The Effect of Bone Marrow-sparing Intensity-Modulated Radiotherapy to GI Cancer

NCT01863420 | Unknown DMC

• 1 other identifier: LC2012B22
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Gastric Cancer; Bone Marrow Toxicity; Adverse Effect of Radiation Therapy

Keywords

gastric cancer; rectal cancer; bone marrow toxicity; IMRT; hematologic toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Low dose volume

  Within the course of concurrent chemoradiotherapy

• Conformity and Homogeneity of IMRT plan

  Within course of concurrent chemoradiotherapy

Study Arms (2)

Rectal cancer patients

For rectal cancer patients before surgery, 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.The dose constraints for active bone marrow are V5\<95%, V10\<88%,V20\<80%,V30\<65%, V40\<45%.

Radiation: Bone Marrow-sparing Intensity-Modulated Radiotherapy

Gastric cancer patients

For gastric cancer patients after surgery and chemotherapy,the 4500 cGy of radiation was delivered in 25 fractions, five days per week. Concurrent chemotherapy regimen is monotherapy with capecitabine 1600mg∙m2 twice a day (b.i.d.).The dose constraints for active bone marrow are V5\<90%, V10\<80%,V20\<70%,V30\<55%, V40\<35%.

Radiation: Bone Marrow-sparing Intensity-Modulated Radiotherapy

Interventions

Bone Marrow-sparing Intensity-Modulated Radiotherapy RADIATION

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

Gastric cancer patients; Rectal cancer patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

II/III rectal cancer and gastric cancer patients

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• Jianyang W, Yuan T, Yuan T, Xin W, Ning L, Hua R, Hui F, Yanru F, Shulian W, Yongwen S, Yueping L, Weihu W, Yexiong L, Jing J. A prospective phase II study of magnetic resonance imaging guided hematopoietical bone marrow-sparing intensity-modulated radiotherapy with concurrent chemotherapy for rectal cancer. Radiol Med. 2016 Apr;121(4):308-14. doi: 10.1007/s11547-015-0605-2. Epub 2015 Nov 27.

  PMID: 26612321 DERIVED

Biospecimen

Retention: NONE RETAINED

There is two study groups. Group A consists of 33 rectal cancer patients as designed. Group B consists of 25 gastric cancer patients as designed.

MeSH Terms

Conditions

Rectal Neoplasms; Stomach Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Wounds and Injuries

Study Officials

• Jing Jin, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

• Jianyang Wang, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  STUDY DIRECTOR

Central Study Contacts

Jing Jin, MD

CONTACT

+86-13601365130; jingjin1025@163.com

Jianyang Wang, MD

CONTACT

+86-13810095191; pkucell@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chairman in the department of Radiation Oncology

Study Record Dates

• First Submitted: May 26, 2013
• First Posted: May 29, 2013
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

CN (1)