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Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

Primary Purpose

Locally Advanced Colon Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

capecitabine plus oxaliplatin before and after surgery

capecitabine plus oxaliplatin after surgery

About this trial

This is an interventional treatment trial for Locally Advanced Colon Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109/L, Platelet count≥100×109/L, Hemoglobin≥80g/L, Serum bilirubin≤24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60×IU/L, Serum creatinine≤110 umol/L;
No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception ;
Be in a condition to receive a surgery/procedure;
No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer;
No previous systemic chemotherapy for treating colon cancer;
No other chemotherapy at the same time;
Expected lifetime longer than three months;
Be willing and able to understand the study and to provide written informed consent.

Exclusion Criteria:

End-stage cachexia patients;
Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy;
Metastatic carcinoma;
Moderate or above anemia caused by serious local tumor bleeding;
Incomplete or complete intestinal obstruction;
Known to be allergic to oxaliplatin or capecitabine;
Active hepatitis, severe coagulation disorder patients;
Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures;
Known to have deficient dihydropyrimidine dehydrogenase (DPD)；
Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric history；severe infection; active disseminated intravascular coagulation;
Unable or unwilling to abide by the study plan.

Sites / Locations

Department of Colorectal Surgery Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Perioperative chemotherapy with CapOX regimen

Postoperative chemotherapy with CapOX regimen

Arm Description

Outcomes

Primary Outcome Measures

3-year disease free survival

Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first

Secondary Outcome Measures

R0 resection rate

Defined as the rate of patients whose tumors are completely resected with all the margins being negative

Post-operative TRG staging

Defined as the TRG staging of tumor after surgery

Overall survival (OS)

Defined as the length of time from randomization date until the date of death from any cause

Relapse-free survival (RFS)

Defined as the length of time from the date of randomization until the first documented date of relapse.

Full Information

NCT ID

NCT03125980

First Posted

April 14, 2017

Last Updated

April 19, 2017

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03125980

Brief Title

Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

Official Title

Perioperative CapeOX Chemotherapy Versus Postoperative Chemotherapy for Locally Advanced Resectable Colon Cancer: An Open Label Randomized Controlled Phase III Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Recruiting

Study Start Date

May 2017 (Anticipated)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Adjuvant chemotherapy has been widely adopted worldwide for locally advanced colon cancer. However, more and more studies have found better efficacy and potential advantages of perioperative or neoadjuvant chemotherapy. The sooner the systemic chemotherapy is received, the better suppression it has on activity of tumor growth factors. Pre-operative chemotherapy may eliminate tiny metastases. It may also shrink the invasion of tumor before surgery, and thus reducing operational trauma and expediting recovery. With advances in radiology and tomography, staging before surgery is accurate enough to identify risks and prognosis for patients. The phase II trial conducted by our department has yielded encouraging results (N=47, CapeOX regimen, clinicaltrials.gov NCT02415829): after the neoadjuvant chemotherapy, no subject had disease progression, 68.1% subjects reached complete or partial response. Besides, the toxicity of neoadjuvant CapeOX chemotherapy was acceptable. The present randomized controlled phase III trial will be conducted to further compare efficacy and safety of the neoadjuvant and adjuvant CapeOX chemotherapy for patients with locally advanced resectable colon cancer in China. This study may have two periods, each will last for approximately 5 years. After the first period (n=994), if the results of the test group are better than the control group, the study will be terminated. Otherwise, the study will enter into period 2 (n=376) through selecting out genetically sensitive subjects and repeating the same trial process as period 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Colon Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

Open label

Allocation

Randomized

Enrollment

1370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Perioperative chemotherapy with CapOX regimen

Arm Type

Experimental

Arm Title

Postoperative chemotherapy with CapOX regimen

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

capecitabine plus oxaliplatin before and after surgery

Intervention Description

Subjects will receive systemic CapeOX chemotherapy both before and after the radical surgery for at most 4 cycles respectively. They shall have rest after the surgery for at least four weeks before the post-operative chemotherapy. CapOX regimen will be administered as follows: Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 Repeat every 3 weeks (Q3W)

Intervention Type

Drug

Intervention Name(s)

capecitabine plus oxaliplatin after surgery

Intervention Description

Subjects will first receive radical surgery, then have rest for at least four weeks. Thereafter, subjects will receive systemic CapeOX chemotherapy for at most 8 cycles. CapOX regimen will be administered as follows: Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 Q3W

Primary Outcome Measure Information:

Title

3-year disease free survival

Description

Defined as the length of time from the date of randomization until the first documented date of progression or death from any cause, whichever comes first

Time Frame

3 years

Secondary Outcome Measure Information:

Title

R0 resection rate

Description

Defined as the rate of patients whose tumors are completely resected with all the margins being negative

Time Frame

From the date of randomization until the date of the last patient receiving surgery, assessed up to 40 months

Title

Post-operative TRG staging

Description

Defined as the TRG staging of tumor after surgery

Time Frame

From the date of randomization until the date of the last patients receiving surgery, assessed up to 40 months

Title

Overall survival (OS)

Description

Defined as the length of time from randomization date until the date of death from any cause

Time Frame

5 years

Title

Relapse-free survival (RFS)

Description

Defined as the length of time from the date of randomization until the first documented date of relapse.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2; Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Neutrophil count≥1.5×109/L, Platelet count≥100×109/L, Hemoglobin≥80g/L, Serum bilirubin≤24umol/L, Alanine aminotransferase and aspartate aminotransferase ≤ 60×IU/L, Serum creatinine≤110 umol/L; No current pregnancy or breast-feeding, and subjects at childbearing age shall take method of contraception ; Be in a condition to receive a surgery/procedure; No second tumor at present or in the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, or any in situ cancer; No previous systemic chemotherapy for treating colon cancer; No other chemotherapy at the same time; Expected lifetime longer than three months; Be willing and able to understand the study and to provide written informed consent. Exclusion Criteria: End-stage cachexia patients; Cardiopulmonary dysfunction or liver and kidney dysfunction, and unable to tolerate CapeOX chemotherapy; Metastatic carcinoma; Moderate or above anemia caused by serious local tumor bleeding; Incomplete or complete intestinal obstruction; Known to be allergic to oxaliplatin or capecitabine; Active hepatitis, severe coagulation disorder patients; Pregnant or lactating women; or women who have fertility but have not taken at taken adequate contraceptive measures; Known to have deficient dihydropyrimidine dehydrogenase (DPD)； Have vital organ failure or other severe diseases, including but not limited to coronary heart disease, cardiovascular diseases, or myocardial infarction within 12 months before being included; severe neurological or psychiatric history；severe infection; active disseminated intravascular coagulation; Unable or unwilling to abide by the study plan.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sanjun Cai, M.D

Phone

+86-21-64175590

Ext

81108

caisanjuncsj@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Xu, M.D

Organizational Affiliation

Department of Colorectal Surgery Fudan University Shanghai Cancer Center

Official's Role

Study Director

Facility Information:

Facility Name

Department of Colorectal Surgery Fudan University Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sanjun Cai, M.D

Phone

+86-21-64175590

Ext

81108

caisanjuncsj@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

30700474

Citation

Liu F, Tong T, Huang D, Yuan W, Li D, Lin J, Cai S, Xu Y, Chen W, Sun Y, Zhuang J. CapeOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced resectable colon cancer: protocol for a two-period randomised controlled phase III trial. BMJ Open. 2019 Jan 29;9(1):e017637. doi: 10.1136/bmjopen-2017-017637.

Results Reference

derived

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Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

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