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

Phase 3

Active, not recruiting

• Conditions: Rectal Cancer
• Interventions: Drug: Chemotherapy

• Registration Number: NCT02843191
• Lead Sponsor: Kyung Hee University Hospital at Gangdong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-25
• Study Start: 2016-12-07
• Primary Completion: 2023-07-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 358

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant chemotherapy	Chemotherapy	After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.
Consolidation chemotherapy	Chemotherapy	After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.

Primary Outcome Measures

Name	Time	Method
Pathologic complete response	2 years	Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)
Disease-free survival	3 years	The rates of patients who survive without recurrence

Secondary Outcome Measures

Name	Time	Method
Peripheral neuropathy	3 years	Peripheral neuropathy will be evaluated as grade 1 to 4 according to NCI CTCAE 4.0.
Radiotherapy-related complications	2 years	Complications according to the CTCAE 4.0
R0 resection	2 years	R0 resection is defined as resection without remnant tumor, whereas R1 resection as microscopic residual tumor and R2 resection as gross residual tumor. R0 resection will be proven histologically as no resection margin involvement of tumor.
Tumor response rate	2 years	Amount of tumor regression after surgery according to the guideline including Mandard or Dworak
Postoperative complications	2 years	Complications after surgery

Trial Locations

Locations (14)

Inje University Busan Paik hospital; 🇰🇷 Busan, Korea, Republic of

Soonchunhyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of

Chuncheon Sacred Heart Hospital, Hallym University College of Medicine; 🇰🇷 Chuncheon, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Korea, Republic of

Wonkwang University Hospital; 🇰🇷 Iksan, Korea, Republic of

Inje University Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital, The Catholic University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Ajou University School of Medicine; 🇰🇷 Suwon, Korea, Republic of

Uijeongbu St. Mary's Hospital, The Catholic University College of Medicine; 🇰🇷 Uijeongbu, Korea, Republic of

Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine; 🇰🇷 Wonju, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of