Two-week Course Versus Conventionally Fractionated Chemoradiotherapy in Rectal Cancer

Phase 3

• Conditions: Response to Toxin; Toxicity; Recurrence
• Interventions: Drug: Two-week course of radiation

• Registration Number: NCT02484040
• Lead Sponsor: Jong Hoon Lee

Brief Summary

The investigators compare two-week course of chemoradiation (33 Gy in 10 fractions with oral capecitabine) and conventional chemoradiation (50.4 Gy in 28 fractions with 5-FU and leucovorin) in this randomized trial.

Detailed Description

1.1 experimental arm Two-week course concurrent chemoradiotherapy

* Radiotherapy, 33 Gy/10 fractions for 2 weeks

↓↓↓↓↓ ↓↓↓↓↓ Radical surgery 6 weeks after completion of chemoradiotherapy D1----------------------D12

* Capecitabine 825 mg/m2, twice daily

1.2 control arm

Standard concurrent chemoradiotherapy (CRT)

* Radiotherapy, 50.4 Gy/28 fractions for 6 weeks

↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓↓↓ ↓↓↓ Radical surgery D1--------------------------------------------------------------------------D38

* Bolus 5-FU, 400 mg/ m2 and leucovorin, 20 mg/ m2 during week 1 and 5

* Capecitabine, 825 mg/ m2, bid

Study Timeline

• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-29
• Study Start: 2015-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-05
• Primary Completion: 2019-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

1. histologically confirmed adenocarcinoma;
2. distal margin of the tumor located < 10 cm from the anal verge;
3. cT3-4N0-2 classification as determined by magnetic resonance imaging (MRI) and/or endorectal ultrasonography (EUS);
4. no evidence of distant metastasis;
5. Karnofsky performance score over 70;
6. adequate bone marrow, liver, and renal function (leucocytes >4000/mm3, hemoglobin >10 g/dL, platelets >100,000/mm3; serum bilirubin <1.5 mg/dL, serum transaminase <2.5 times the upper normal limit; serum creatinine <1.5 mg/dL).

Exclusion Criteria

1. Metastatic disease
2. No complete resection of tumor (R2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two-week course arm	Two-week course of radiation	Experimental arm receive 33 Gy in 10 fractions of radiation for 2 weeks with oral capecitabine. Two-week course of radiation, 33 Gy/10 fx and oral capecitabine, 825 mg/m2, bid

Primary Outcome Measures

Name	Time	Method
Tumor response from stage II-III to stage 0-I	from clinical staging time to radical surgery date (about 3 months)	Downstaging rate was evaluated by comparing pre-clinical and post-CRT pathological stages, and downstaging was defined as ypStage 0-I (ypT0-2N0M0)

Secondary Outcome Measures

Name	Time	Method
Toxicity (acute and chronic)	from radiation start to 3 years after radical surgery	During the course of radiotherapy, patients were evaluated weekly to assess acute toxicity. Patients were also followed 2 and 4 weeks after completion of radiotherapy and until 3 years after curative surgery to assess toxicity. Toxicity are assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Recurrence and survival	3-year recurrence-free survival and 3-year overall survival

Trial Locations

Locations (1)

Lee Jong Hoon; 🇰🇷 Suwon, Korea, Republic of