Clinical Trials Logo

Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01863420
Other study ID # LC2012B22
Secondary ID
Status Unknown status
Phase Phase 2
First received May 26, 2013
Last updated May 28, 2013
Start date November 2012
Est. completion date October 2015

Study information

Verified date May 2013
Source Chinese Academy of Medical Sciences
Contact Jing Jin, MD
Phone +86-13601365130
Email jingjin1025@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

1、Simulation All patients underwent computed tomography (CT) simulation in the supine position for gastric cancer patients and The CT scan was obtained from the T4 vertebral body to L5 cm. Oral contrast and intravenous contrast were administered prior to the CT scan.

All patients underwent computed tomography (CT) simulation in the prone position for rectal cancer patients with a full bladder and using a belly board to minimize exposure of the small bowel. Oral contrast and intravenous contrast were administered prior to the CT scan. A radio-opaque marker was placed at the anal margin. The superior and inferior limits of the acquired transaxial data (set by the topogram) were the iliac crests and 5 cm inferior to the anal marker, respectively. Intravenous contrast were administered prior to the CT scan.

2.Radiotherapy and chemotherapy For gastric cancer patients after surgery and chemotherapy,the 4500 cGy of radiation was delivered in 25 fractions, five days per week, to the tumor bed, to the regional nodes, and 2 cm beyond the proximal and distal margins of resection. The tumor bed was defined by preoperative computed tomographic (CT) imaging, barium roentgenography, and in some instances, surgical clips. Perigastric, celiac, local paraaortic, splenic, hepatoduodenal or hepatic-portal, and pancreaticoduodenal lymph nodes were included in the radiation fields. In patients with tumors of the gastroesophageal junction, paracardial and paraesophageal lymph nodes were included in the radiation fields. Concurrent chemotherapy regimen is monotherapy with capecitabine 1600mg∙m2 twice a day (b.i.d.).

For rectal cancer patients before surgery, The rectum was not opacified with barium in order to avoid contour artifacts. The gross tumor volume (GTV) was generated with the CT scan, MR scan and endoscopic ultrasonography results. Only a clinical target volume (CTV) was delineated, encompassing the entire mesorectum, Pararectal nodes were also included, together with the presacral and promontory nodes (limit to L5-S1 interspace ), and the internal iliac nodes up to the venous bifurcation. External iliac nodes were not included as they have not been a site for recurrence in our experience. On the contrary, internal pudendal nodes were included in the CTV. Organs at risk were also contoured: bladder (with intravenous contrast), small bowel (with oral contrast) and femoral heads. The small bowel was contoured on all CT slices where it could be visualized, which was highly variable among patients. IMRT is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.

3. Active bone marrow definition All the patient was scanned in the supine position on a 1.5 T MR scanner. For gastric cancer patients, the images were obtained from the T8 to L4 for gastric cancer patients. For rectal cancer patients, the images were obtained from the L3-4 interspace to below the ischial tuberosities for rectal cancer patients.

The MR images were subsequently fused with the planning CT scan using commercially available image fusion software. The interactive mode of the fusion software was used whereby the user manually translates and rotates the MR scan to produce the best visual overlay of the two image sets. A mutual information algorithm was then used to perform a fine adjustment. The CT and MR images (resliced along the planes of the CT scan) were subsequently displayed side-by-side. BM regions on the T1-weighted images that showed a signal intensity equal to or slightly higher than that of muscle were contoured as active BM. The range of active BM was 3cm beyond the upper limit of PTV and 3cm below the lower limit of PTV.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Bone Marrow-sparing Intensity-Modulated Radiotherapy
Use Bone Marrow-sparing Intensity-Modulated Radiotherapy to limit the dose of active bone marrow in radiation fields. The BM regions on the T1-weighted images that showed a signal intensity equal to or slightly higher than that of muscle were contoured as active BM

Locations

Country Name City State
China Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2