Health TrialsbyHealthPanel

Outcome of Neoadjuvant Chemotherapy for Obstructive Colon Cancer

ConditionColon Cancer, Obstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-74
SponsorThe Catholic University of Korea

About this trial

In this study, patients with obstructive colon cancer will be divided into two groups; in the control group, curative surgery will be performed within 2 weeks after successful SEMS placement, and in the experimental group, 3 cycles of neoadjuvant chemotherapy will be administered into patients who undergo successful SEMS placement and then curative surgery will be performed after neoadjuvnat chemotherapy. After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles. The primary end points is overall survival, also the short-term perioperative outcomes and long-term oncological outcomes will be compared between the control and experimental group. Random allocation will be carried out with the consent of patients and their guardians after successful SEMS placement, and 204 patients will be distributed between the two groups by 1:1.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

i. Age : 20 years old or more and lesser than 75 years old ii. Agreement of this study iii. Clinical stage II or III colon cancer with colonic obstruction which is confirmed by pathologic review and imaging study.

Disqualifiers

i. any suspicious distant metastasis ii. any other primary malignant lesion iii. Clinical stage T1or T2 and N0 iv. the sign of perforation or severe ischemia requiring ememgency operation v. the complication related to SEMS placement (severe bleeding and perforation after SEMS placement) vi. ASA 4 or more vii. ECOG 3 or more viii. colonic obstruction by benign stricture ix. pregnant woman or woman who is breastfeeding x. the paitents who already enrolled into other study or are taking medicine related to any clinical trial xi. the patients who are taking sorivudine xii. the patients who are taking Tegafur/gimeracil/oteracil xiii. the patietns who have a medical history of hypersensitivity reaction to 5-FU, oxaliplatin, leucovorin,or any medication including platinum.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant chemotherapy

    Drug

    In this study, patients with obstructive colon cancer will be divided into two groups; in the control group, curative surgery will be performed within 2 weeks after successful SEMS placement, and in the experimental group, 3 cycles of neoadjuvant chemotherapy will be administered into patients who undergo successful SEMS placement and then curative surgery will be performed after neoadjuvnat chemotherapy. After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.

  • Adjuvant chemotherapy

    Drug

    After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.

  • Curative resection

    Procedure/Surgery

    After successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: The Control groupActive comparator 2 interventions
Group B: The Experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

3-year overall survival

3-year overall survival after curative surgery

Time frame
3 years after surgery

Secondary outcomes

1

postoperative complication rate

postoperative ileus, reoperation rate, wound infection, ..

Time frame
within 30 days after surgery
2

stoma formation rate

stoma formation rate withing 30 days after surgery

Time frame
within 30 days after surgery
3

pathologic result

TNM stage, lymphovascular invasion, silent perforation....

Time frame
within 30 days after surgery
4

recurrence rate

recurrent rate after curative surgery within postoperative 3 years

Time frame
3 years after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

The Catholic University of Korea

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: