---
title: The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer
nct_id: NCT04416854
overall_status: UNKNOWN
phase: PHASE3
sponsor: Fudan University
study_type: INTERVENTIONAL
primary_condition: Metastatic Colon Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04416854.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04416854"
ct_last_update_post_date: 2020-06-04
last_seen_at: "2026-05-12T06:21:01.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

**Official Title:** The Value of Palliative Primary Tumor Resection in Colon Cancer Patients With Initially Unresectable Metastases After Induction Chemotherapy: a Prospective, Multicenter, Randomized Controlled Clinical Trial

**NCT ID:** [NCT04416854](https://clinicaltrials.gov/study/NCT04416854)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 627
- **Lead Sponsor:** Fudan University
- **Conditions:** Metastatic Colon Cancer, Surgery
- **Start Date:** 2020-04-01
- **Completion Date:** 2025-12-31
- **CT.gov Last Update:** 2020-06-04

## Brief Summary

The aim of this trial is to evaluate the value of palliative primary tumor resection in colon cancer patients with initially unresectable metastases and a positive response to induction chemotherapy which depends on gene testing. The primary endpoint is to evaluate overall survival.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 75 years old
* ECOG (Eastern Cooperative Oncology Group) 0-1 and expected survival period for 6 months or more
* Pathological diagnosis of colon cancer adenocarcinoma
* At least one measurable objective tumor lesions which could be evaluated.
* Primary and metastatic tumors exist at the same time, and distant metastases are not resectable
* ANC≥1.5\*109/L；PLT≥90\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤2.5ULN；Cr≤1.0(ULN) screening within 7 days
* No systemic chemotherapy
* Patients with voluntary participation, and sign the informed consent

Exclusion Criteria:

* Operation intervention required for perforation, bleeding and obstruction of intestinal cavity
* Multiple primary colorectal carcinoma
* Malignant peritoneal effusion or metastatic carcinoma of the peritoneum
* Uncontrolled pleural effusion
* Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas
* With brain metastasis or meningeal metastasis
* Pregnancy or breast-feeding women
* Alcohol or drug addictions
* There is an important organ failure or other serious diseases, including coronary artery disease, symptomatic cardiovascular disease or myocardial infarction within 12 months; serious neurological or psychiatric history; severe infection; actively disseminated vascula blood coagulation
```

## Arms

- **Chemotherapy plus surgery** (EXPERIMENTAL) — Chemotherapy plus surgery: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to surgery group. Patients receive palliative resection of Primary tumor. Then the rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.
- **Chemotherapy alone** (ACTIVE_COMPARATOR) — Chemotherapy alone: Four cycles of XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy accroding to gene testing. After 4 cycles, the patients are randomized to chemotherapy group. The rest four cycles XELOX or six cycles of mFOLFOX6 combined with or without targeted therapy are administrated.

## Interventions

- **resection of primary tumor** (PROCEDURE) — resection of primary lesion with unresectablely metastatic colon cancer
- **XELOX** (DRUG) — Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
- **mFOLFOX6** (DRUG) — Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1

## Primary Outcomes

- **Overall survival** _(time frame: 5-year)_

## Secondary Outcomes

- **Progression-free survival 1** _(time frame: 3-year)_
- **Progression-free survival 2** _(time frame: 3-year)_
- **The rate of adverse events resulted from chemotherapy** _(time frame: 3-year)_
- **The quality of life postoperatively** _(time frame: 3-month, 6-month, 9-month, 12-month, 18-month, 24-month)_
- **Objective response rate** _(time frame: 1-year)_
- **The rate of postoperative complications** _(time frame: 1-year)_
- **The proportion of surgical intervention in control group** _(time frame: 1-year)_

## Locations (1)

- Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fudan university shanghai cancer center|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04416854.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04416854*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*