Have you or your loved ones been diagnosed with rectal cancer?

You may be eligible to participate in a rectal cancer clinical trial.

Have you or your loved ones been diagnosed with rectal cancer? You may be eligible to participate in a rectal cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Rectal Cancer Clinical Trial in Guangzhou Guangdong

NCT01271192 | Interventional

Have you or your loved ones been diagnosed with rectal cancer?

You may be eligible to participate in a rectal cancer clinical trial.

Have you or your loved ones been diagnosed with rectal cancer? You may be eligible to participate in a rectal cancer clinical trial.

Recruiting

Male & Female

18 - 80

Years old

This study is looking to recruit 360 Participants

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown. PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.

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Details for the study

Brief Title

Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer

Official Title

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

Brief Summary

RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown. PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.

Detailed Description

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.

Treatments and/or Procedures

Neoadjuvant followed by operation

Preoperative: Drug: fluorouracil Given IV continuously,Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks Postoperative: Drug: fluorouracil Given IV continuously,Irinotecan Given IV

Surgical resection and adjuvant therapy

Postoperative: Drug: fluorouracil Given IV continuously, Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

5-year disease free survival

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

5 years

Secondary

Side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate,biomarkers, quality of life, toxic profile, convenience

Compare the postoperative complications in patients treated with these regimens Compare the recurrent rate in these patients Compare the distant metastatic rate in these patients Compare preoperative quality of life (QOL) of patients. Compare the toxic effects of these regimens in these patients. Compare the convenience of care in patients treated with these regimens

5 years

Study Criteria

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