Know Cancer

or
forgot password

A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum


N/A
18 Years
80 Years
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum


OBJECTIVES:

Primary

- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer
treated with either surgical resection or neoadjuvant.

Secondary

- Compare the side effect of chemo radiotherapy according to the Common Toxicity
Criteria(CTC) version 2.0 in patients treated with these regimens.

- Compare the postoperative complications in patients treated with these regimens.

- Compare the recurrent rate in patients treated with these regimens.

- Compare the distant metastatic rate in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter clinical trial. Patients are stratified according
to participating center, gender, age. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4
weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6
weeks, from 8-12 weeks after operation.

- Arm II: Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and
undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI
for 7 cycles from 2-4 weeks after operation.

After completion of study treatment, patients are followed every 3 months for 2 years, and
then every 6 months for at least 3 years.

The side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant
metastatic rate and 5-year survival rate will be investigated.

PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 5 year.


Inclusion Criteria:



1. Diagnosis of Adenocarcinoma of the rectum

2. Age:18-80 years old

3. Received curative resection when diagnosed as rectal cancer

4. Local recurrence happened >6 months after operation,without distant metastasis

5. Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days
prior recruit, meet the following criteria:

- Hematopoietic

- Absolute neutrophil count ≥ 1,500/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 ≤ 2.5 times ULN

- ALT ≤ 2.5 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

7.ECOG status: 0~1

Exclusion Criteria:

1. Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or
cloacogenic carcinoma)

2. Synchronous colon cancer

3. Hypersensitivity to fluorouracil

4. No More than 4 weeks since prior participation in any investigational drug study

5. Clear indication of involvement of the pelvic side walls by imaging With distant
metastasis

6. History of invasive rectal malignancy, regardless of disease-free interval Fertile
patients must use effective contraception

7. Uncontrolled hypertension

8. Cardiovascular disease that would preclude study treatment or follow-up

9. Lack of upper gastrointestinal tract integrity or malabsorption syndrome,active upper
gastrointestinal tract bleeding

10. Pregnant or nursing, Fertile patients do not use effective contraception

11. 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

12. 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:

5-year disease free survival

Outcome Description:

Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Ping Lan, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

GIHSYSU02

NCT ID:

NCT01271192

Start Date:

December 2010

Completion Date:

December 2020

Related Keywords:

  • Rectal Cancer
  • local recurrent rectal cancer
  • surgical resection
  • adjuvant therapy
  • Rectal Neoplasms

Name

Location