Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer

Harbin Medical University

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Drug: Capecitabine; Drug: XELOX

Study type: Interventional

Funder types: Other

Identifiers

NCT02022852

HarbinMU-BCui-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Concurrent chemoradiotherapy

Active Comparator group

Description:

Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy

Treatment:

Drug: Capecitabine

Sequential therapy

Experimental group

Description:

XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy

Treatment:

Drug: XELOX