Back to resultsA Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
Primary Purpose
Rectal Cancer, Radiotherapy
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Short-course radiotherapy
FOLFOX4 chemotherapy,preoperative
Radiotherapy of neo-adjuvant therapy
Concurrent chemotherapy of neo-adjuvant therapy
Radical rectal cancer resection
FOLFOX4 chemotherapy,post-operative
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer, Radiotherapy focused on measuring rectal cancer, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- 1. Consent to this study
- 2. Histological or cytological confirmed diagnostic of rectal carcinoma
- 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)
- 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
- 5.With no presence of other organ metastasis or extra-regional lymph node involvement
- 6.With no history of chemotherapy
- 7.ECOG score is 0 or 1
- 8.Adequate ability of bone marrow, liver and kidney function
- 9.No pregnancy
Exclusion Criteria:
- Unable to intake oral medicine
- Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe
- HIV infection or Active chronic HBV or HCV
- Severe clinical infection at active stage
- Epileptic seizure need treatment
- History of organ transplantation
- Renal failure or intaking renal dialysis
- Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics
- Severe unhealed wound or skin ulcer or bone fraction
- Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years
12.Chronic inflammatory bowel disease， bowel obstruction，hereditary fructose intolerance 13.Medicine abuse；medical，psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Preoperative chemotherapy with short-course radiotherapy
Preoperative neo-adjuvant therapy
Arm Description
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
Preoperative treatment:neo-adjuvant therapy
Outcomes
Primary Outcome Measures
Pathological Response
Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer)
Secondary Outcome Measures
3-year Disease-Free Survival
time from radical resection to recurrence or end of follow-up
3-year Overall Survival
time from radical resection to cancer caused death or end of follow-up
Full Information
NCT ID
NCT02941562
First Posted
October 20, 2016
Last Updated
October 21, 2016
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02941562
Brief Title
A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
5. Study Description
Brief Summary
The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome
Detailed Description
This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Radiotherapy
Keywords
rectal cancer, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative chemotherapy with short-course radiotherapy
Arm Type
Experimental
Arm Description
Preoperative treatment:4 course of FOLFOX4 therapy combined with short-course radiotherapy
Arm Title
Preoperative neo-adjuvant therapy
Arm Type
Active Comparator
Arm Description
Preoperative treatment:neo-adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
Short-course radiotherapy
Intervention Description
Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis
Intervention Type
Drug
Intervention Name(s)
FOLFOX4 chemotherapy,preoperative
Intervention Description
FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.
Repeat every 2 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy of neo-adjuvant therapy
Intervention Description
Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis
Intervention Type
Drug
Intervention Name(s)
Concurrent chemotherapy of neo-adjuvant therapy
Intervention Description
Capecitabine 825mg/m2 twice daily 5 days/week
Intervention Type
Procedure
Intervention Name(s)
Radical rectal cancer resection
Intervention Description
Radical rectal cancer resection
Intervention Type
Drug
Intervention Name(s)
FOLFOX4 chemotherapy,post-operative
Intervention Description
FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.
Repeat every 2 weeks
Primary Outcome Measure Information:
Title
Pathological Response
Description
Treatment effects of interventions. The tumor response should be graded on a scale of 0 (complete response- no viable cancer cells observed) to 3 (poor response - minimal or no tumor kill; extensive residual cancer)
Time Frame
Surgery
Secondary Outcome Measure Information:
Title
3-year Disease-Free Survival
Description
time from radical resection to recurrence or end of follow-up
Time Frame
3 years
Title
3-year Overall Survival
Description
time from radical resection to cancer caused death or end of follow-up
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Consent to this study
2. Histological or cytological confirmed diagnostic of rectal carcinoma
3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)
4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
5.With no presence of other organ metastasis or extra-regional lymph node involvement
6.With no history of chemotherapy
7.ECOG score is 0 or 1
8.Adequate ability of bone marrow, liver and kidney function
9.No pregnancy
Exclusion Criteria:
Unable to intake oral medicine
Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe
HIV infection or Active chronic HBV or HCV
Severe clinical infection at active stage
Epileptic seizure need treatment
History of organ transplantation
Renal failure or intaking renal dialysis
Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics
Severe unhealed wound or skin ulcer or bone fraction
Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years
12.Chronic inflammatory bowel disease， bowel obstruction，hereditary fructose intolerance 13.Medicine abuse；medical，psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Cui, MD.PhD.
Phone
+86-25077850
Email
longcuidr@126.com
12. IPD Sharing Statement
Learn more about this trial
A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT
We'll reach out to this number within 24 hrs