Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Phase 2

• Conditions: Rectal Cancer
• Interventions: Drug: XELOX; Drug: Capecitabine

• Registration Number: NCT02022852
• Lead Sponsor: Harbin Medical University

Brief Summary

Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.

Detailed Description

The patients were divided into two arms according to the defined conditions (pathology rectal adenocarcinoma；distal distance of tumor from anal verge \< 10cm；TNM staging T3-4N0-2；no distant metastasis；Karnofsky score≥70) in this prospective, single center, open, non randomized trail (arm A:concurrent chemoradiotherapy, arm B:sequential therapy). Regimens:Arm A:50Gy,2Gy/day per time, 5 days a week, for 5 weeks. +capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks. Arm B: XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1, capecitabine 1000 mg/m2 Bid day 1-14, repeat every 3 weeks ) → 50Gy,2Gy/day per time, 5 days a week, for 5 weeks.+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks. Evaluate pre chemotherapy, pre radiotherapy and pre surgery individually. Surgeries followed TME(total mesorectal excision) and PANP(pelvic autonomic nerve preservation) for patients in both arms. Take pathological evaluation of tumors. Take XELOX therapy till 6-8 cycles(pre and after surgery total). Follow up according the schedule.

Study Timeline

• Study Start: 2013-07
• Status Verified: 2013-12
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-23
• Last Update Submitted: 2013-12-23
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30
• Primary Completion: 2015-07
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Pathology rectal adenocarcinoma
• Distal distance of tumor from anal verge < 10cm
• TNM staging T3-4N0-2(MRI)
• No distant metastasis
• Karnofsky score≥70
• Female patients need contraception during the test
• Postmenopausal women for at least 12 months, expect pregnancy possibility
• Patients did not receive chemotherapy, radiotherapy in any form before
• No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.)

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Exclusion Criteria

• Be treated by radiotherapy, chemotherapy or tumor biological therapy before
• Received immunosuppressive therapy (including corticosteroids)
• Participated in other clinical trial(s) in 1 month
• With malignant tumor of colon
• Peripheral neuropathy (WHO I level and above)
• Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis
• Severe allergies or allergic history
• Severe pulmonary or heart disease
• Pregnant or lactation or refuse contraception during the test
• Suffering other malignant tumors in past

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential therapy	XELOX	XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy
Concurrent chemoradiotherapy	Capecitabine	Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy

Primary Outcome Measures

Name	Time	Method
Disease free survival	3-year

Secondary Outcome Measures

Name	Time	Method
R0 resection rate	1 year
Pathologic complete response	1 year
Local recurrence rate	3 years
Safety: Number of Participants with Adverse Events	3 years

Trial Locations

Locations (1)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China