Adjuvant Chemotherapy in Patients With Clinical Stage III Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy

Phase 3

Recruiting

• Conditions: Rectal Neoplasms
• Interventions: Drug: mFOLFOX6 or CAPOX; Drug: Capecitabine

• Registration Number: NCT03415763
• Lead Sponsor: LI XIN-XIANG

Brief Summary

The purpose of this study is to evaluate the efficacy of adjuvant chemotherapy in patients with clinical stage III rectal cancer who received neoadjuvant chemoradiotherapy on the basis of postoperative pathological stage.

Detailed Description

Previous studies have proved that neoadjuvant radiotherapy can decrease the rate of local recurrence rather than distal metastases in advanced rectal cancer. Moreover, the local control was not responsible for survival benefit. Adjuvant chemotherapy is capable of eliminating the micrometastasis, rendering better prognosis to rectal cancer. However, the application of adjuvant chemotherapy depends largely on the evidence from colon cancer. At present, controversy remains on the clinical value of adjuvant chemotherapy in patients with rectal cancer who received neoadjuvant chemoradiotherapy. Besides that, the pathological stage followed by neoadjuvant chemoradiotherapy may have an effect on the evaluation of adjuvant chemotherapy. According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Status Verified: 2018-11
• Study Start: 2018-11-05
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06
• Primary Completion: 2020-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 764

Inclusion Criteria

• The lesion must be within 12 cm of the anus as measured by endoscopy
• Histologically confirmed diagnosis of rectal carcinoma
• CT, MRI and EUS verified as clinical stage III rectal cancer without involvement of other organs
• Without multiple primary cancer
• Sufficient organ function
• Able to provide written informed consent

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Exclusion Criteria

• Younger than 18 years or older than 75 years
• Synchronous or metachronous malignancy within 5 years.
• Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
• Patients with a history of pelvic irradiation.
• ASA grade IV or V.
• Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding.
• Severe mental illness.
• Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
• Patients who received steroid therapy within one month.
• Patients or family members misunderstand the conditions and goals of this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mFOLFOX6 or CAPOX	mFOLFOX6 or CAPOX	Oxaliplatin combined with 5-fluorouracil for patients with yp stage II or III mFOLFOX6 (leucovorin 400 mg/m2 as a 2-hour infusion, and the concurrent administration of oxaliplatin 85 mg/m2 as a 2-hour infusion, followed by a bolus of 5-FU 400 mg/m2 within 15 min and 46-hour infusion of 5-FU 2400 mg/m2 on day 1 every 2 weeks), three cycles or CAPOX (oxaliplatin 130 mg/m2 as a 2-hour infusion on day 1, followed by capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks), three cycles( According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone)
5-fluorouracil	Capecitabine	Capecitabine for patients with pathological complete response or yp stage I Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil )
5-fluorouracil alone	Capecitabine	5-fluorouracil alone for patients with yp stage II or III Capecitabine 1250 mg/m2 twice daily for 14 days in a 3-week cycle to be administered orally after food, three cycles(According to the postoperative pathological stage, the present study was designed as a superiority trail for patients with yp stage II or III to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone)

Primary Outcome Measures

Name	Time	Method
Disease free survival	3-year	Calculated from the date of surgery to the date of recurrence

Secondary Outcome Measures

Name	Time	Method
The rate of adverse events resulted from chemotherapy	3-year	The ratio of the number of patients experienced adverse events to the total patients
The quality of life postoperatively	3-month, 6-month, 9-month, 12-month, 18-month, 24-month	The European Organization for Research and Treatment (EORTC)-QLQ-C30 HRQL questionnaire was assessed with repeated measures at regular intervals postoperatively at months 3, 6, 9, 12, 18, and 24
Disease free survival	5-year	Calculated from the date of surgery to the date of recurrence
The rate of local recurrence	3-year	The ratio of the number of local recurrence to the total patients
Overall survival	3-year, 5-year	Calculated from the date of diagnosis to the date of death from any cause

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China