A Phase III Randomized Controlled Study of Neoadjuvant FOLFOX6 Treatment With or Without Radiation Compared to 5-Fu Based Chemoradiation in Treating Patients With Resectable Rectal Cancer
18 Years
75 Years
Both
Rectal Cancer
Trial Information
A Phase III Randomized Controlled Study of Neoadjuvant FOLFOX6 Treatment With or Without Radiation Compared to 5-Fu Based Chemoradiation in Treating Patients With Resectable Rectal Cancer
OBJECTIVES:
Primary Compare the objective response rate and the rate of local-regional relapse in
patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based
chemoradiotherapy or FOLFOX alone without radiation.
Secondary
1. Compare the rate of pathologic complete response in patients treated with these
regimens.
2. Determine the increase in the number of patients who are able to undergo
sphincter-saving surgery after treatment with these regimens.
3. Correlate genetic patterns and the presence or absence of specific tissue biomarkers
with response and prognosis in patients treated with these regimens.
4. Compare preoperative quality of life (QOL) of patients treated with oral capecitabine
versus continuous infusion with fluorouracil. pelvic auto-nerve function
5. Determine the impact of oxaliplatin on neurotoxicity in patients treated with these
regimens.
6. Compare the toxic effects of these regimens in these patients.
7. Compare the convenience of care in patients treated with these regimens.
8. Determine the impact of the type of surgical management on QOL at 1 year
postoperatively in these patients.
OUTLINE: This is a randomized, multi-center study. Patients are stratified according to
participating center, gender, clinical tumor stage (stage II vs. stage III), and surgical
intent (sphincter saving vs. non-sphincter saving). Patients are randomized to 1 of 4
treatment arms.
- Arm A: Patients receive fluorouracil IV continuously and undergo radiotherapy once
daily 5 days a week for 5-6 weeks.
- Arm B: Patients receive FOLFOX for 4 cycles and undergo radiotherapy as in arm I from
the second cycle of FOLFOX.
- Arm C: Patients receive FOLFOX for 4 cycles Within 4-6 weeks after the completion of
chemo radiotherapy, patients with responding or stable disease undergo surgery.
Patients with progressive disease are treated at the discretion of the investigator and
continue to be followed. Patients with progressive disease in arm III should received
radiation.
Quality of life is assessed at baseline, at completion of chemo radiotherapy, and at 1 year
after surgery.
After completion of study treatment, patients are followed every 3 months for 2 years, and
then every 6 months for 3years.
PROJECTED ACCRUAL: A total of 495 patients will be accrued for this study within 5 years.
Eligibility Ages Eligible for Study: 18-75 Years old Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
1. Diagnosis of adenocarcinoma of the rectum
2. Age: 18-75 years old
3. Stage of the primary tumor may be determined by ultrasound or MRI
4. Stage II (T_3-4, N_0 [N_0 is defined as all imaged lymph nodes < 1.0 cm]) OR stage
III (T_1-4, N_1-2 [with the definition of a clinically positive lymph node being any
node ≥ 1.0 cm]
5. Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope
6. Distal border of the tumor must be located < 12 cm from the anal verge
7. Tumor amenable to curative resection
8. 15 days prior recruit, meet the following criteria: Hematopoietic
- Absolute neutrophil count ≥ 1,200/mm^3
- Platelet count ≥ 100,000/mm^3 Hepatic
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- AST ≤ 2 times ULN*
- No hepatic disease that would preclude study treatment or follow-up
- No uncontrolled coagulopathy Renal
- Creatinine clearance > 50 mL/min
- No renal disease that would preclude study treatment or follow-up
9. ECOG status: 0～1
Exclusion Criteria:
1. Hypersensitivity to fluorouracil, or oxaliplatin
2. No More than 4 weeks since prior participation in any investigational drug study
3. More than 4 weeks since prior participation in any investigational drug study
4. Clear indication of involvement of the pelvic side walls by imaging
5. With distant metastasis
6. History of invasive rectal malignancy, regardless of disease-free interval
7. Fertile patients must use effective contraception
8. Uncontrolled hypertension
9. Cardiovascular disease that would preclude study treatment or follow-up
10. Lack of upper gastrointestinal tract integrity or malabsorption syndrome，active upper
gastrointestinal tract bleeding
11. Synchronous colon cancer
12. Pregnant or nursing, Fertile patients do not use effective contraception
13. Other malignancy within the past 5 years except effectively treated squamous cell or
basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or
carcinoma in situ of the colon or rectum
14. No psychiatric or addictive disorders, or other conditions that, in the opinion of
the investigator, would preclude study participation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3-year disease free survival
Outcome Description:
Compare 3-year disease free survival in patients with resectable rectal cancer treated with either 5-Fu or FOLFOX based chemoradiotherapy or FOLFOX alone without radiation.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Jianping Wang, MD
Investigator Role:
Study Director
Investigator Affiliation:
Sun Yatsen University
Authority:
China: Food and Drug Administration
Study ID:
GIHSYSU01
NCT ID:
NCT01211210
Start Date:
June 2010
Completion Date:
June 2020
Related Keywords:
- Rectal Cancer
- rectal cancer
- neoadjuvant therapy
- oxaliplatin
- radiation
- Rectal Neoplasms
Name | Location |
|---|
