Health TrialsbyHealthPanel

Perioperative Versus Postoperative CapOX Chemotherapy for Locally Advanced Colon Cancer

ConditionLocally Advanced Colon Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • capecitabine plus oxaliplatin before and after surgery

    Drug

    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: 1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 3. Repeat every 3 weeks (Q3W)

  • capecitabine plus oxaliplatin after surgery

    Drug

    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: 1. Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1 2. Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14 3. Q3W

Treatment groups

1,370 Participants
are divided into 2 treatment groups
Group A: Perioperative chemotherapy with CapOX regimenExperimental treatment 1 intervention
Group B: Postoperative chemotherapy with CapOX regimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 years

Secondary outcomes

1

R0 resection rate

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
2

Post-operative TRG staging

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
3

Overall survival (OS)

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

Time frame
5 years
4

Relapse-free survival (RFS)

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
Apply now