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

NCT03415763 | Unknown Phase 3 DMC

• 1 other identifier: Fudan AC
• Study Type: interventional
• Target: 764
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Keywords

Rectal Neoplasms; Adjuvant Chemotherapy; Neoadjuvant Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Calculated from the date of surgery to the date of recurrence

  3-year

Secondary Outcomes (5)

• Overall survival

  3-year, 5-year

• Disease free survival

  5-year

• The rate of local recurrence

  3-year

• The rate of adverse events resulted from chemotherapy

  3-year

• The quality of life postoperatively

  3-month, 6-month, 9-month, 12-month, 18-month, 24-month

Study Arms (4)

Observation

NO INTERVENTION

Observation for patients with pathological complete response or yp stage I(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

EXPERIMENTAL

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 )

Drug: Capecitabine

5-fluorouracil alone

EXPERIMENTAL

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)

Drug: Capecitabine

mFOLFOX6 or CAPOX

EXPERIMENTAL

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)

Drug: mFOLFOX6 or CAPOX

Interventions

Capecitabine DRUG

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.

Also known as: Xeloda

5-fluorouracil; 5-fluorouracil alone

mFOLFOX6 or CAPOX DRUG

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.

Also known as: 5-Fu-leucovorin-oxaliplatin or xeloda-oxaliplatin

mFOLFOX6 or CAPOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LI XIN-XIANG: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Li Q, Luo D, Zhu J, Yang L, Liu Q, Ma Y, Liang L, Cai S, Zhang Z, Li X; ACRNaCT study group. ACRNaCT trial protocol: efficacy of adjuvant chemotherapy in patients with clinical T3b/T4, N+ rectal Cancer undergoing Neoadjuvant Chemoradiotherapy: a pathology-oriented, prospective, multicenter, randomized, open-label, parallel group clinical trial. BMC Cancer. 2019 Nov 15;19(1):1117. doi: 10.1186/s12885-019-6289-6.

  PMID: 31729964 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; XELOX

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xinxiang Li, MD,PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinxiang Li, MD,PhD

CONTACT

86-13918176716; lxx1149@163.com

Qingguo Li, MD,PhD

CONTACT

86-18918298120; 13111230016@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 30, 2018
• Study Start: November 5, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2025
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)