Short-course Radiotherapy or Long-course Chemoradiation Followed by MFOLFOXIRI Consolidation Chemotherapy for Organ Preservation in Low Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 12, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Rectal Neoplasms
Interventions
RADIATION

Short-course radiotherapy

The total dosage was 25Gy consisted of 5 fractions of 5 Gy to clinical target volume without a boost dose

DRUG

Irinotecan

150 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.

DRUG

Oxaliplatin

85 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.

DRUG

Calcium Formate

400 mg/m² iv drip over 2 hours on day 1, repeated every 14 days.

DRUG

Fluorouracil

2400 mg/m² iv drip over 48 hours on day 1-2, repeated every 14 days.

RADIATION

Long-course chemoradiation

The total dosage was 50Gy consisted of 25 fractions of 2 Gy to clinical target volume without a boost dose

DRUG

Capecitabine

825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week.

Trial Locations (1)

510060

RECRUITING

651 Dongfeng Road East, Guangzhou

All Listed Sponsors
collaborator

Yunnan Cancer Hospital

OTHER

collaborator

Liaoning Cancer Hospital & Institute

OTHER

collaborator

Shantou Central Hospital

OTHER

collaborator

Fujian Cancer Hospital

OTHER_GOV

collaborator

Jiangsu Provincial People's Hospital

OTHER

lead

Pei-Rong Ding

OTHER