Protocol digest of a single-arm confirmatory trial for less intensive postoperative surveillance in low-risk colorectal cancer patients: JCOG1915 (less study)

Q: What is the clinical evidence from this study?

Population: Stage I or low-risk stage II colorectal cancer (n=680). Intervention: Less-intensive postoperative surveillance. Primary outcome: Overall survival.

Q: What does this research mean for the field?

Less-intensive postoperative surveillance after curative resection can maintain overall survival while reducing medical costs in low-risk stage I and II colorectal cancer patients. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Yuta Sekino; Konosuke Moritani; Junki Mizusawa; Dai Shida; Shunsuke Tsukamoto; Tetsuya Hamaguchi; Atsuo Takashima; Akio Shiomi; Masaaki Ito; Yuichi Takayama; Makoto Kinouchi; Shin Fujita; Manabu Shiozawa; Hideki Ueno; Satoshi Ikeda; Yasumasa Takii; Yusuke Sano; Tomoko Kataoka; Haruhiko Fukuda; Yukihide Kanemitsu

doi:10.1093/jjco/hyaf077

Key result

Protocol evaluates less-intensive postoperative surveillance for overall survival in low-risk colorectal cancer patients.

n=680

Figures

Why the study?

There is no global consensus on the optimal method, duration, or frequency of postoperative surveillance in colorectal cancer, and no clinical trials have demonstrated its usefulness.

Does less-intensive postoperative surveillance maintain overall survival in patients with stage I or low-risk stage II colorectal cancer?

Key Points

To confirm the efficacy of a reduced postoperative surveillance regimen compared to standard intensive monitoring in patients with curatively resected, low-risk colorectal cancer.
Interventional single-arm confirmatory trial (JCOG1915, jRCT1030220350) targeting 680 patients across 59 Japanese institutions over a 2-year enrollment period.
Eligible patients have pathological stage I or low-risk stage II colorectal cancer treated with curative R0 resection and lymph node dissection, without clinical risk factors for recurrence.
Patients undergo a less intensive postoperative surveillance schedule, with overall survival designated as the primary endpoint.
Clinical outcomes are currently pending completion of patient accrual across the 59 participating multicenter trial sites.
Successful demonstration of non-compromised overall survival is expected to significantly reduce unnecessary postoperative surveillance procedures and healthcare costs.

Structured PICO

Does less-intensive postoperative surveillance maintain overall survival in patients with stage I or low-risk stage II colorectal cancer?

P

Population

A planned single-arm trial enrolling 680 patients with stage I or low-risk stage II colorectal cancer without risk factors for recurrence after R0 resection.

I

Intervention

Less-intensive postoperative surveillance

O

Outcome

Overall survivalhard clinical

This protocol outlines a single-arm trial to evaluate whether less-intensive surveillance is effective for low-risk colorectal cancer patients, which could considerably reduce medical costs.

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Implication

Should not yet change surveillance practice; leaves open non-inferior survival with de-intensified monitoring in low-risk colorectal cancer.

Abstract

The Japanese Society for Cancer of the Colon and Rectum guidelines recommend intensive surveillance for curatively resected pathological stage I-III colorectal cancer. However, there is still no global consensus on the optimal method, duration, or frequency of surveillance, and no clinical trials have demonstrated the usefulness of surveillance. We are conducting a clinical trial to confirm the efficacy of less-intensive surveillance after R0 resection with lymph node dissection for stage I or low-risk stage II colorectal cancer in patients without risk factors for recurrence. If this less intensive surveillance method proves effective, medical costs will be considerably reduced. The primary endpoint is overall survival. A total of 680 patients will be enrolled from 59 institutions over 2 years. This trial has been registered at the Japan Registry of Clinical Trials (jRCT) as study number jRCT1030220350.

Discussion

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Cite This Study

Sekino et al. (2025) studied Stage I or low-risk stage II colorectal cancer (n=680). Less-intensive postoperative surveillance was evaluated on Overall survival. This is a protocol for a single-arm confirmatory trial evaluating less-intensive postoperative surveillance for overall survival in 680 low-risk colorectal cancer patients.

synapsesocial.com/papers/6aa9248017cf531f2326349c https://doi.org/10.1093/jjco/hyaf077

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Protocol digest of a single-arm confirmatory trial for less intensive postoperative surveillance in low-risk colorectal cancer patients: JCOG1915 (less study)

Figures

Key Points

Structured PICO

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Protocol digest of a single-arm confirmatory trial for less intensive postoperative surveillance in low-risk colorectal cancer patients: JCOG1915 (less study)

Figures

Key Points

Structured PICO

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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