Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer
NCT ID: NCT01584544
Last Updated: 2015-04-20
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-01-31
Study Completion Date
2014-05-31
Brief Summary
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This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.
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Detailed Description
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It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility.
Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.
The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.
Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.
The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.
Conditions
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Rectal Neoplasms
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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1000mg
capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.
Group Type
EXPERIMENTAL
capecitabine
Intervention Type
DRUG
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
1200mg
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Group Type
EXPERIMENTAL
Capecitabine
Intervention Type
DRUG
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
1350mg
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Group Type
EXPERIMENTAL
Capecitabine
Intervention Type
DRUG
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
1500mg
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Group Type
EXPERIMENTAL
Capecitabine
Intervention Type
DRUG
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
1650mg
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Group Type
EXPERIMENTAL
Capecitabine
Intervention Type
DRUG
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Interventions
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capecitabine
oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Intervention Type
DRUG
Capecitabine
oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Intervention Type
DRUG
Capecitabine
oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Intervention Type
DRUG
Capecitabine
oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Intervention Type
DRUG
Capecitabine
oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
Intervention Type
DRUG
Other Intervention Names
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stare 1
stare 2
stare 3
stare 4
stare 5
Eligibility Criteria
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Inclusion Criteria
* rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
* KPS status no less than 70; Charlson comorbidity no more than 3.
* life expectancy more than 6 months.
* hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
* do not have allergy history to thymidine phosphorylase.
* do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
* no previously pelvic irradiation history
* informed consent signed
* KPS status no less than 70; Charlson comorbidity no more than 3.
* life expectancy more than 6 months.
* hemoglobin \>= 100g/L, white blood cell \>= 3.5\*10E9/L, neutrophil \>= 1.5\*10E9/L, platelet \>= 100\*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
* do not have allergy history to thymidine phosphorylase.
* do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
* no previously pelvic irradiation history
* informed consent signed
Exclusion Criteria
* other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
* previous pelvic irradiation history
* receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
* allergy history to thymidine phosphorylase
* active infection existed
* severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
* anticipate other clinical trials in four weeks before enrollment
* previous pelvic irradiation history
* receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
* allergy history to thymidine phosphorylase
* active infection existed
* severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
* anticipate other clinical trials in four weeks before enrollment
Minimum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Jing Jin, M.D.
vice chair of radiation department
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jing Jin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academic Medical Science
Yexiong Li, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academic Medical Science
Locations
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radiation department, Cancer Hospital, CAMS
Beijing, Beijing Municipality, China
Site Status
Countries
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China
References
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Other Identifiers
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CH-GI-024
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer
NCT04833387
ACTIVE_NOT_RECRUITING
PHASE2
Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal Cancer
NCT00084591
COMPLETED
PHASE1
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
NCT06056804
ACTIVE_NOT_RECRUITING
PHASE2
Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer
NCT06493240
COMPLETED
PHASE2
Total Neoadjuvant Induction and Consolidation CapeOX Plus IMRT With Capecitabine for MRI Defined High-risk Rectal Cancer
NCT02864849
COMPLETED
PHASE2
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
NCT06024356
UNKNOWN
Irinotecan Liposome Plus Capecitabine and Enronsubemab Combined With Short-course Radiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
NCT07281157
RECRUITING
PHASE2
High Dose Radiotherapy for the Treatment of Rectal Cancer
NCT03541304
COMPLETED
Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
NCT01671683
COMPLETED
Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC
NCT03156036
COMPLETED
PHASE2
A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
NCT00122291
UNKNOWN
PHASE2
Multi-omics Model Predicts Efficacy of Preoperative Neoadjuvant Chemoradiotherapy Combined PD-1 Antibody Therapy for Locally Advanced Rectal Cancer
NCT05368051
UNKNOWN
Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer
NCT02195141
UNKNOWN
PHASE2
Involve-site Radiotherapy Combined With Chemotherapy and Immunotherapy as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
NCT07161115
NOT_YET_RECRUITING
PHASE2
Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
NCT06300489
RECRUITING
PHASE1
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
NCT06017583
RECRUITING
PHASE3
Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer
NCT03381352
UNKNOWN
PHASE2
TIME in Immunotherapy Combined With nCRT for Rectal Cancer
NCT05507112
NOT_YET_RECRUITING
PHASE2
Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer
NCT00714077
UNKNOWN
Tailored Operative or Non-operative Management for Low-risk Rectal Cancer After Intensive Neoadjuvant Treatment
NCT02860234
COMPLETED
Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
NCT04558684
SUSPENDED
PHASE1/PHASE2
A Trial of High Intensity Versus Low Intensity Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer
NCT01064999
UNKNOWN
PHASE2/PHASE3