Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy

Kyung Hee University

Status and phase: Enrolling; Phase 3

Conditions: Rectal Cancer

Treatments: Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02843191

KSCP2016

Details and patient eligibility

About

This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.

Enrollment: 358 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed adenocarcinoma of mid or low rectum

2. Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)

   • Clinical stage T1-3N1or2 on MRI
   • Clinical stage cT3N0 (or depth of perirectal invasion by tumor >5mm on MRI)
   • Suspicious of circumferential invasion on MRI (or circumferential margin <1mm)

3. ECOG performance status of 0-2

4. ASA grade ≤ 3

5. An informed consent has been signed by the patient

Exclusion criteria

1. Upper rectal cancer
2. Clinical stage T1or2N0 on MRI
3. Clinical stage T4Nany on MRI
4. Clinical stage TanyNanyM1 by image or histology
5. The patient received chemotherapy or radiotherapy during the past 6 months
6. The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
7. The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
8. Pregnant of breastfeeding women
9. The patient who participate in another clinical trial, or receives any drug for the trial
10. Uncontrolled peripheral neuropathy (more than grade 2)
11. Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
12. Active gastrointestinal bleeding
13. Patients with an active infection, which needs antibiotic therapy, during the randomization period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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358 participants in 2 patient groups

Adjuvant chemotherapy

Active Comparator group

Description:

After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.

Treatment:

Drug: Chemotherapy

Consolidation chemotherapy

Experimental group

Description:

After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.

Treatment:

Drug: Chemotherapy