Gastric Cancer Clinical Trial
— IMRTOfficial title:
Phase II Clinical Trial: The Effect of Bone Marrow-sparing Intensity-Modulated Radiotherapy (BMS-IMRT) on Reduction Acute Hematologic Toxicity in Gastric and Rectal Cancer Patients Treated With Concurrent Chemotherapy and IMRT
Concurrent chemotherapy with external beam radiotherapy is the standard treatment of bulky or
locally advanced cervical cancer, gastric cancer and rectal cancer.Despite excellent
therapeutic results, acute hematologic toxicity (HT) is common with this regimen. Previous
studies have founded acute HT was significantly associated the volume of pelvic (PBM) and
lumbosacral bone marrow (LSBM) receiving 10 and 20 Gy radiation (RT). Therefore, reducing the
volume of BM receiving low-dose RT might prevent HT.
More than one-half of the body's bone marrow (BM) is located in the PBM, LSBM and proximal,
where is just in the low dose of RT in patients with gastric, rectal and cervical cancer.
Previous study have demonstrated highly conformal IMRT treatment plans reduced the volume of
PBM irradiated resulting in less HT. We have since assumed that even better BM sparing is
possible when the BM is entered as a separate constraint in the planning process. However, it
is well known that hematopoietically active (red) BM is poorly visualized with computed
tomography (CT). Consequently, the entire contents of the medullary canals must be entered as
BM. Yet, a considerable portion of the medullary canal is comprised of inactive (yellow)
marrow, which is composed primarily of fat. Contouring the entire medullary canals on CT thus
overestimates the volume of active BM, unnecessarily constraining the IMRT plan. An
alternative approach is the incorporation of functional BM imaging into the treatment
planning process. One economical and efficiency approach involves the use of T1-weighted
magnetic resonance (MR) images.
Therefore, we designed this study to test whether a separate constraint of active BM
identified by MR could reduce acute HT in course of concurrent chemoradiotherapy for patients
with gastric and rectal cancer.
Status | Unknown status |
Enrollment | 58 |
Est. completion date | October 2015 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: All gastric cancer patients had to fulfill the following criteria: histologically confirmed adenocarcinoma of the stomach, cancer resected without residual disease (R0 gastrectomy), at least a D1 lymph node dissection, a classification as stage II through III according to the 2009 staging criteria of the American Joint Commission on Cancer, at least 4 cycles of chemotherapy, age greater than 18 years and less than or equal to 75 years, a performance status of 1 or lower according to Eastern Cooperative Oncology Group (ECOG) criteria, adequate function of major organs (including cardiac, hepatic, and renal functions), adequate bone marrow function (hemoglobin>10g/dL; absolute neutrophil count [ANC]=2,000/µL; platelet count=100,000/µL; leukocyte count =4,000/µL), a caloric intake greater than 1,500 kcal/day by oral route, treatment beginning no later than 4 weeks after the last cycles of chemotherapy (but a delay of 1 week was allowed to permit full recovery, with restoration of adequate nutritional intake). All rectal cancer patients with histologically confirmed rectal adenocarcinoma that involved the distal 12 cm of the rectum without evidence of distant metastases were eligible. The patients had to have undergone a staging evaluation within 6 weeks before initiation of the study by endoscopic ultrasonography (US), with evidence of Stage T3 or T4 tumor and/or evidence of lymph node involvement defined by the presence of at least one enlarged perirectal lymph node >8 mm in size and sonographically suspicious for metastasis. No previous RT to the pelvis and no previous chemotherapy for rectal cancer were allowed. Other inclusion criteria are age greater than 18 years and less than or equal to 75 years, a performance status of 1 or lower according to Eastern Cooperative Oncology Group (ECOG) criteria, adequate function of major organs (including cardiac, hepatic, and renal functions), adequate bone marrow function (hemoglobin>10g/dL; absolute neutrophil count [ANC]=2,000/µL; platelet count=100,000/µL; leukocyte count =4,000/µL), a caloric intake greater than 1,500 kcal/day by oral route. Exclusion Criteria: For gastric patients, cases with stage IA or IB (T2aN0) disease (according to the American Joint Committee on Cancer 2002 staging system), microscopically positive resection margin, and involvement of M1 lymph node or distant metastases were excluded from the study; prior abdominal irradiation; For rectal patients, cases were excluded from the study if they had metastatic rectal cancer, other tumour types than adenocarcinoma of the rectum; prior pelvic irradiation; Other key exclusion criteria were: past or concurrent history of neoplasm except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix; current uncontrolled infection; unresolved bowel obstruction or subobstruction; uncontrolled Crohn's disease or ulcerative colitis; current history of chronic diarrhoea; other serious illness or medical conditions; contraindication towards study drugs and radiation; prior radiotherapy, chemotherapy or any targeting therapy; administration of any other experimental drug under investigation concomitantly or within 4 weeks before eligibility; and pregnant or lactating patients. |
Country | Name | City | State |
---|---|---|---|
China | Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hematologic toxicity | According to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria, primary endpoints of interest were the white blood cell count (WBC), absolute neutrophil count (ANC), hemoglobin (Hgb), and platelet count nadirs and highest grade of each toxicity occurring within 60 days of initiation of concurrent chemoradiotherapy (CRT). For rectal patients, Grade 2-4 leukopenia, neutropenia,anemia, and thrombocytopenia are considered as endpoints. For gastric patients, Grade 3-4 leukopenia, neutropenia,anemia, and thrombocytopenia are considered as endpoints. |
Within 60 days of initiation of concurrent chemoradiotherapy | |
Secondary | Low dose volume | the volume of active BM receiving 5,10,20,30 and 40 Gy | Within the course of concurrent chemoradiotherapy | |
Secondary | Conformity and Homogeneity of IMRT plan | Conformity Index (CI)and Homogeneity Index (HI) were used to evaluate the conformity and homogeneity of IMRT plan. | Within course of concurrent chemoradiotherapy |
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