Triplet Combination or Doublet Regimen Versus Chemoradiation as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT03975049|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Preoperative radiation with single agent chemotherapy as sensitizer is the standard care of locally advanced rectal cancer.
Local irradiation significantly increases surgical complications and impairs quality of life.
Combination chemotherapy alone seems promising and provides similar benefit to chemoradiation as neoadjuvant therapy.
Early administration of systemic therapy is also proved beneficial for long-term survival.
The purpose of this study is to compare the efficacy of chemotherapy alone with short-term modified FOLFOXIRI or long-term mFOLFOX with standard chemoradiation as neoadjuvant therapy for locally advanced rectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer Chemotherapy Effect||Radiation: Chemoradiation Drug: FOLFOXIRI Protocol Drug: Folfox Protocol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||933 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospectively Randomized Phase III Trial Comparing Short-term mFOLFOXIRI, Long-term mFOLFOX6 and Traditional Chemoradiation as Preoperative Neoadjuvant Therapy for Locally Advanced Rectal Cancer|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2029|
Active Comparator: 5-Fu + RT
5Fu + RT for five weeks --- 6-8 weeks of interval --- TME --- mFOLFOX * 6-8
Fluorouracil 225 mg/m2/day continuous intravenous infusion on weekdays for five weeks; local irradiation 2GY/day on weekdays, totally 50GY.
mFOLFOXIRI * 4 --- TME --- mFOLFOXIRI * 4
Drug: FOLFOXIRI Protocol
Oxaliplatin 85 mg/m2 on day 1; irinotecan 150 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days; prophylactic G-CSF support is recommended.
mFOLFOX * 9 --- TME --- mFOLFOX * 3
Drug: Folfox Protocol
Oxaliplatin 85 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 400 mg/m2 bolus and 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days.
- Disease-free survival [ Time Frame: 3 years ]The interval from randomization to local recurrence, distant metastasis, death or the last follow-up.
- Recurrence-free survival [ Time Frame: 3 years ]The interval from randomization to local recurrence, death or the last follow-up.
- Metastasis-free survival [ Time Frame: 3 years ]The interval from randomization to distant metastasis, death or the last follow-up.
- Surgical complication [ Time Frame: 3 years ]Surgical complication including anastomotic leakage, anastomotic stricture, intestinal obstruction, postoperative pelvic bleeding and poor wound healing.
- Treatment related quality of life [ Time Frame: up to 3 years ]EORTC QOL questionaire
- Tumor regression grade after neoadjuvant therapy [ Time Frame: 3 months ]According to pathological slides
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975049
|Contact: Ping Lan, MDemail@example.com|
|Contact: Jian Xiao, MDfirstname.lastname@example.org|
|Principal Investigator:||Ping Lan, MD||Sixth Affiliated Hospital, Sun Yat-sen University|