Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Preoperative 5-Fu based chemoradiation has become standard treatment for stage 2/3 rectal cancer. However whether these patients, especially T3N0-1M0 patients, really need radiation for local control after total mesentery excision being applied in routine practice is still unknown. And whether new drugs adding in can achieve better local and distant control is worth investigating.

PURPOSE: This randomized phase II trial is studying 5Fu based radiation therapy or FOLFOX based radiation or FOLFOX alone, comparing them to see how well they work when given before surgery in treating patients with intermediate risk resectable rectal cancer. It is not yet known whether 5-Fu based or FOLFOX based radiation therapy or even FOLFOX alone is more effective in treating rectal cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Fluorouracil; Oxaliplatin

Criteria

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