          -  Requirement for treatment with immunosuppressive agents or chronic steroids.

          -  A history of a hypersensitivity reaction to any of temozolomide's components or to
             Dacarbazine(DTIC).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment